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A 6-month, Randomized, Open-label, Patient OutComes, Safety and Tolerability Study of Fingolimod (FTY720) 0.5 mg/Day vs. Comparator in Patients With Relapsing Forms of Multiple Sclerosis (EPOC)

Primary Purpose

Relapsing Forms of Multiple Sclerosis

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Fingolimod

Standard MS DMTs

About this trial

This is an interventional treatment trial for Relapsing Forms of Multiple Sclerosis focused on measuring Relapsing Forms of Multiple Sclerosis, Disease Modifying Therapy, fingolimod, Patient Reported Outcomes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Relapsing forms of MS
Expanded Disability Status Scale (EDSS) 0-5.5
Continuous treatment with MS DMT for a minimum of 6 months
Fingolimod naive

Exclusion Criteria:

Immune system diseases other than MS
Active macular edema
History of selected prior infections and criteria for immunizations
History of selected immune system treatments and/or medications
Selected cardiovascular, pulmonary, or hepatic conditions
Selected abnormal laboratory values
Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria applied

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fingolimod

Multiple Sclerosis Disease Modifying Treatments (MS DMTs)

Arm Description

Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period .

Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.

Outcomes

Primary Outcome Measures

Change From Baseline in the Global Satisfaction Subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM) at Month 6

The TSQM was developed and validated as a general measure for treatment satisfaction. It contains 14 items assessing the following 4 domains: effectiveness (sum of scores for questions 1 - 3), side effects (sum of scores for questions 4 - 8), convenience (sum of scores for questions 9 - 11) and Global Satisfaction (sum of scores for questions 12 - 14). The primary analysis was on Global Satisfaction. Question 12 scored as 1(not at all confident) to 5 (extremely confident); question 13 scored as 1(not at all certain) to 5(extremely certain); and question 14 scored as 1(extremely dissatisfied) to 7(extremely satisfied). The scores of the domain were added together and an algorithm was used to create a score of 0 to 100. Higher scores indicated greater satisfaction. A positive change from baseline indicates improvement.

Secondary Outcome Measures

Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death

In this analysis, patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.

Change From Baseline in Patient-reported Activities of Daily Living (ADL) Using the Multiple Sclerosis Activities Scale (PRIMUS-Activities) at Month 6

The PRIMUS activity measure is a 15-item assessment of patient-reported ADL. The PRIMUS-Activities total score was calculated by summing the 15 item scores after recoding the responses from 1 - 3 to 0 - 2. Totals scores range from 0 to 30 with higher scores indicating greater activity limitation. If no more than 20% of the items were missing, the total score was the product of the mean response of the non-missing items and the total number of items. If more than 20% of all items were missing, the total score was set to missing. A negative change from baseline indicates improvement.

Change From Baseline in Patient-reported Fatigue Using the Fatigue Severity Scale (FSS)

The Fatigue Severity Scale (FSS) is a 9-item assessment scale measuring fatigue and its effects, using a scale from 1 to 7, with higher scores indicating greater fatigue, or greater negative effects of fatigue on daily living. The FSS 9 item total score was calculated by summing the first 9 item scores and dividing by the number of non-missing items. If no more than 20% of the items were missing, the total score was the product of the mean response of the non missing items and the total number of items. If more than 20% of all items were missing, the total score was set to missing. A negative change from baseline indicates improvement.

Change From Baseline in the Patient-reported Effectiveness Subscale Using the TSQM v1.4

The effectiveness scale was scored as follows: 1(extremely dissatisfied) to 7(extremely satisfied). The scores of the domain were added together and an algorithm was used to create a score of 0 to 100. Higher scores indicated greater satisfaction. A positive change from baseline indicates improvement.

Change From Baseline in the Patient-reported Side Effects Subscale Using the TSQM v1.4

The Side Effects subscale was scored as follows: question 4 scored as 0(no) or 1(yes); question 5 scored as 1(extremely bothersome) to 5(not at all bothersome); and questions 6 - 8 scored as 1(a great deal) to 5(not at all). The scores of the domain were added together and an algorithm was used to create a score of 0 to 100. Higher scores indicated greater satisfaction. A positive change from baseline indicates improvement.

Change From Baseline in the Patient-reported Convenience Subscale Using the TSQM v1.4

The convenience subscale was scored as follows: questions 9 and 10 scored as 1(extremely difficult) to 7 (extremely easy), and question 11 scored as 1(extremely inconvenient) to 7 (extremely convenient). The scores of the domain were added together and an algorithm was used to create a score of 0 to 100. Higher scores indicated greater satisfaction. A positive change from baseline indicates improvement.

Change From Baseline in Patient-reported Health-related Quality-of-life Using the Short Form Health Survey v2 Standard (SF-36 v2)

The SF-36v2 is a validated health-related quality of life instrument used in numerous disease states, including MS. It is a self-administered survey that measures 8 domains of health including: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems and general mental health. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). If half or more questions within a domain were answered, then a score was calculated for that domain. Otherwise, the patient score for that domain was set to missing. If the patient was missing any 1 of the 8 scale scores, then the physical and mental component scores were set to missing. An algorithm was used to create a score from 0 to 100 for each domain score and component score. A positive change from baseline indicates improvement.

Change From Baseline in Patient-reported Depression Using the Beck Depression Inventory (BDI-II)

The Beck Depression Inventory (BDI-II) is a 21-question multiple-choice self-report inventory. Each item is scored from 0 to 3. The questions in the BDI-II refer to how the patient has been feeling over the past two weeks specifically. The BDI-II total score was calculated by summing the 21 item scores. Final scores ranged from 0 to 63 where higher scores indicated more severe depression. If no more than 20% of the items were missing, the total score was the product of the mean response of the non-missing items and the total number of items. If more than 20% of all items were missing, the total score was set to missing. A negative change indicates improvement.

Physician-reported Clinical Global Impression of Improvement (CGI-I)

The CGI-I is a rating scale allowing a physician-reported global evaluation of the subject's improvement over time. The Investigator assessed the subject's clinical change relative to the symptoms at baseline on the CGI-I, a seven-point scale, with rating as follows: 1=Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, 7=Very much worse. The assessments were completed at Month 3 and Month 6. A lower score indicates improvement.

Full Information

NCT ID

NCT01216072

First Posted

September 7, 2010

Last Updated

January 14, 2014

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01216072

Brief Title

A 6-month, Randomized, Open-label, Patient OutComes, Safety and Tolerability Study of Fingolimod (FTY720) 0.5 mg/Day vs. Comparator in Patients With Relapsing Forms of Multiple Sclerosis

Acronym

EPOC

Official Title

A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient OutComes, Safety and Tolerability of Fingolimod (FTY720) 0.5 mg/Day in Patients With Relapsing Forms of Multiple Sclerosis Who Are Candidates for MS Therapy Change From Previous Disease Modifying Therapy (EPOC)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

August 2010 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to evaluate the change in patient-reported outcomes, physician assessment of a change as well as safety and tolerability in patients with Relapsing Forms of Multiple Sclerosis on previous Disease Modifying Therapy (DMT) who are randomized to one of two treatment arms: fingolimod vs. standard of care DMT.

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

Relapsing Forms of Multiple Sclerosis, Disease Modifying Therapy, fingolimod, Patient Reported Outcomes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1053 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fingolimod

Arm Type

Experimental

Arm Description

Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period .

Arm Title

Multiple Sclerosis Disease Modifying Treatments (MS DMTs)

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Fingolimod

Other Intervention Name(s)

GILENYA™

Intervention Description

0.5 mg/day oral capsule

Intervention Type

Drug

Intervention Name(s)

Standard MS DMTs

Other Intervention Name(s)

Avonex®,, Copaxone®,, Rebif®,, Betaseron®,, Extavia®

Primary Outcome Measure Information:

Title

Change From Baseline in the Global Satisfaction Subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM) at Month 6

Description

Time Frame

Baseline, Month 6

Secondary Outcome Measure Information:

Title

Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death

Description

In this analysis, patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.

Time Frame

9 months (6 month core + 3 month Extension)

Title

Change From Baseline in Patient-reported Activities of Daily Living (ADL) Using the Multiple Sclerosis Activities Scale (PRIMUS-Activities) at Month 6

Description

Time Frame

Baseline, Month 6

Title

Change From Baseline in Patient-reported Fatigue Using the Fatigue Severity Scale (FSS)

Description

Time Frame

Baseline, Month 3, Month 6

Title

Change From Baseline in the Patient-reported Effectiveness Subscale Using the TSQM v1.4

Description

Time Frame

Baseline, Month 6

Title

Change From Baseline in the Patient-reported Side Effects Subscale Using the TSQM v1.4

Description

Time Frame

Baseline, Month 6

Title

Change From Baseline in the Patient-reported Convenience Subscale Using the TSQM v1.4

Description

Time Frame

Baseline, Month 6

Title

Change From Baseline in Patient-reported Health-related Quality-of-life Using the Short Form Health Survey v2 Standard (SF-36 v2)

Description

Time Frame

Baseline, Month 6

Title

Change From Baseline in Patient-reported Depression Using the Beck Depression Inventory (BDI-II)

Description

Time Frame

Baseline, Month 3, Month 6

Title

Physician-reported Clinical Global Impression of Improvement (CGI-I)

Description

Time Frame

Month 3, Month 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Relapsing forms of MS Expanded Disability Status Scale (EDSS) 0-5.5 Continuous treatment with MS DMT for a minimum of 6 months Fingolimod naive Exclusion Criteria: Immune system diseases other than MS Active macular edema History of selected prior infections and criteria for immunizations History of selected immune system treatments and/or medications Selected cardiovascular, pulmonary, or hepatic conditions Selected abnormal laboratory values Pregnant or nursing women Other protocol-defined inclusion/exclusion criteria applied

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

35209

Country

United States

Facility Name

Novartis Investigative Site

City

Cullman

State/Province

Alabama

ZIP/Postal Code

35058

Country

United States

Facility Name

Novartis Investigative Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85004

Country

United States

Facility Name

Novartis Investigative Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85006

Country

United States

Facility Name

Novartis Investigative Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85013

Country

United States

Facility Name

Novartis Investigative Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85032

Country

United States

Facility Name

Novartis Investigative Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85741

Country

United States

Facility Name

Novartis Investigative Site

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

Novartis Investigative Site

City

Berkeley

State/Province

California

ZIP/Postal Code

94705

Country

United States

Facility Name

Novartis Investigative Site

City

Fresno

State/Province

California

ZIP/Postal Code

93710

Country

United States

Facility Name

Novartis Investigative Site

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Facility Name

Novartis Investigative Site

City

La Habra

State/Province

California

ZIP/Postal Code

90631

Country

United States

Facility Name

Novartis Investigative Site

City

Loma Linda

State/Province

California

ZIP/Postal Code

92354

Country

United States

Facility Name

Novartis Investigative Site

City

Newport Beach

State/Province

California

ZIP/Postal Code

92660

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

Walnut Creek

State/Province

California

ZIP/Postal Code

94598

Country

United States

Facility Name

Novartis Investigative Site

City

Boulder

State/Province

Colorado

ZIP/Postal Code

80304

Country

United States

Facility Name

Novartis Investigative Site

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80920

Country

United States

Facility Name

Novartis Investigative Site

City

Fort Collins

State/Province

Colorado

ZIP/Postal Code

80528

Country

United States

Facility Name

Novartis Investigative Site

City

Fairfield

State/Province

Connecticut

ZIP/Postal Code

06824

Country

United States

Facility Name

Novartis Investigative Site

City

New London

State/Province

Connecticut

ZIP/Postal Code

06320

Country

United States

Facility Name

Novartis Investigative Site

City

Stratford

State/Province

Connecticut

ZIP/Postal Code

06615

Country

United States

Facility Name

Novartis Investigative Site

City

Dover

State/Province

Delaware

ZIP/Postal Code

19901

Country

United States

Facility Name

Novartis Investigative Site

City

Newark

State/Province

Delaware

ZIP/Postal Code

19713

Country

United States

Facility Name

Novartis Investigative Site

City

Atlantis

State/Province

Florida

ZIP/Postal Code

33462-6608

Country

United States

Facility Name

Novartis Investigative Site

City

Bradenton

State/Province

Florida

ZIP/Postal Code

32405

Country

United States

Facility Name

Novartis Investigative Site

City

Doral

State/Province

Florida

ZIP/Postal Code

33166

Country

United States

Facility Name

Novartis Investigative Site

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33308

Country

United States

Facility Name

Novartis Investigative Site

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33021

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

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

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United States

Facility Name

Novartis Investigative Site

City

Lighthouse Point

State/Province

Florida

ZIP/Postal Code

33064

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United States

Facility Name

Novartis Investigative Site

City

Maitland

State/Province

Florida

ZIP/Postal Code

32751

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United States

Facility Name

Novartis Investigative Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33015

Country

United States

Facility Name

Novartis Investigative Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33133

Country

United States

Facility Name

Novartis Investigative Site

City

Pompano Beach

State/Province

Florida

ZIP/Postal Code

33060

Country

United States

Facility Name

Novartis Investigative Site

City

Ponte Vedra Beach

State/Province

Florida

ZIP/Postal Code

32082-4627

Country

United States

Facility Name

Novartis Investigative Site

City

Port Orange

State/Province

Florida

ZIP/Postal Code

32127

Country

United States

Facility Name

Novartis Investigative Site

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34243

Country

United States

Facility Name

Novartis Investigative Site

City

St. Petersburg

State/Province

Florida

ZIP/Postal Code

33713

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

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Novartis Investigative Site

City

Vero Beach

State/Province

Florida

ZIP/Postal Code

32960

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United States

Facility Name

Novartis Investigative Site

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33407

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United States

Facility Name

Novartis Investigative Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30302

Country

United States

Facility Name

Novartis Investigative Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30309

Country

United States

Facility Name

Novartis Investigative Site

City

Columbus

State/Province

Georgia

ZIP/Postal Code

31901

Country

United States

Facility Name

Novartis Investigative Site

City

Decatur

State/Province

Georgia

ZIP/Postal Code

30083

Country

United States

Facility Name

Novartis Investigative Site

City

Idaho Falls

State/Province

Idaho

ZIP/Postal Code

83402

Country

United States

Facility Name

Novartis Investigative Site

City

Elk Grove Village

State/Province

Illinois

ZIP/Postal Code

60007

Country

United States

Facility Name

Novartis Investigative Site

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60201

Country

United States

Facility Name

Novartis Investigative Site

City

Flossmoor

State/Province

Illinois

ZIP/Postal Code

60422

Country

United States

Facility Name

Novartis Investigative Site

City

Northbrook

State/Province

Illinois

ZIP/Postal Code

60062

Country

United States

Facility Name

Novartis Investigative Site

City

Anderson

State/Province

Indiana

ZIP/Postal Code

46011

Country

United States

Facility Name

Novartis Investigative Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202-5111

Country

United States

Facility Name

Novartis Investigative Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46256

Country

United States

Facility Name

Novartis Investigative Site

City

Merrillville

State/Province

Indiana

ZIP/Postal Code

46410

Country

United States

Facility Name

Novartis Investigative Site

City

Valparaiso

State/Province

Indiana

ZIP/Postal Code

46383

Country

United States

Facility Name

Novartis Investigative Site

City

Des Moines

State/Province

Iowa

ZIP/Postal Code

50314-2611

Country

United States

Facility Name

Novartis Investigative Site

City

Lenexa

State/Province

Kansas

ZIP/Postal Code

66214

Country

United States

Facility Name

Novartis Investigative Site

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70809

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United States

Facility Name

Novartis Investigative Site

City

Destrehan

State/Province

Louisiana

ZIP/Postal Code

70047

Country

United States

Facility Name

Novartis Investigative Site

City

Hammond

State/Province

Louisiana

ZIP/Postal Code

70403

Country

United States

Facility Name

Novartis Investigative Site

City

Metairie

State/Province

Louisiana

ZIP/Postal Code

70001

Country

United States

Facility Name

Novartis Investigative Site

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71101

Country

United States

Facility Name

Novartis Investigative Site

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71130

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

Bethesda

State/Province

Maryland

ZIP/Postal Code

20814

Country

United States

Facility Name

Novartis Investigative Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02135

Country

United States

Facility Name

Novartis Investigative Site

City

Springfield

State/Province

Massachusetts

ZIP/Postal Code

01104

Country

United States

Facility Name

Novartis Investigative Site

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01608

Country

United States

Facility Name

Novartis Investigative Site

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01665

Country

United States

Facility Name

Novartis Investigative Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Novartis Investigative Site

City

Grand Rapids

State/Province

Michigan

ZIP/Postal Code

49503

Country

United States

Facility Name

Novartis Investigative Site

City

Kalamazoo

State/Province

Michigan

ZIP/Postal Code

49007

Country

United States

Facility Name

Novartis Investigative Site

City

Southfield

State/Province

Michigan

ZIP/Postal Code

48034

Country

United States

Facility Name

Novartis Investigative Site

City

Bolivar

State/Province

Missouri

ZIP/Postal Code

65613

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

Kansas City

State/Province

Missouri

ZIP/Postal Code

64132

Country

United States

Facility Name

Novartis Investigative Site

City

Nixa

State/Province

Missouri

ZIP/Postal Code

65714-7807

Country

United States

Facility Name

Novartis Investigative Site

City

North Kansas City

State/Province

Missouri

ZIP/Postal Code

64116

Country

United States

Facility Name

Novartis Investigative Site

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63104

Country

United States

Facility Name

Novartis Investigative Site

City

Billings

State/Province

Montana

ZIP/Postal Code

59102

Country

United States

Facility Name

Novartis Investigative Site

City

Freehold

State/Province

New Jersey

ZIP/Postal Code

07728

Country

United States

Facility Name

Novartis Investigative Site

City

Somerset

State/Province

New Jersey

ZIP/Postal Code

08873

Country

United States

Facility Name

Novartis Investigative Site

City

Teaneck

State/Province

New Jersey

ZIP/Postal Code

07666

Country

United States

Facility Name

Novartis Investigative Site

City

Toms River

State/Province

New Jersey

ZIP/Postal Code

08755

Country

United States

Facility Name

Novartis Investigative Site

City

Amherst

State/Province

New York

ZIP/Postal Code

14226

Country

United States

Facility Name

Novartis Investigative Site

City

Latham

State/Province

New York

ZIP/Postal Code

12110

Country

United States

Facility Name

Novartis Investigative Site

City

New York

State/Province

New York

ZIP/Postal Code

10023

Country

United States

Facility Name

Novartis Investigative Site

City

Patchogue

State/Province

New York

ZIP/Postal Code

11772

Country

United States

Facility Name

Novartis Investigative Site

City

Plainview

State/Province

New York

ZIP/Postal Code

11803

Country

United States

Facility Name

Novartis Investigative Site

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

28806

Country

United States

Facility Name

Novartis Investigative Site

City

Burlington

State/Province

North Carolina

ZIP/Postal Code

27215

Country

United States

Facility Name

Novartis Investigative Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28204

Country

United States

Facility Name

Novartis Investigative Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28207

Country

United States

Facility Name

Novartis Investigative Site

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27401

Country

United States

Facility Name

Novartis Investigative Site

City

Greenville

State/Province

North Carolina

ZIP/Postal Code

27834

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

Salisbury

State/Province

North Carolina

ZIP/Postal Code

28144

Country

United States

Facility Name

Novartis Investigative Site

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

Novartis Investigative Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Novartis Investigative Site

City

Akron

State/Province

Ohio

ZIP/Postal Code

44320

Country

United States

Facility Name

Novartis Investigative Site

City

Bellevue

State/Province

Ohio

ZIP/Postal Code

44811

Country

United States

Facility Name

Novartis Investigative Site

City

Canton

State/Province

Ohio

ZIP/Postal Code

44718

Country

United States

Facility Name

Novartis Investigative Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

Novartis Investigative Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43221

Country

United States

Facility Name

Novartis Investigative Site

City

Uniontown

State/Province

Ohio

ZIP/Postal Code

44685

Country

United States

Facility Name

Novartis Investigative Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

Novartis Investigative Site

City

Corvallis

State/Province

Oregon

ZIP/Postal Code

97330

Country

United States

Facility Name

Novartis Investigative Site

City

Eugene

State/Province

Oregon

ZIP/Postal Code

97401

Country

United States

Facility Name

Novartis Investigative Site

City

Medford

State/Province

Oregon

ZIP/Postal Code

97504

Country

United States

Facility Name

Novartis Investigative Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97223

Country

United States

Facility Name

Novartis Investigative Site

City

Monroeville

State/Province

Pennsylvania

ZIP/Postal Code

15146

Country

United States

Facility Name

Novartis Investigative Site

City

Rumford

State/Province

Rhode Island

ZIP/Postal Code

02916

Country

United States

Facility Name

Novartis Investigative Site

City

Beufort

State/Province

South Carolina

ZIP/Postal Code

29902

Country

United States

Facility Name

Novartis Investigative Site

City

Columbia

State/Province

Tennessee

ZIP/Postal Code

38401

Country

United States

Facility Name

Novartis Investigative Site

City

Cordova

State/Province

Tennessee

ZIP/Postal Code

38018

Country

United States

Facility Name

Novartis Investigative Site

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37934

Country

United States

Facility Name

Novartis Investigative Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37205

Country

United States

Facility Name

Novartis Investigative Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78756

Country

United States

Facility Name

Novartis Investigative Site

City

Colleyville

State/Province

Texas

ZIP/Postal Code

76034

Country

United States

Facility Name

Novartis Investigative Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75204

Country

United States

Facility Name

Novartis Investigative Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77025

Country

United States

Facility Name

Novartis Investigative Site

City

Lubbock

State/Province

Texas

ZIP/Postal Code

79410

Country

United States

Facility Name

Novartis Investigative Site

City

Plano

State/Province

Texas

ZIP/Postal Code

75075

Country

United States

Facility Name

Novartis Investigative Site

City

Round Rock

State/Province

Texas

ZIP/Postal Code

78681

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

San Antonio

State/Province

Texas

ZIP/Postal Code

78258

Country

United States

Facility Name

Novartis Investigative Site

City

Sherman

State/Province

Texas

ZIP/Postal Code

75092

Country

United States

Facility Name

Novartis Investigative Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84103

Country

United States

Facility Name

Novartis Investigative Site

City

Newport News

State/Province

Virginia

ZIP/Postal Code

23606

Country

United States

Facility Name

Novartis Investigative Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23226

Country

United States

Facility Name

Novartis Investigative Site

City

Roanoke

State/Province

Virginia

ZIP/Postal Code

24014

Country

United States

Facility Name

Novartis Investigative Site

City

Vienna

State/Province

Virginia

ZIP/Postal Code

22182

Country

United States

Facility Name

Novartis Investigative Site

City

Kirkland

State/Province

Washington

ZIP/Postal Code

98034

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

Seattle

State/Province

Washington

ZIP/Postal Code

98144

Country

United States

Facility Name

Novartis Investigative Site

City

Morgantown

State/Province

West Virginia

ZIP/Postal Code

26506-9260

Country

United States

Facility Name

Novartis Investigative Site

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 2T9

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

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

H3A 2B4

Country

Canada

Facility Name

Novartis Investigative Site

City

Guaynabo

ZIP/Postal Code

00969

Country

Puerto Rico

12. IPD Sharing Statement

Citations:

PubMed Identifier

26265274

Citation

Hughes B, Cascione M, Freedman MS, Agius M, Kantor D, Gudesblatt M, Goldstick LP, Agashivala N, Schofield L, McCague K, Hashmonay R, Barbato L; EPOC study investigators. First-dose effects of fingolimod after switching from injectable therapies in the randomized, open-label, multicenter, Evaluate Patient OutComes (EPOC) study in relapsing multiple sclerosis. Mult Scler Relat Disord. 2014 Sep;3(5):620-8. doi: 10.1016/j.msard.2014.06.006. Epub 2014 Jul 3.

Results Reference

derived

PubMed Identifier

26265273

Citation

Fox E, Edwards K, Burch G, Wynn DR, LaGanke C, Crayton H, Hunter SF, Huffman C, Kim E, Pestreich L, McCague K, Barbato L; EPOC study investigators. Outcomes of switching directly to oral fingolimod from injectable therapies: Results of the randomized, open-label, multicenter, Evaluate Patient OutComes (EPOC) study in relapsing multiple sclerosis. Mult Scler Relat Disord. 2014 Sep;3(5):607-19. doi: 10.1016/j.msard.2014.06.005. Epub 2014 Jul 4.

Results Reference

derived

PubMed Identifier

25424122

Citation

Calkwood J, Cree B, Crayton H, Kantor D, Steingo B, Barbato L, Hashmonay R, Agashivala N, McCague K, Tenenbaum N, Edwards K. Impact of a switch to fingolimod versus staying on glatiramer acetate or beta interferons on patient- and physician-reported outcomes in relapsing multiple sclerosis: post hoc analyses of the EPOC trial. BMC Neurol. 2014 Nov 26;14:220. doi: 10.1186/s12883-014-0220-1.

Results Reference

derived

PubMed Identifier

23647445

Citation

Cascione M, Wynn D, Barbato LM, Pestreich L, Schofield L, McCague K. Randomized, open-label study to evaluate patient-reported outcomes with fingolimod after changing from prior disease-modifying therapy for relapsing multiple sclerosis: EPOC study rationale and design. J Med Econ. 2013 Jul;16(7):859-65. doi: 10.3111/13696998.2013.802239. Epub 2013 May 20.

Results Reference

derived

Links:

URL

http://www.NovartisClinicalTrials.com

Description

Click here for more information about this study:

Learn more about this trial

A 6-month, Randomized, Open-label, Patient OutComes, Safety and Tolerability Study of Fingolimod (FTY720) 0.5 mg/Day vs. Comparator in Patients With Relapsing Forms of Multiple Sclerosis

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A 6-month, Randomized, Open-label, Patient OutComes, Safety and Tolerability Study of Fingolimod (FTY720) 0.5 mg/Day vs. Comparator in Patients With Relapsing Forms of Multiple Sclerosis (EPOC)

Relapsing Forms of Multiple Sclerosis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

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