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Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis

Primary Purpose

Relapsing Forms of Multiple Sclerosis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Fingolimod

About this trial

This is an interventional treatment trial for Relapsing Forms of Multiple Sclerosis focused on measuring Fingolimod, FTY720, Relapsing forms of MS, Multiple Sclerosis, Efficacy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

- Patients who have completed selected ongoing or planned trials with FTY720.

Key Exclusion Criteria:

Premature permanent discontinuation of a previous fingolimod study.
Pregnant or nursing (lactating) women.
Women of child-bearing potential, UNLESS they are using two birth control methods, at least 1 of which must be hormonal contraception, tubal sterilization, partner's vasectomy or intrauterine device.
Chronic disease of the immune system, other than multiple sclerosis, which may require immunosuppressive treatment.
Diabetic patients with moderate or severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy and uncontrolled diabetic patients with HbA1c > 8%.
Active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis B, Hepatitis C infection or have positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests.
Previous treatment with cladribine, cyclophosphamide or mitoxantrone.
Treatment with immunoglobulins and/or monoclonal antibodies (including Natalizumab) in the past 3 months during the previous fingolimod study:
Any of the following cardiovascular conditions that have developed during the previous fingolimod study:
- Myocardial infarction within the past 6 months prior to entry in the extension study or with current unstable ischemic heart disease;
- Cardiac failure (Class III, according to New York Heart Association Classification) or any severe cardiac disease as determined by the investigator;
- Arrhythmia requiring current treatment with Class III antiarrhythmic drugs (e.g., amiodarone, bretylium, sotalol, ibutilide, azimilide, dofetilide)
- History or presence of a third degree AV block
- Proven history of sick sinus syndrome or sino-atrial heart block
- Known history of angina pectoris due to coronary spasm or Raynaud's phenomenon
Any of the following pulmonary conditions during the previous fingolimod study:
- Severe respiratory disease or pulmonary fibrosis diagnosed (during the previous fingolimod study)
- Active tuberculosis
Alcohol abuse, chronic liver disease during the previous fingolimod study.

The patient must have participated in a previous fingolimod trial to be eligible to participate in this trial.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fingolimod 0.5 mg/day

Arm Description

Open-label fingolimod 0.5 mg, taken orally once daily

Outcomes

Primary Outcome Measures

Parts I and II: Number of Participants With Adverse Events, Serious Adverse Event, and Death

Analysis of absolute and relative frequencies for Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC) to demonstrate that Fingolimod 0.5 mg/day is safe in patients with relapsing forms of Multiple Sclerosis (MS) through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed.

Secondary Outcome Measures

Part I: Aggregate Annualized Relapse Rates (ARR) From First Dose of Fingolimod

Annualized relapse rate (ARR) is defined as the number of all relapses (including both confirmed and unconfirmed relapses) experienced during a specific period of time adjusted to a one-year period. ARR is calculated as follows: (total number of all relapses) / (total number of days in the study for all patients for that specific period of time) x 365.25. Month 0 is the first dose of fingolimod study drug among all studies in which patient participated. Only descriptive analysis performed.

Part I: Number of Participants With Relapses (Confirmed and Unconfirmed) From First Dose of Fingolimod

A relapse is defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (<37.5°C) or infection. In Study Part One, a relapse must be confirmed by an Expanded Disability Status Scale (EDSS) certified Physician within 7 days of the onset of symptoms. A relapse is confirmed when it is accompanied by an increase of at least half a step (0.5) on the EDSS or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS). Month 0 is the first dose of fingolimod study drug among all studies in which patient participated. Only descriptive analysis performed.

Part I: Annualized Rates of New or Newly Enlarging T2 Lesions (ARneT2) Compared With First Dose of Fingolimod

Annualized rate of new/newly enlarging T2 lesions (ARneT2) is defined as the number of new or newly enlarging T2 lesions experienced during a specific period of time adjusted to a one-year period. ARneT2 was calculated as follows: (total number of new/newly enlarging T2 lesions) / (total number of days in the study for all patients for that specific period of time) x 365.25.Month 0 is the first dose of fingolimod study drug among all studies in which patient participated. Only descriptive analysis performed.

Part I: Change From First Dose of Fingolimod in Total T2 Lesions Volume

Total volume of T2 lesions was summarized by presenting descriptive statistics for change from first dose of fingolimod baseline values by visit.

Part I: Change From First Dose of Fingolimod in Total T1 Hypointense Lesions Volume

T1 hypointense lesion (black hole) volume was summarized by presenting descriptive statistics for change from first dose of fingolimod baseline values by visit.

Part I: Percent Brain Volume Change (PBVC) Relative to First Dose of Fingolimod

Descriptive statistics on percent brain volume change from first dose of fingolimod baseline were presented by visit. A negative change from baseline indicates improvement.

Part I: Annualized Rate of Brain Atrophy (ARBA) Relative to First Dose of Fingolimod

The annualized rate of brain volume change is an "averaged annual percentage change" in brain volume. ARBA was calculated as: ARBA = [(SIENA/100+1) ^ (365.25/#days)-1]*100 where SIENA=(Vk/V0-1)*100 and Vk is the brain volume at time k, V0 is the brain volume at time 0 and k is the total number of days in the study for all patients for that specific period of time) × 365.25. Only descriptive analysis performed.

Part I: Number of Participants With Confirmed 6-month Disability Progression After First Dose of Fingolimod

Disability progression was defined based on an increase in the EDSS score by 1.5 point for patients with a first dose of fingolimod (FDF) baseline EDSS score of 0, 1 point for patients with FDF baseline EDSS of >=1 and <=5.5, and by 0.5 points for patients with an FDF baseline EDSS>5.5, confirmed after 6 months and all intermediate EDSS assessments. A 6-month confirmed disability progression was defined as a 6-month sustained increase from the reference (potential onset of progression) value in the EDSS scores. i.e., every EDSS score (scheduled or unscheduled) within a 6-month duration after the first progression should meet the progression criteria as specified above. The confirmation could only happen at a scheduled visit and in the absence of a relapse. Only descriptive analysis performed.

Part I: Number of Participants With Categorized Change From First Dose of Fingolimod in Expanded Disability Status Scale (EDSS) Overall Score

The EDSS is a scale for assessing neurological impairment in MS (Kurtzke 1983) including (1) a series of scores in each of eight functional systems, and (2) the EDSS steps (ranging from 0 (normal) to 10 (death due to MS). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Based on the assessment of each FS, the participant's overall score is categorized as Improvement, Stable or Deterioration. If baseline EDSS score is <=5, improvement is indicated by an EDSS score change of <= -1, stable is indicated by an EDSS score change of > -1 and <= 0.5, deterioration is indicated by an EDSS score change of > 0.5; if baseline EDSS score is > 5, improvement is indicated by an EDSS score change of <= -0.5, stable is indicated by an EDSS score change of > -0.5 and <= 0, deterioration is indicated by an EDSS score change of > 0. Only descriptive analysis performed.

Part I: Change From First Dose of Fingolimod in Expanded Disability Status Scale (EDSS)

Full Information

NCT ID

NCT01201356

First Posted

September 10, 2010

Last Updated

March 26, 2021

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01201356

Brief Title

Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis

Official Title

A Single Arm, Open-label, Multicenter Study Evaluating the Long-term Safety and Tolerability of 0.5 mg Fingolimod (FTY720) Administered Orally Once Daily in Patients With Relapsing Forms of Multiple Sclerosis

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

September 13, 2010 (Actual)

Primary Completion Date

October 19, 2018 (Actual)

Study Completion Date

October 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The purpose of this study was to collect long-term safety and tolerability, long-term efficacy, and health outcome data in all patients currently ongoing in the fingolimod multiple sclerosis clinical development program. This study combined all currently ongoing Phase II and III fingolimod extension studies as well as ongoing and newly planned studies into one single long-term extension protocol that provided patients with continuous treatment until fingolimod was registered, commercially available, and reimbursed in the respective countries.

Detailed Description

This study had two parts: Part 1, collecting long-term safety, tolerability, efficacy and health outcomes data through approximately 30-Jun-2016 until all end of study (EOS) visits of Part 1 and last follow-up visit through Jan-2017 and Part 2, collecting limited safety and tolerability data until approximately 30 Jun 2018, in a subset of patients who participated in Part 1, and other eligible patients from ongoing fingolimod trials.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Relapsing Forms of Multiple Sclerosis

Keywords

Fingolimod, FTY720, Relapsing forms of MS, Multiple Sclerosis, Efficacy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

4125 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fingolimod 0.5 mg/day

Arm Type

Experimental

Arm Description

Open-label fingolimod 0.5 mg, taken orally once daily

Intervention Type

Drug

Intervention Name(s)

Fingolimod

Other Intervention Name(s)

FTY720

Intervention Description

0.5 mg/day

Primary Outcome Measure Information:

Title

Parts I and II: Number of Participants With Adverse Events, Serious Adverse Event, and Death

Description

Time Frame

Baseline (Part I) to Month 6 Follow-up (Part II), up to 8 years

Secondary Outcome Measure Information:

Title

Part I: Aggregate Annualized Relapse Rates (ARR) From First Dose of Fingolimod

Description

Time Frame

Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months)

Title

Part I: Number of Participants With Relapses (Confirmed and Unconfirmed) From First Dose of Fingolimod

Description

Time Frame

Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months)

Title

Part I: Annualized Rates of New or Newly Enlarging T2 Lesions (ARneT2) Compared With First Dose of Fingolimod

Description

Time Frame

Month 0 (Core Baseline) to End of Study (an average of Month 156)

Title

Part I: Change From First Dose of Fingolimod in Total T2 Lesions Volume

Description

Total volume of T2 lesions was summarized by presenting descriptive statistics for change from first dose of fingolimod baseline values by visit.

Time Frame

Month 3 to End of Study (Study Completion Visit)

Title

Part I: Change From First Dose of Fingolimod in Total T1 Hypointense Lesions Volume

Description

T1 hypointense lesion (black hole) volume was summarized by presenting descriptive statistics for change from first dose of fingolimod baseline values by visit.

Time Frame

Month 3 to End of Study (Study Completion Visit)

Title

Part I: Percent Brain Volume Change (PBVC) Relative to First Dose of Fingolimod

Description

Descriptive statistics on percent brain volume change from first dose of fingolimod baseline were presented by visit. A negative change from baseline indicates improvement.

Time Frame

Month 3 to Month 156

Title

Part I: Annualized Rate of Brain Atrophy (ARBA) Relative to First Dose of Fingolimod

Description

Time Frame

Month 3 to Month 156

Title

Part I: Number of Participants With Confirmed 6-month Disability Progression After First Dose of Fingolimod

Description

Time Frame

Month 12 to Month 156

Title

Part I: Number of Participants With Categorized Change From First Dose of Fingolimod in Expanded Disability Status Scale (EDSS) Overall Score

Description

Time Frame

Month 3 to Month 6 Follow-up

Title

Part I: Change From First Dose of Fingolimod in Expanded Disability Status Scale (EDSS)

Description

Time Frame

Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: - Patients who have completed selected ongoing or planned trials with FTY720. Key Exclusion Criteria: Premature permanent discontinuation of a previous fingolimod study. Pregnant or nursing (lactating) women. Women of child-bearing potential, UNLESS they are using two birth control methods, at least 1 of which must be hormonal contraception, tubal sterilization, partner's vasectomy or intrauterine device. Chronic disease of the immune system, other than multiple sclerosis, which may require immunosuppressive treatment. Diabetic patients with moderate or severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy and uncontrolled diabetic patients with HbA1c > 8%. Active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis B, Hepatitis C infection or have positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests. Previous treatment with cladribine, cyclophosphamide or mitoxantrone. Treatment with immunoglobulins and/or monoclonal antibodies (including Natalizumab) in the past 3 months during the previous fingolimod study: Any of the following cardiovascular conditions that have developed during the previous fingolimod study: Myocardial infarction within the past 6 months prior to entry in the extension study or with current unstable ischemic heart disease; Cardiac failure (Class III, according to New York Heart Association Classification) or any severe cardiac disease as determined by the investigator; Arrhythmia requiring current treatment with Class III antiarrhythmic drugs (e.g., amiodarone, bretylium, sotalol, ibutilide, azimilide, dofetilide) History or presence of a third degree AV block Proven history of sick sinus syndrome or sino-atrial heart block Known history of angina pectoris due to coronary spasm or Raynaud's phenomenon Any of the following pulmonary conditions during the previous fingolimod study: Severe respiratory disease or pulmonary fibrosis diagnosed (during the previous fingolimod study) Active tuberculosis Alcohol abuse, chronic liver disease during the previous fingolimod study. The patient must have participated in a previous fingolimod trial to be eligible to participate in this trial.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Cullman

State/Province

Alabama

ZIP/Postal Code

35058

Country

United States

Facility Name

Novartis Investigative Site

City

Oceanside

State/Province

California

ZIP/Postal Code

92056

Country

United States

Facility Name

Novartis Investigative Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Facility Name

Novartis Investigative Site

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

Facility Name

Novartis Investigative Site

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Facility Name

Novartis Investigative Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32209

Country

United States

Facility Name

Novartis Investigative Site

City

Maitland

State/Province

Florida

ZIP/Postal Code

32751

Country

United States

Facility Name

Novartis Investigative Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Novartis Investigative Site

City

Sunrise

State/Province

Florida

ZIP/Postal Code

33351

Country

United States

Facility Name

Novartis Investigative Site

City

Tallahassee

State/Province

Florida

ZIP/Postal Code

32308

Country

United States

Facility Name

Novartis Investigative Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33609

Country

United States

Facility Name

Novartis Investigative Site

City

Vero Beach

State/Province

Florida

ZIP/Postal Code

32960

Country

United States

Facility Name

Novartis Investigative Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30327

Country

United States

Facility Name

Novartis Investigative Site

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

Facility Name

Novartis Investigative Site

City

Lenexa

State/Province

Kansas

ZIP/Postal Code

66212

Country

United States

Facility Name

Novartis Investigative Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Facility Name

Novartis Investigative Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Facility Name

Novartis Investigative Site

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64111

Country

United States

Facility Name

Novartis Investigative Site

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

Facility Name

Novartis Investigative Site

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87131-0001

Country

United States

Facility Name

Novartis Investigative Site

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Facility Name

Novartis Investigative Site

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

Novartis Investigative Site

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27607

Country

United States

Facility Name

Novartis Investigative Site

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43614

Country

United States

Facility Name

Novartis Investigative Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

Facility Name

Novartis Investigative Site

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74136

Country

United States

Facility Name

Novartis Investigative Site

City

Tualatin

State/Province

Oregon

ZIP/Postal Code

97062

Country

United States

Facility Name

Novartis Investigative Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

Novartis Investigative Site

City

Bristol

State/Province

Tennessee

ZIP/Postal Code

37620

Country

United States

Facility Name

Novartis Investigative Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37212

Country

United States

Facility Name

Novartis Investigative Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Novartis Investigative Site

City

Burlington

State/Province

Vermont

ZIP/Postal Code

05401

Country

United States

Facility Name

Novartis Investigative Site

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22904

Country

United States

Facility Name

Novartis Investigative Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98122

Country

United States

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

1425

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1181ACH

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1428AQK

Country

Argentina

Facility Name

Novartis Investigative Site

City

Capital Federal

State/Province

Buenos Aires

ZIP/Postal Code

C1192AAW

Country

Argentina

Facility Name

Novartis Investigative Site

City

Guaymallen

State/Province

Mendoza

ZIP/Postal Code

M5507XAD

Country

Argentina

Facility Name

Novartis Investigative Site

City

Ciudad de Salta

State/Province

Provincia De Salta

ZIP/Postal Code

A4406BPF

Country

Argentina

Facility Name

Novartis Investigative Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

2000

Country

Argentina

Facility Name

Novartis Investigative Site

City

San Miguel de Tucumán

State/Province

Tucumán

ZIP/Postal Code

4000

Country

Argentina

Facility Name

Novartis Investigative Site

City

Cordoba

ZIP/Postal Code

X5004CDT

Country

Argentina

Facility Name

Novartis Investigative Site

City

Salta

ZIP/Postal Code

A4400BKZ

Country

Argentina

Facility Name

Novartis Investigative Site

City

Camperdown

State/Province

New South Wales

ZIP/Postal Code

2050

Country

Australia

Facility Name

Novartis Investigative Site

City

Chatswood

State/Province

New South Wales

ZIP/Postal Code

2067

Country

Australia

Facility Name

Novartis Investigative Site

City

Kogarah

State/Province

New South Wales

ZIP/Postal Code

2217

Country

Australia

Facility Name

Novartis Investigative Site

City

Liverpool

State/Province

New South Wales

ZIP/Postal Code

2170

Country

Australia

Facility Name

Novartis Investigative Site

City

North Gosford

State/Province

New South Wales

ZIP/Postal Code

2250

Country

Australia

Facility Name

Novartis Investigative Site

City

Woodville

State/Province

South Australia

ZIP/Postal Code

5011

Country

Australia

Facility Name

Novartis Investigative Site

City

Box Hill

State/Province

Victoria

ZIP/Postal Code

3128

Country

Australia

Facility Name

Novartis Investigative Site

City

Fitzroy

State/Province

Victoria

ZIP/Postal Code

3065

Country

Australia

Facility Name

Novartis Investigative Site

City

Heidelberg

State/Province

Victoria

ZIP/Postal Code

3084

Country

Australia

Facility Name

Novartis Investigative Site

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3050

Country

Australia

Facility Name

Novartis Investigative Site

City

Innsbruck

State/Province

Tyrol

ZIP/Postal Code

6020

Country

Austria

Facility Name

Novartis Investigative Site

City

Linz

ZIP/Postal Code

A-4020

Country

Austria

Facility Name

Novartis Investigative Site

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

Novartis Investigative Site

City

St Poelten

ZIP/Postal Code

3100

Country

Austria

Facility Name

Novartis Investigative Site

City

Vienna

ZIP/Postal Code

1010

Country

Austria

Facility Name

Novartis Investigative Site

City

Vienna

ZIP/Postal Code

1090

Country

Austria

Facility Name

Novartis Investigative Site

City

Aalst

ZIP/Postal Code

9300

Country

Belgium

Facility Name

Novartis Investigative Site

City

Brugge

ZIP/Postal Code

8000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Brussel

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Novartis Investigative Site

City

Bruxelles

ZIP/Postal Code

1070

Country

Belgium

Facility Name

Novartis Investigative Site

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Novartis Investigative Site

City

Charleroi

ZIP/Postal Code

6000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Fraiture En Condroz

ZIP/Postal Code

4557

Country

Belgium

Facility Name

Novartis Investigative Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Melsbroek

ZIP/Postal Code

1820

Country

Belgium

Facility Name

Novartis Investigative Site

City

Pelt

ZIP/Postal Code

3900

Country

Belgium

Facility Name

Novartis Investigative Site

City

Sijsele

ZIP/Postal Code

8340

Country

Belgium

Facility Name

Novartis Investigative Site

City

Sint-Truiden

ZIP/Postal Code

3800

Country

Belgium

Facility Name

Novartis Investigative Site

City

Wilrijk

ZIP/Postal Code

2610

Country

Belgium

Facility Name

Novartis Investigative Site

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90610-000

Country

Brazil

Facility Name

Novartis Investigative Site

City

Rio de Janeiro

State/Province

ZIP/Postal Code

20270-004

Country

Brazil

Facility Name

Novartis Investigative Site

City

Rio de Janeiro

State/Province

ZIP/Postal Code

21941-913

Country

Brazil

Facility Name

Novartis Investigative Site

City

Rio De Janiero

State/Province

ZIP/Postal Code

20221-161

Country

Brazil

Facility Name

Novartis Investigative Site

City

Porto Alegre

State/Province

ZIP/Postal Code

90020-090

Country

Brazil

Facility Name

Novartis Investigative Site

City

Campinas

State/Province

ZIP/Postal Code

13083-970

Country

Brazil

Facility Name

Novartis Investigative Site

City

Ribeirao Preto

State/Province

ZIP/Postal Code

14048-900

Country

Brazil

Facility Name

Novartis Investigative Site

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2G3

Country

Canada

Facility Name

Novartis Investigative Site

City

Burnaby

State/Province

British Columbia

ZIP/Postal Code

V5G 2X6

Country

Canada

Facility Name

Novartis Investigative Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6T 1Z3

Country

Canada

Facility Name

Novartis Investigative Site

City

Victoria

State/Province

British Columbia

ZIP/Postal Code

V8R 1J8

Country

Canada

Facility Name

Novartis Investigative Site

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 2Y9

Country

Canada

Facility Name

Novartis Investigative Site

City

Kingston

State/Province

Ontario

ZIP/Postal Code

K7L 2V7

Country

Canada

Facility Name

Novartis Investigative Site

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5A5

Country

Canada

Facility Name

Novartis Investigative Site

City

Nepean

State/Province

Ontario

ZIP/Postal Code

K2G 6E2

Country

Canada

Facility Name

Novartis Investigative Site

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L6

Country

Canada

Facility Name

Novartis Investigative Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5B 1W8

Country

Canada

Facility Name

Novartis Investigative Site

City

Greenfield Park

State/Province

Quebec

ZIP/Postal Code

J4V 2J2

Country

Canada

Facility Name

Novartis Investigative Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1T 2M4

Country

Canada

Facility Name

Novartis Investigative Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2L 4M1

Country

Canada

Facility Name

Novartis Investigative Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3A 2B4

Country

Canada

Facility Name

Novartis Investigative Site

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H 5N4

Country

Canada

Facility Name

Novartis Investigative Site

City

Regina

State/Province

Saskatchewan

ZIP/Postal Code

S4T 1A5

Country

Canada

Facility Name

Novartis Investigative Site

City

Quebec

ZIP/Postal Code

G1J 1Z4

Country

Canada

Facility Name

Novartis Investigative Site

City

Brno

State/Province

Czech Republic

ZIP/Postal Code

656 91

Country

Czechia

Facility Name

Novartis Investigative Site

City

Olomouc

State/Province

CZE

ZIP/Postal Code

775 20

Country

Czechia

Facility Name

Novartis Investigative Site

City

Ostrava-Poruba

ZIP/Postal Code

708 00

Country

Czechia

Facility Name

Novartis Investigative Site

City

Pardubice

ZIP/Postal Code

532 03

Country

Czechia

Facility Name

Novartis Investigative Site

City

Plzen - Lochotin

ZIP/Postal Code

30460

Country

Czechia

Facility Name

Novartis Investigative Site

City

Prague 5

ZIP/Postal Code

150 00

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha

ZIP/Postal Code

12808

Country

Czechia

Facility Name

Novartis Investigative Site

City

Rychnov nad Kneznou

ZIP/Postal Code

516 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Teplice

ZIP/Postal Code

415 29

Country

Czechia

Facility Name

Novartis Investigative Site

City

Aarhus

ZIP/Postal Code

DK-8000

Country

Denmark

Facility Name

Novartis Investigative Site

City

Copenhagen

ZIP/Postal Code

DK-2100

Country

Denmark

Facility Name

Novartis Investigative Site

City

Alexandria

ZIP/Postal Code

21131

Country

Egypt

Facility Name

Novartis Investigative Site

City

Cairo

ZIP/Postal Code

11566

Country

Egypt

Facility Name

Novartis Investigative Site

City

Cairo

Country

Egypt

Facility Name

Novartis Investigative Site

City

Tallinn

ZIP/Postal Code

10617

Country

Estonia

Facility Name

Novartis Investigative Site

City

Helsinki

ZIP/Postal Code

00930

Country

Finland

Facility Name

Novartis Investigative Site

City

Seinajoki

ZIP/Postal Code

60220

Country

Finland

Facility Name

Novartis Investigative Site

City

Tampere

ZIP/Postal Code

33100

Country

Finland

Facility Name

Novartis Investigative Site

City

Turku

ZIP/Postal Code

20520

Country

Finland

Facility Name

Novartis Investigative Site

City

Nancy

State/Province

Cedex

ZIP/Postal Code

54035

Country

France

Facility Name

Novartis Investigative Site

City

Bordeaux Cedex

ZIP/Postal Code

F-33076

Country

France

Facility Name

Novartis Investigative Site

City

Bron

ZIP/Postal Code

69677

Country

France

Facility Name

Novartis Investigative Site

City

CAEN Cedex

ZIP/Postal Code

14033

Country

France

Facility Name

Novartis Investigative Site

City

Clermont-Ferrand Cedex 1

ZIP/Postal Code

63003

Country

France

Facility Name

Novartis Investigative Site

City

Dijon

ZIP/Postal Code

21034

Country

France

Facility Name

Novartis Investigative Site

City

Lille Cedex

ZIP/Postal Code

59037

Country

France

Facility Name

Novartis Investigative Site

City

Marseille cedex 05

ZIP/Postal Code

13385

Country

France

Facility Name

Novartis Investigative Site

City

Montpellier

ZIP/Postal Code

34295

Country

France

Facility Name

Novartis Investigative Site

City

Nice Cedex 1

ZIP/Postal Code

06602

Country

France

Facility Name

Novartis Investigative Site

City

Paris Cedex 13

ZIP/Postal Code

75651

Country

France

Facility Name

Novartis Investigative Site

City

Poissy

ZIP/Postal Code

78303

Country

France

Facility Name

Novartis Investigative Site

City

Rennes

ZIP/Postal Code

35043

Country

France

Facility Name

Novartis Investigative Site

City

St Herblain

ZIP/Postal Code

44800

Country

France

Facility Name

Novartis Investigative Site

City

Strasbourg Cedex

ZIP/Postal Code

67091

Country

France

Facility Name

Novartis Investigative Site

City

Toulouse cedex 9

ZIP/Postal Code

31059

Country

France

Facility Name

Novartis Investigative Site

City

Ostfildern

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

73760

Country

Germany

Facility Name

Novartis Investigative Site

City

Munich

State/Province

Bavaria

ZIP/Postal Code

81241

Country

Germany

Facility Name

Novartis Investigative Site

City

Regensburg

State/Province

Bavaria

ZIP/Postal Code

93053

Country

Germany

Facility Name

Novartis Investigative Site

City

Koeln

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

50937

Country

Germany

Facility Name

Novartis Investigative Site

City

Aachen

ZIP/Postal Code

52062

Country

Germany

Facility Name

Novartis Investigative Site

City

Aalen

ZIP/Postal Code

73430

Country

Germany

Facility Name

Novartis Investigative Site

City

Abensberg

ZIP/Postal Code

93326

Country

Germany

Facility Name

Novartis Investigative Site

City

Achim

ZIP/Postal Code

28832

Country

Germany

Facility Name

Novartis Investigative Site

City

Alzenau

ZIP/Postal Code

63755

Country

Germany

Facility Name

Novartis Investigative Site

City

Aschaffenburg

ZIP/Postal Code

63739

Country

Germany

Facility Name

Novartis Investigative Site

City

Augsburg

ZIP/Postal Code

86179

Country

Germany

Facility Name

Novartis Investigative Site

City

Bad Honnef

ZIP/Postal Code

53604

Country

Germany

Facility Name

Novartis Investigative Site

City

Bad Krozingen

ZIP/Postal Code

79189

Country

Germany

Facility Name

Novartis Investigative Site

City

Bad Mergentheim

ZIP/Postal Code

97980

Country

Germany

Facility Name

Novartis Investigative Site

City

Bad Neustadt

ZIP/Postal Code

97616

Country

Germany

Facility Name

Novartis Investigative Site

City

Bamberg

ZIP/Postal Code

96049

Country

Germany

Facility Name

Novartis Investigative Site

City

Bamberg

ZIP/Postal Code

96052

Country

Germany

Facility Name

Novartis Investigative Site

City

Bayreuth

ZIP/Postal Code

95445

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10178

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10625

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10713

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10785

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

120999

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

12101

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

12163

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

12351

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13347

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13439

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13507

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

14163

Country

Germany

Facility Name

Novartis Investigative Site

City

Bielefeld

ZIP/Postal Code

33602

Country

Germany

Facility Name

Novartis Investigative Site

City

Bielefeld

ZIP/Postal Code

33611

Country

Germany

Facility Name

Novartis Investigative Site

City

Bielefeld

ZIP/Postal Code

33647

Country

Germany

Facility Name

Novartis Investigative Site

City

Boblingen

ZIP/Postal Code

71032

Country

Germany

Facility Name

Novartis Investigative Site

City

Bochum

ZIP/Postal Code

44787

Country

Germany

Facility Name

Novartis Investigative Site

City

Bochum

ZIP/Postal Code

44789

Country

Germany

Facility Name

Novartis Investigative Site

City

Bochum

ZIP/Postal Code

44892

Country

Germany

Facility Name

Novartis Investigative Site

City

Bogen

ZIP/Postal Code

94327

Country

Germany

Facility Name

Novartis Investigative Site

City

Bonn

ZIP/Postal Code

53111

Country

Germany

Facility Name

Novartis Investigative Site

City

Buchholz in der Nordheide

ZIP/Postal Code

21244

Country

Germany

Facility Name

Novartis Investigative Site

City

Buchholz

ZIP/Postal Code

21244

Country

Germany

Facility Name

Novartis Investigative Site

City

Chemnitz

ZIP/Postal Code

09117

Country

Germany

Facility Name

Novartis Investigative Site

City

Dillingen

ZIP/Postal Code

89407

Country

Germany

Facility Name

Novartis Investigative Site

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Novartis Investigative Site

City

Düsseldorf

ZIP/Postal Code

40211

Country

Germany

Facility Name

Novartis Investigative Site

City

Emden

ZIP/Postal Code

26721

Country

Germany

Facility Name

Novartis Investigative Site

City

Emmendingen

ZIP/Postal Code

79312

Country

Germany

Facility Name

Novartis Investigative Site

City

Erbach

ZIP/Postal Code

64711

Country

Germany

Facility Name

Novartis Investigative Site

City

Erfurt

ZIP/Postal Code

99089

Country

Germany

Facility Name

Novartis Investigative Site

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

Novartis Investigative Site

City

Essen

ZIP/Postal Code

45131

Country

Germany

Facility Name

Novartis Investigative Site

City

Essen

ZIP/Postal Code

45147

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Facility Name

Novartis Investigative Site

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

Novartis Investigative Site

City

Greifswald

ZIP/Postal Code

17475

Country

Germany

Facility Name

Novartis Investigative Site

City

Grevenbroich

ZIP/Postal Code

41515

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20099

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20249

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20354

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

22083

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover

ZIP/Postal Code

30161

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover

ZIP/Postal Code

30171

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Novartis Investigative Site

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Novartis Investigative Site

City

Hennigsdorf

ZIP/Postal Code

16761

Country

Germany

Facility Name

Novartis Investigative Site

City

Herborn

ZIP/Postal Code

35745

Country

Germany

Facility Name

Novartis Investigative Site

City

Homburg

ZIP/Postal Code

66421

Country

Germany

Facility Name

Novartis Investigative Site

City

Ibbenbueren

ZIP/Postal Code

49477

Country

Germany

Facility Name

Novartis Investigative Site

City

Itzehoe

ZIP/Postal Code

25524

Country

Germany

Facility Name

Novartis Investigative Site

City

Jena

ZIP/Postal Code

07743

Country

Germany

Facility Name

Novartis Investigative Site

City

Kaltenkirchen

ZIP/Postal Code

24568

Country

Germany

Facility Name

Novartis Investigative Site

City

Kassel

ZIP/Postal Code

34121

Country

Germany

Facility Name

Novartis Investigative Site

City

Koeln

ZIP/Postal Code

51109

Country

Germany

Facility Name

Novartis Investigative Site

City

Koln

ZIP/Postal Code

50935

Country

Germany

Facility Name

Novartis Investigative Site

City

Krefeld

ZIP/Postal Code

47805

Country

Germany

Facility Name

Novartis Investigative Site

City

Landshut

ZIP/Postal Code

84028

Country

Germany

Facility Name

Novartis Investigative Site

City

Lappersdorf

ZIP/Postal Code

93138

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04275

Country

Germany

Facility Name

Novartis Investigative Site

City

Lohr am Main

ZIP/Postal Code

79816

Country

Germany

Facility Name

Novartis Investigative Site

City

Ludwigshafen

ZIP/Postal Code

67063

Country

Germany

Facility Name

Novartis Investigative Site

City

Magdeburg

ZIP/Postal Code

39120

Country

Germany

Facility Name

Novartis Investigative Site

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Novartis Investigative Site

City

Mannheim

ZIP/Postal Code

68159

Country

Germany

Facility Name

Novartis Investigative Site

City

Marburg

ZIP/Postal Code

35039

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

80331

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

80377

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

81377

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Novartis Investigative Site

City

München

ZIP/Postal Code

81829

Country

Germany

Facility Name

Novartis Investigative Site

City

Nagold

ZIP/Postal Code

72202

Country

Germany

Facility Name

Novartis Investigative Site

City

Neu-Ulm

ZIP/Postal Code

89231

Country

Germany

Facility Name

Novartis Investigative Site

City

Neuburg an der Donau

ZIP/Postal Code

86633

Country

Germany

Facility Name

Novartis Investigative Site

City

Neuruppin

ZIP/Postal Code

16816

Country

Germany

Facility Name

Novartis Investigative Site

City

Oldenburg

ZIP/Postal Code

26122

Country

Germany

Facility Name

Novartis Investigative Site

City

Osnabrück

ZIP/Postal Code

49076

Country

Germany

Facility Name

Novartis Investigative Site

City

Pforzheim

ZIP/Postal Code

75172

Country

Germany

Facility Name

Novartis Investigative Site

City

Potsdam

ZIP/Postal Code

14471

Country

Germany

Facility Name

Novartis Investigative Site

City

Prien

ZIP/Postal Code

83209

Country

Germany

Facility Name

Novartis Investigative Site

City

Rostock

ZIP/Postal Code

18057

Country

Germany

Facility Name

Novartis Investigative Site

City

Ruelzheim

ZIP/Postal Code

76761

Country

Germany

Facility Name

Novartis Investigative Site

City

Rüdersdorf

ZIP/Postal Code

15562

Country

Germany

Facility Name

Novartis Investigative Site

City

Schwarzenbruck

ZIP/Postal Code

90592

Country

Germany

Facility Name

Novartis Investigative Site

City

Schwendi

ZIP/Postal Code

88477

Country

Germany

Facility Name

Novartis Investigative Site

City

Siegen

ZIP/Postal Code

57076

Country

Germany

Facility Name

Novartis Investigative Site

City

Sinsheim

ZIP/Postal Code

74889

Country

Germany

Facility Name

Novartis Investigative Site

City

Stade

ZIP/Postal Code

21682

Country

Germany

Facility Name

Novartis Investigative Site

City

Stuttgart

ZIP/Postal Code

70174

Country

Germany

Facility Name

Novartis Investigative Site

City

Stuttgart

ZIP/Postal Code

70176

Country

Germany

Facility Name

Novartis Investigative Site

City

Stuttgart

ZIP/Postal Code

70178

Country

Germany

Facility Name

Novartis Investigative Site

City

Stuttgart

ZIP/Postal Code

70182

Country

Germany

Facility Name

Novartis Investigative Site

City

Teupitz

ZIP/Postal Code

15755

Country

Germany

Facility Name

Novartis Investigative Site

City

Trier

ZIP/Postal Code

54292

Country

Germany

Facility Name

Novartis Investigative Site

City

Tübingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Novartis Investigative Site

City

Ulm

ZIP/Postal Code

89073

Country

Germany

Facility Name

Novartis Investigative Site

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

Novartis Investigative Site

City

Unterhaching

ZIP/Postal Code

82008

Country

Germany

Facility Name

Novartis Investigative Site

City

Wendlingen

ZIP/Postal Code

73240

Country

Germany

Facility Name

Novartis Investigative Site

City

Wermsdorf

ZIP/Postal Code

04779

Country

Germany

Facility Name

Novartis Investigative Site

City

Wiesbaden

ZIP/Postal Code

65191

Country

Germany

Facility Name

Novartis Investigative Site

City

Wuerzburg

ZIP/Postal Code

97080

Country

Germany

Facility Name

Novartis Investigative Site

City

Wuppertal

ZIP/Postal Code

42283

Country

Germany

Facility Name

Novartis Investigative Site

City

Würzburg

ZIP/Postal Code

97070

Country

Germany

Facility Name

Novartis Investigative Site

City

Alexandroupolis

State/Province

Evros

ZIP/Postal Code

681 00

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

State/Province

ZIP/Postal Code

115 25

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

State/Province

ZIP/Postal Code

115 27

Country

Greece

Facility Name

Novartis Investigative Site

City

Thessaloniki

State/Province

ZIP/Postal Code

570 10

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

106 76

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

115 21

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

11526

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

15123

Country

Greece

Facility Name

Novartis Investigative Site

City

Heraklion Crete

ZIP/Postal Code

711 10

Country

Greece

Facility Name

Novartis Investigative Site

City

Patras

ZIP/Postal Code

265 00

Country

Greece

Facility Name

Novartis Investigative Site

City

Thessaloniki

ZIP/Postal Code

57001

Country

Greece

Facility Name

Novartis Investigative Site

City

Thessaloniki

ZIP/Postal Code

GR 54636

Country

Greece

Facility Name

Novartis Investigative Site

City

Guatemala City

ZIP/Postal Code

01010

Country

Guatemala

Facility Name

Novartis Investigative Site

City

Guatemala City

ZIP/Postal Code

01014

Country

Guatemala

Facility Name

Novartis Investigative Site

City

Budapest

State/Province

HUN

ZIP/Postal Code

1204

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1076

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1085

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1115

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1145

Country

Hungary

Facility Name

Novartis Investigative Site

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Novartis Investigative Site

City

Gyor

ZIP/Postal Code

9024

Country

Hungary

Facility Name

Novartis Investigative Site

City

Miskolc

ZIP/Postal Code

3526

Country

Hungary

Facility Name

Novartis Investigative Site

City

Pecs

ZIP/Postal Code

7623

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szeged

ZIP/Postal Code

6725

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szekesfehervar

ZIP/Postal Code

H-8000

Country

Hungary

Facility Name

Novartis Investigative Site

City

Veszprem

ZIP/Postal Code

H 8200

Country

Hungary

Facility Name

Novartis Investigative Site

City

Dublin 4

ZIP/Postal Code

D04 T6F

Country

Ireland

Facility Name

Novartis Investigative Site

City

Dublin

ZIP/Postal Code

DUBLIN 9

Country

Ireland

Facility Name

Novartis Investigative Site

City

Ashkelon

ZIP/Postal Code

78278

Country

Israel

Facility Name

Novartis Investigative Site

City

Haifa

ZIP/Postal Code

3436212

Country

Israel

Facility Name

Novartis Investigative Site

City

Ramat Gan

ZIP/Postal Code

52621

Country

Israel

Facility Name

Novartis Investigative Site

City

Sefad

ZIP/Postal Code

13100

Country

Israel

Facility Name

Novartis Investigative Site

City

Asti

State/Province

ZIP/Postal Code

14100

Country

Italy

Facility Name

Novartis Investigative Site

City

Acquaviva delle Fonti

State/Province

ZIP/Postal Code

70021

Country

Italy

Facility Name

Novartis Investigative Site

City

Bergamo

State/Province

ZIP/Postal Code

24127

Country

Italy

Facility Name

Novartis Investigative Site

City

Bologna

State/Province

ZIP/Postal Code

40139

Country

Italy

Facility Name

Novartis Investigative Site

City

Montichiari

State/Province

ZIP/Postal Code

25018

Country

Italy

Facility Name

Novartis Investigative Site

City

Cagliari

State/Province

ZIP/Postal Code

09126

Country

Italy

Facility Name

Novartis Investigative Site

City

Chieti

State/Province

ZIP/Postal Code

66100

Country

Italy

Facility Name

Novartis Investigative Site

City

Catania

State/Province

ZIP/Postal Code

95122

Country

Italy

Facility Name

Novartis Investigative Site

City

Catania

State/Province

ZIP/Postal Code

95123

Country

Italy

Facility Name

Novartis Investigative Site

City

Cona

State/Province

ZIP/Postal Code

44100

Country

Italy

Facility Name

Novartis Investigative Site

City

Foggia

State/Province

ZIP/Postal Code

71100

Country

Italy

Facility Name

Novartis Investigative Site

City

Firenze

State/Province

ZIP/Postal Code

50134

Country

Italy

Facility Name

Novartis Investigative Site

City

Genova

State/Province

ZIP/Postal Code

16132

Country

Italy

Facility Name

Novartis Investigative Site

City

Pozzilli

State/Province

ZIP/Postal Code

86077

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

Lazio

ZIP/Postal Code

00168

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20122

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20132

Country

Italy

Facility Name

Novartis Investigative Site

City

Palermo

State/Province

ZIP/Postal Code

90146

Country

Italy

Facility Name

Novartis Investigative Site

City

Fidenza

State/Province

ZIP/Postal Code

43036

Country

Italy

Facility Name

Novartis Investigative Site

City

Pavia

State/Province

ZIP/Postal Code

27100

Country

Italy

Facility Name

Novartis Investigative Site

City

Ravenna

State/Province

ZIP/Postal Code

48100

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00133

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00135

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00161

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00189

Country

Italy

Facility Name

Novartis Investigative Site

City

Siena

State/Province

ZIP/Postal Code

53100

Country

Italy

Facility Name

Novartis Investigative Site

City

Orbassano

State/Province

ZIP/Postal Code

10043

Country

Italy

Facility Name

Novartis Investigative Site

City

Udine

State/Province

ZIP/Postal Code

33100

Country

Italy

Facility Name

Novartis Investigative Site

City

Gallarate

State/Province

ZIP/Postal Code

21013

Country

Italy

Facility Name

Novartis Investigative Site

City

Vicenza

State/Province

ZIP/Postal Code

36100

Country

Italy

Facility Name

Novartis Investigative Site

City

Verona

State/Province

ZIP/Postal Code

37134

Country

Italy

Facility Name

Novartis Investigative Site

City

Viterbo

State/Province

ZIP/Postal Code

01100

Country

Italy

Facility Name

Novartis Investigative Site

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Novartis Investigative Site

City

Napoli

ZIP/Postal Code

80132

Country

Italy

Facility Name

Novartis Investigative Site

City

Napoli

ZIP/Postal Code

80138

Country

Italy

Facility Name

Novartis Investigative Site

City

Irbid

ZIP/Postal Code

22110

Country

Jordan

Facility Name

Novartis Investigative Site

City

Gyeonggi do

State/Province

Korea

ZIP/Postal Code

10408

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Kuala Lumpur

State/Province

Wilayah Persekutuan

ZIP/Postal Code

50586

Country

Malaysia

Facility Name

Novartis Investigative Site

City

Kuala Lumpur

ZIP/Postal Code

59100

Country

Malaysia

Facility Name

Novartis Investigative Site

City

Breda

State/Province

ZIP/Postal Code

4818

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Amsterdam

ZIP/Postal Code

1061 AE

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Amsterdam

ZIP/Postal Code

1081 HV

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Blaricum

ZIP/Postal Code

1261 AN

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Enschede

ZIP/Postal Code

7513 ER

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Gouda

ZIP/Postal Code

2803 HH

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Nieuwegein

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Nijmegen

ZIP/Postal Code

6525 GC

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Rotterdam

ZIP/Postal Code

3015 CE

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Sittard-Geleen

ZIP/Postal Code

6162 BG

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Tilburg

ZIP/Postal Code

5022 GC

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Lillehammer

ZIP/Postal Code

2629

Country

Norway

Facility Name

Novartis Investigative Site

City

Molde

ZIP/Postal Code

6412

Country

Norway

Facility Name

Novartis Investigative Site

City

Stavanger

ZIP/Postal Code

4068

Country

Norway

Facility Name

Novartis Investigative Site

City

Panama City

ZIP/Postal Code

0801

Country

Panama

Facility Name

Novartis Investigative Site

City

Panama City

Country

Panama

Facility Name

Novartis Investigative Site

City

La Perla

State/Province

Callao

ZIP/Postal Code

Country

Peru

Facility Name

Novartis Investigative Site

City

Jesus Maria

State/Province

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Novartis Investigative Site

City

San Isidro

State/Province

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Novartis Investigative Site

City

Bialystok

ZIP/Postal Code

15-276

Country

Poland

Facility Name

Novartis Investigative Site

City

Bialystok

ZIP/Postal Code

15-420

Country

Poland

Facility Name

Novartis Investigative Site

City

Bydgoszcz

ZIP/Postal Code

85 681

Country

Poland

Facility Name

Novartis Investigative Site

City

Gdansk

ZIP/Postal Code

80-803

Country

Poland

Facility Name

Novartis Investigative Site

City

Katowice

ZIP/Postal Code

40 571

Country

Poland

Facility Name

Novartis Investigative Site

City

Katowice

ZIP/Postal Code

40-648

Country

Poland

Facility Name

Novartis Investigative Site

City

Lodz

ZIP/Postal Code

90 324

Country

Poland

Facility Name

Novartis Investigative Site

City

Poznan

ZIP/Postal Code

60-355

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

02-097

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

02-507

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

02-957

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

04141

Country

Poland

Facility Name

Novartis Investigative Site

City

Amadora

ZIP/Postal Code

2720-276

Country

Portugal

Facility Name

Novartis Investigative Site

City

Coimbra

ZIP/Postal Code

3000075

Country

Portugal

Facility Name

Novartis Investigative Site

City

Lisboa

ZIP/Postal Code

1150 314

Country

Portugal

Facility Name

Novartis Investigative Site

City

Porto

ZIP/Postal Code

4099-001

Country

Portugal

Facility Name

Novartis Investigative Site

City

Porto

ZIP/Postal Code

4200 319

Country

Portugal

Facility Name

Novartis Investigative Site

City

Setubal

ZIP/Postal Code

2910-446

Country

Portugal

Facility Name

Novartis Investigative Site

City

Bucharest

ZIP/Postal Code

010825

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucharest

ZIP/Postal Code

011461

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucharest

ZIP/Postal Code

050098

Country

Romania

Facility Name

Novartis Investigative Site

City

Craiova

ZIP/Postal Code

200620

Country

Romania

Facility Name

Novartis Investigative Site

City

Targu Mures

ZIP/Postal Code

540136

Country

Romania

Facility Name

Novartis Investigative Site

City

Samara

State/Province

Samara Region

ZIP/Postal Code

443095

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Ekaterinburg

ZIP/Postal Code

620109

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Kazan

ZIP/Postal Code

420021

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Kazan

ZIP/Postal Code

420097

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

101990

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

121359

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

125367

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

127018

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Nizhny Novgorod

ZIP/Postal Code

603018

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Nizhny Novgorod

ZIP/Postal Code

603155

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint Petersburg

ZIP/Postal Code

194044

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Smolensk

ZIP/Postal Code

214019

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St. Petersburg

ZIP/Postal Code

194291

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St. Petersburg

ZIP/Postal Code

197376

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Bratislava

State/Province

Slovak Republic

ZIP/Postal Code

84103

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Bratislava

ZIP/Postal Code

813 69

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Bratislava

ZIP/Postal Code

826 06

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Martin

ZIP/Postal Code

036 59

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Trnava

ZIP/Postal Code

917 75

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Cape Town

ZIP/Postal Code

7925

Country

South Africa

Facility Name

Novartis Investigative Site

City

Durban

Country

South Africa

Facility Name

Novartis Investigative Site

City

Rosebank

ZIP/Postal Code

2196

Country

South Africa

Facility Name

Novartis Investigative Site

City

Malaga

State/Province

Andalucia

ZIP/Postal Code

29010

Country

Spain

Facility Name

Novartis Investigative Site

City

Sevilla

State/Province

Andalucia

ZIP/Postal Code

41009

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08035

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08036

Country

Spain

Facility Name

Novartis Investigative Site

City

L Hospitalet De Llobregat

State/Province

Catalunya

ZIP/Postal Code

08907

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

46010

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

46026

Country

Spain

Facility Name

Novartis Investigative Site

City

Santiago de Compostela

State/Province

Galicia

ZIP/Postal Code

15706

Country

Spain

Facility Name

Novartis Investigative Site

City

Bilbao

State/Province

Pais Vasco

ZIP/Postal Code

48013

Country

Spain

Facility Name

Novartis Investigative Site

City

San Sebastian

State/Province

Pais Vasco

ZIP/Postal Code

20080

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

ZIP/Postal Code

08041

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28222

Country

Spain

Facility Name

Novartis Investigative Site

City

Santa Cruz de Tenerife

ZIP/Postal Code

38009

Country

Spain

Facility Name

Novartis Investigative Site

City

Goeteborg

ZIP/Postal Code

413 45

Country

Sweden

Facility Name

Novartis Investigative Site

City

Linkoping

ZIP/Postal Code

SE 581 85

Country

Sweden

Facility Name

Novartis Investigative Site

City

Stockholm

ZIP/Postal Code

102 35

Country

Sweden

Facility Name

Novartis Investigative Site

City

Stockholm

ZIP/Postal Code

14186

Country

Sweden

Facility Name

Novartis Investigative Site

City

Umea

ZIP/Postal Code

901 85

Country

Sweden

Facility Name

Novartis Investigative Site

City

Aarau

ZIP/Postal Code

5001

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Carouge

ZIP/Postal Code

1227

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Lausanne

ZIP/Postal Code

1011

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Lugano

ZIP/Postal Code

6900

Country

Switzerland

Facility Name

Novartis Investigative Site

City

St Gallen

ZIP/Postal Code

9007

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Zuerich

ZIP/Postal Code

8091

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Istanbul

State/Province

TUR

ZIP/Postal Code

34098

Country

Turkey

Facility Name

Novartis Investigative Site

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Novartis Investigative Site

City

Ankara

ZIP/Postal Code

06500

Country

Turkey

Facility Name

Novartis Investigative Site

City

Antalya

ZIP/Postal Code

07070

Country

Turkey

Facility Name

Novartis Investigative Site

City

Gaziantep

ZIP/Postal Code

27310

Country

Turkey

Facility Name

Novartis Investigative Site

City

Haseki / Istanbul

ZIP/Postal Code

34096

Country

Turkey

Facility Name

Novartis Investigative Site

City

Istanbul

ZIP/Postal Code

34093

Country

Turkey

Facility Name

Novartis Investigative Site

City

Istanbul

ZIP/Postal Code

34147

Country

Turkey

Facility Name

Novartis Investigative Site

City

Istanbul

ZIP/Postal Code

34722

Country

Turkey

Facility Name

Novartis Investigative Site

City

Izmir

ZIP/Postal Code

35040

Country

Turkey

Facility Name

Novartis Investigative Site

City

Izmir

ZIP/Postal Code

35340

Country

Turkey

Facility Name

Novartis Investigative Site

City

Mersin

ZIP/Postal Code

33079

Country

Turkey

Facility Name

Novartis Investigative Site

City

Samsun

ZIP/Postal Code

55139

Country

Turkey

Facility Name

Novartis Investigative Site

City

Trabzon

ZIP/Postal Code

61080

Country

Turkey

Facility Name

Novartis Investigative Site

City

Yenisehir / Izmir

Country

Turkey

Facility Name

Novartis Investigative Site

City

Truro

State/Province

Cornwall

ZIP/Postal Code

TR1 3LJ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Brighton

State/Province

East Sussex

ZIP/Postal Code

BN2 5BE

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Salford

State/Province

Manchester

ZIP/Postal Code

M6 8HD

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Headington

State/Province

Oxfordshire

ZIP/Postal Code

OX3 9DU

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Sheffield

State/Province

South Yorkshire

ZIP/Postal Code

S10 2JF

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Stoke on Trent

State/Province

Staffordshire

ZIP/Postal Code

ST46QG

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Birmingham

ZIP/Postal Code

B15 2TH

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Bristol

ZIP/Postal Code

BS10 5NB

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Dundee

ZIP/Postal Code

DD1 9SY

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Edinburgh

ZIP/Postal Code

EH4 2XU

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Essex

ZIP/Postal Code

RM7 0BE

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Great Yarmouth

ZIP/Postal Code

NR31 6LA

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Liverpool

ZIP/Postal Code

L9 7LJ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

SE22 8PT

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

SW17 0QT

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

W8 6RF

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Middlesbrough

ZIP/Postal Code

TS4 3BW

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Newcastle Upon Tyne

ZIP/Postal Code

NE1 4LP

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Northampton

ZIP/Postal Code

NN1 5BD

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Nottingham

ZIP/Postal Code

NG7 2UH

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Poole

ZIP/Postal Code

BH15 2JB

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Swindon

ZIP/Postal Code

SN3 6BB

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

IPD Sharing URL

https://www.clinicalstudydatarequest.com

Citations:

PubMed Identifier

31598139

Citation

Cohen JA, Tenenbaum N, Bhatt A, Zhang Y, Kappos L. Extended treatment with fingolimod for relapsing multiple sclerosis: the 14-year LONGTERMS study results. Ther Adv Neurol Disord. 2019 Sep 25;12:1756286419878324. doi: 10.1177/1756286419878324. eCollection 2019.

Results Reference

derived

Learn more about this trial

Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis

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Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis

Relapsing Forms of Multiple Sclerosis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial