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Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Interferon beta-1a
Fingolimod
Placebo capsule
Placebo i.m. injection
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring pediatric, multiple sclerosis, fingolimod, pre-pubertal, low weight, children, adolescent, MS, core phase, extension phase, younger cohort

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria Core Phase:

  • diagnosis of multiple sclerosis
  • at least one MS relapse during the previous year or two MS relapses in the previous 2 years or evidence of Gd enhancing lesions on MRI within 6 months EDSS score of 0 to 5.5, inclusive

Key Exclusion Criteria Core Phase:

  • patients with progressive MS
  • patients with an active, chronic disease of the immune system other than MS
  • patients meeting the definition of ADEM
  • patients with severe cardiac disease or significant findings on the screening ECG.
  • patients with severe renal insufficiency

Key Inclusion Criteria Extension Phase:

Applies to all patients participating in the Core Phase and then entering the Extension Phase. 1. Patients that originally met Core Phase Inclusion criteria and completed the Core phase on or off of study drug.

Applies to patients newly recruited to participate in the Extension Phase.

  • All newly recruited patients' that enroll directly into the Extension Phase must fulfill the local country health authority product label approved for pediatric age group for inclusion criteria.
  • Central review (including initial MRI report) of the diagnosis of pediatric MS will be required for all newly recruited patients.

Key Exclusion Criteria Extension Phase:

Applies to patients who completed the Core Phase, but prematurely discontinued study drug.

  1. Premature discontinuation of the study drug during the Core Phase due to:

    • an adverse event,
    • serious adverse event,
    • laboratory abnormality
    • other conditions leading to permanent study drug discontinuation due to safety reasons
  2. Patients with known new events or concomitant medications (washout periods required prior to Visit 15) that would exclude them from the Core Phase exclusion criteria. Serological or other additional tests will not be required.

Applies to patients newly recruited in the younger cohort to participate in the Extension Phase.

1. All newly recruited patients in the younger cohort that enroll directly into the Extension Phase must fulfill the exclusion criteria for the core phase.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative Site
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative Site
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative Site
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative Site
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Fingolimod

Interferon beta-1a

Fingolimod-Younger Cohort

Arm Description

Fingolimod was administered orally once daily at a dose of either 0.5 mg or 0.25 mg (depending on patient's body weight) with the aim to achieve systemic exposure in range of that in adults at the licensed 0.5 mg dose. Participants in this arm during core continued into extension and received open-label treatment

An intramuscular (IM) injection of Interferon beta-1a was administered once weekly during core phase. Participants switched to receive open-label fingolimod in extension phase

The 'younger cohort' refers to the new pediatric patients to be recruited in the extension phase who fulfill any single one or a combination of the following criteria: being ≤12 years of age, or weighing ≤40 kg, or being prepubertal (i.e. pubertal status of Tanner stage <2)

Outcomes

Primary Outcome Measures

Frequency of Relapses in Patients Treated for up to 24 Months
Frequency of relapses assessed by the annualized relapse rate (ARR). The ARR is defined as the average number of confirmed relapses per year (total number of confirmed relapses divided by the total days in the study multiplied by 365.25).

Secondary Outcome Measures

New/Newly Enlarged T2 Lesions
Annualized rate of the number of new/newly enlarged T2 lesions up to Month 24
Time to First Relapse
Time to first relapse was determined.
Proportion of Patients Relapse-free
Proportion of patients relapse-free was determined
T1 Gd- Enhancing Lesions
Number of T1 Gd-enhancing lesions per scan up to Month 24
Pharmacokinetics (Cavg) of Fingolimod-P
Cavg (average drug concentration over the dose interval) will be evaluated.
Pharmacokinetic/Pharmacodynamic Relationship for Fingolimod-P to Lymphocyte Levels
Population PK/PD modeling approaches were used to relate the individual fingolimod-P concentrations to lymphocyte counts.

Full Information

First Posted
May 8, 2013
Last Updated
October 16, 2023
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01892722
Brief Title
Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis
Official Title
A 2 Year, Double-blind, Randomized, Multicenter, Active-controlled Core Phase to Evaluate Safety & Efficacy of Daily Fingolimod vs Weekly Interferon β-1a im in Pediatric Patients With Multiple Sclerosis and 5 Year Fingolimod Extension Phase
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 26, 2013 (Actual)
Primary Completion Date
July 14, 2017 (Actual)
Study Completion Date
July 12, 2029 (Anticipated)

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
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the safety and efficacy of fingolimod vs. interferon beta-1a i.m. in pediatric patients with multiple sclerosis (MS)
Detailed Description
The study is divided into a Core Phase, which includes the Double-Blind Treatment Period, and an Extension Phase in which all patients will be treated with fingolimod. The Core Phase is a 24-month, double-blind, randomized, active-controlled, parallel-group multicenter study phase to evaluate the efficacy and safety of fingolimod compared to IFN β-1a in children/adolescent patients aged 10-17 years old with MS. The Extension Phase is a 60-month (5 year) study phase for patients who complete the Core Phase of the study and meet all inclusion/exclusion criteria and for patients who will be recruited in the younger cohort to participate in the Extension Phase. The 'younger cohort' refers to the population of pediatric patients fulfilling any single one or a combination of the following criteria: being ≤12 years of age, or weighing ≤40 kg, or being prepubertal (i.e. pubertal status of Tanner stage <2). The recruitment of the younger cohort (up to 25 patients) was requested as a post- approval health authority commitment

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
pediatric, multiple sclerosis, fingolimod, pre-pubertal, low weight, children, adolescent, MS, core phase, extension phase, younger cohort

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
There are 2 arms in the core phase. In the extension phase all participants are receiving open-label.study drug. A third arm has been added to enroll up to 25 new younger patients per HA post approval commitment.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fingolimod
Arm Type
Experimental
Arm Description
Fingolimod was administered orally once daily at a dose of either 0.5 mg or 0.25 mg (depending on patient's body weight) with the aim to achieve systemic exposure in range of that in adults at the licensed 0.5 mg dose. Participants in this arm during core continued into extension and received open-label treatment
Arm Title
Interferon beta-1a
Arm Type
Active Comparator
Arm Description
An intramuscular (IM) injection of Interferon beta-1a was administered once weekly during core phase. Participants switched to receive open-label fingolimod in extension phase
Arm Title
Fingolimod-Younger Cohort
Arm Type
Experimental
Arm Description
The 'younger cohort' refers to the new pediatric patients to be recruited in the extension phase who fulfill any single one or a combination of the following criteria: being ≤12 years of age, or weighing ≤40 kg, or being prepubertal (i.e. pubertal status of Tanner stage <2)
Intervention Type
Drug
Intervention Name(s)
Interferon beta-1a
Intervention Description
Administration once weekly via i.m. injections.
Intervention Type
Drug
Intervention Name(s)
Fingolimod
Intervention Description
Administrated orally once daily: 0.5 mg capsule for patients over 40 kg or 0.25 mg capsule for patients 40 kg or less.
Intervention Type
Drug
Intervention Name(s)
Placebo capsule
Intervention Description
Matching placebo capsule required for double-dummy masking to blind formulations.
Intervention Type
Drug
Intervention Name(s)
Placebo i.m. injection
Intervention Description
Matching placebo i.m. injection required for double-dummy masking to blind formulations.
Primary Outcome Measure Information:
Title
Frequency of Relapses in Patients Treated for up to 24 Months
Description
Frequency of relapses assessed by the annualized relapse rate (ARR). The ARR is defined as the average number of confirmed relapses per year (total number of confirmed relapses divided by the total days in the study multiplied by 365.25).
Time Frame
24 months
Secondary Outcome Measure Information:
Title
New/Newly Enlarged T2 Lesions
Description
Annualized rate of the number of new/newly enlarged T2 lesions up to Month 24
Time Frame
24 months
Title
Time to First Relapse
Description
Time to first relapse was determined.
Time Frame
24 months
Title
Proportion of Patients Relapse-free
Description
Proportion of patients relapse-free was determined
Time Frame
24 months
Title
T1 Gd- Enhancing Lesions
Description
Number of T1 Gd-enhancing lesions per scan up to Month 24
Time Frame
24 months
Title
Pharmacokinetics (Cavg) of Fingolimod-P
Description
Cavg (average drug concentration over the dose interval) will be evaluated.
Time Frame
24 months
Title
Pharmacokinetic/Pharmacodynamic Relationship for Fingolimod-P to Lymphocyte Levels
Description
Population PK/PD modeling approaches were used to relate the individual fingolimod-P concentrations to lymphocyte counts.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria Core Phase: diagnosis of multiple sclerosis at least one MS relapse during the previous year or two MS relapses in the previous 2 years or evidence of Gd enhancing lesions on MRI within 6 months EDSS score of 0 to 5.5, inclusive Key Exclusion Criteria Core Phase: patients with progressive MS patients with an active, chronic disease of the immune system other than MS patients meeting the definition of ADEM patients with severe cardiac disease or significant findings on the screening ECG. patients with severe renal insufficiency Key Inclusion Criteria Extension Phase: Applies to all patients participating in the Core Phase and then entering the Extension Phase. 1. Patients that originally met Core Phase Inclusion criteria and completed the Core phase on or off of study drug. Applies to patients newly recruited to participate in the Extension Phase. All newly recruited patients' that enroll directly into the Extension Phase must fulfill the local country health authority product label approved for pediatric age group for inclusion criteria. Central review (including initial MRI report) of the diagnosis of pediatric MS will be required for all newly recruited patients. Key Exclusion Criteria Extension Phase: Applies to patients who completed the Core Phase, but prematurely discontinued study drug. Premature discontinuation of the study drug during the Core Phase due to: an adverse event, serious adverse event, laboratory abnormality other conditions leading to permanent study drug discontinuation due to safety reasons Patients with known new events or concomitant medications (washout periods required prior to Visit 15) that would exclude them from the Core Phase exclusion criteria. Serological or other additional tests will not be required. Applies to patients newly recruited in the younger cohort to participate in the Extension Phase. 1. All newly recruited patients in the younger cohort that enroll directly into the Extension Phase must fulfill the exclusion criteria for the core phase.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
1-888-669-6682
Email
Novartis.email@novartis.com
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
+41613241111
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
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32312
Country
United States
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-9500
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104 4399
Country
United States
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Minsk
ZIP/Postal Code
220114
Country
Belarus
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30150 221
Country
Brazil
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
20270-004
Country
Brazil
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-000
Country
Brazil
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Goiania
ZIP/Postal Code
74605 020
Country
Brazil
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Individual Site Status
Terminated
Facility Name
Novartis Investigative Site
City
Bordeaux Cedex
ZIP/Postal Code
33076
Country
France
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Le Kremlin Bicetre
ZIP/Postal Code
94275
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Marseille Cedex 05
ZIP/Postal Code
13885
Country
France
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Toulouse Cedex
ZIP/Postal Code
31059
Country
France
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Bonn
ZIP/Postal Code
53111
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Essen
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Gottingen
ZIP/Postal Code
37075
Country
Germany
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Muenchen
ZIP/Postal Code
80337
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Bari
State/Province
BA
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Terminated
Facility Name
Novartis Investigative Site
City
Montichiari
State/Province
BS
ZIP/Postal Code
25018
Country
Italy
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Catania
State/Province
CT
ZIP/Postal Code
95123
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Cefalu
State/Province
PA
ZIP/Postal Code
90015
Country
Italy
Individual Site Status
Terminated
Facility Name
Novartis Investigative Site
City
Roma
State/Province
RM
ZIP/Postal Code
00133
Country
Italy
Individual Site Status
Terminated
Facility Name
Novartis Investigative Site
City
Roma
State/Province
RM
ZIP/Postal Code
00189
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Gallarate
State/Province
VA
ZIP/Postal Code
21013
Country
Italy
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Riga
ZIP/Postal Code
LV-1004
Country
Latvia
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Kaunas
State/Province
LTU
ZIP/Postal Code
LT 50161
Country
Lithuania
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Ciudad De Mexico
State/Province
D F
ZIP/Postal Code
06700
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
03310
Country
Mexico
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
04530
Country
Mexico
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06720
Country
Mexico
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Merida
State/Province
Yucatán
ZIP/Postal Code
97125
Country
Mexico
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Rotterdam
ZIP/Postal Code
3015 CN
Country
Netherlands
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Lodz
ZIP/Postal Code
93-338
Country
Poland
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Lublin
ZIP/Postal Code
20-093
Country
Poland
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Poznan
ZIP/Postal Code
60-355
Country
Poland
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Wroclaw
ZIP/Postal Code
50 420
Country
Poland
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Santurce
ZIP/Postal Code
00912
Country
Puerto Rico
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Bucuresti
ZIP/Postal Code
041914
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kazan
ZIP/Postal Code
420043
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
119602
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Novosibirsk
ZIP/Postal Code
630087
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
St. Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bratislava
State/Province
Slovensko
ZIP/Postal Code
83340
Country
Slovakia
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Malaga
State/Province
Andalucia
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sevilla
State/Province
Andalucia
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Esplugues De Llobregat
State/Province
Barcelona
ZIP/Postal Code
08950
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Barakaldo
State/Province
Pais Vasco
ZIP/Postal Code
48903
Country
Spain
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36212
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Konak-Izmir
State/Province
Izmir
ZIP/Postal Code
35210
Country
Turkey
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Istanbul
State/Province
TUR
ZIP/Postal Code
34098
Country
Turkey
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Cherkasy
ZIP/Postal Code
18000
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Dnipropetrovsk
ZIP/Postal Code
49027
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kharkiv
ZIP/Postal Code
61091
Country
Ukraine
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Kiev
ZIP/Postal Code
03110
Country
Ukraine
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Odesa
ZIP/Postal Code
65009
Country
Ukraine
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Vinnytsa
ZIP/Postal Code
21029
Country
Ukraine
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
West Midlands
State/Province
Birmingham
ZIP/Postal Code
B4 6NH
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Edinburgh
ZIP/Postal Code
EH9 1LF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
London
ZIP/Postal Code
WC1N 1EH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
London
ZIP/Postal Code
WC1N 3BG
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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
Citations:
PubMed Identifier
31467033
Citation
Deiva K, Huppke P, Banwell B, Chitnis T, Gartner J, Krupp L, Waubant E, Stites T, Pearce GL, Merschhemke M. Consistent control of disease activity with fingolimod versus IFN beta-1a in paediatric-onset multiple sclerosis: further insights from PARADIGMS. J Neurol Neurosurg Psychiatry. 2020 Jan;91(1):58-66. doi: 10.1136/jnnp-2019-321124. Epub 2019 Aug 29.
Results Reference
derived
PubMed Identifier
30207920
Citation
Chitnis T, Arnold DL, Banwell B, Bruck W, Ghezzi A, Giovannoni G, Greenberg B, Krupp L, Rostasy K, Tardieu M, Waubant E, Wolinsky JS, Bar-Or A, Stites T, Chen Y, Putzki N, Merschhemke M, Gartner J; PARADIGMS Study Group. Trial of Fingolimod versus Interferon Beta-1a in Pediatric Multiple Sclerosis. N Engl J Med. 2018 Sep 13;379(11):1017-1027. doi: 10.1056/NEJMoa1800149.
Results Reference
derived
Links:
URL
https://www.nationalmssociety.org/Research/Participate-in-Research-Studies/Participate-in-Clinical-Trials
Description
Recruitment website

Learn more about this trial

Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis

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