Safety and Efficacy Study of Oral Fampridine-SR in Patients With Multiple Sclerosis
Double-Blind, Placebo-Controlled, 20-Week, Parallel Group Study to Evaluate Safety, Tolerability and Activity of Oral Fampridine-SR in Subjects With Multiple Sclerosis
1 other identifier
interventional
206
2 countries
25
Brief Summary
Multiple Sclerosis (MS) is a disorder of the body's immune system that affects the Central Nervous System (CNS). Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with MS, the fatty sheath that surrounds and insulates the nerve fibers (called "myelin") deteriorates, causing nerve impulses to be slowed or stopped. As a result patients with MS may experience periods of muscle weakness and other symptoms such as numbness, loss of vision, loss of coordination, paralysis, spasticity, mental and physical fatigue and a decrease in the ability to think and/or remember. These periods of illness may come (exacerbations) and go (remissions). Fampridine-SR (Sustained Release, SR) is an experimental drug that increases the ability of the nerve to conduct electrical impulses. This study will evaluate the effects of Fampridine-SR on the walking ability of subjects with MS, as well as to examine the effects on muscle strength and spasticity. The study will also examine the possible risks of taking Fampridine-SR.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 multiple-sclerosis
Started Feb 2003
Shorter than P25 for phase_2 multiple-sclerosis
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2003
CompletedFirst Posted
Study publicly available on registry
January 30, 2003
CompletedStudy Start
First participant enrolled
February 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2003
CompletedResults Posted
Study results publicly available
August 4, 2011
CompletedAugust 4, 2011
August 1, 2011
10 months
January 29, 2003
May 16, 2011
August 3, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Median Percent Change From Baseline in Average Walking Speed on Timed 25-Foot Walk Test
The primary efficacy variable was the percent change from baseline in average walking speed measured using the Timed 25-Foot Walk Test during the 12-week stable dose period (the average of Study Days 56, 84, and 112), relative to the mean at baseline (placebo run-in period, the average of Study Days 7 and 14).
Baseline (placebo run-in period); 12-week stable dose period
Study Arms (4)
1
PLACEBO COMPARATORPlacebo control, twice a day (b.i.d.)
2
EXPERIMENTAL10 milligram (mg) fampridine b.i.d.
3
EXPERIMENTAL15 mg fampridine b.i.d.
4
EXPERIMENTAL20 mg fampridine b.i.d.
Interventions
2 week up titration (10 mg) 12 weeks stable dose (10 mg) 1 week down titration (10 mg)
10 mg twice daily for 1 week 15 mg twice daily for 14 weeks 2 week up titration (10 mg x 1 week, 15 mg x 1 week) 12 weeks stable dose (15 mg) 1 week down titration (10 mg)
2 week up titration (10 mg x 1 week, 15 mg x 1 week) 12 weeks stable dose (20 mg) 1 week down titration (15 mg x 3 days, 10 mg x 4 days)
Eligibility Criteria
You may qualify if:
- Have a confirmed diagnosis of Multiple Sclerosis
- Are able to walk with or without an assisted device
You may not qualify if:
- Pregnancy, breastfeeding or females of childbearing potential not using adequate birth control
- Participating in other investigational drug trials
- A medical history or clinical findings that preclude entry into the study
- A medication history that precludes entry into the study
- Previously treated with 4-aminopyridine (4-AP)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Barrow Neurological Institute at St. Joseph Hospital and Medical Center
Phoenix, Arizona, 85013, United States
USC MS Comprehensive Care Center
Los Angeles, California, 90033, United States
Yale University MS Center
New Haven, Connecticut, 06510, United States
Shepherd Center
Atlanta, Georgia, 30309, United States
University of Chicago
Chicago, Illinois, 60637, United States
University of Maryland at Baltimore
Baltimore, Maryland, 21210, United States
Fairview MS Center
Minneapolis, Minnesota, 55454, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Gimbel MS Center
Teaneck, New Jersey, 07666, United States
University of New Mexico
Albuquerque, New Mexico, 87131, United States
Maimonides MS Care Center
Brooklyn, New York, 11219, United States
Mt. Sinai School of Medicine - MS Center
New York, New York, 10029, United States
University of Rochester Medical School
Rochester, New York, 14642, United States
SUNY Stony Brook
Stony Brook, New York, 11794, United States
Carolinas Medical Center MS Center
Charlotte, North Carolina, 28207, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University
Columbus, Ohio, 43210, United States
Oregon Health Sciences University; MS Center
Portland, Oregon, 97201, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
University of Texas-Houston
Houston, Texas, 77030, United States
Swedish Medical MS Center
Seattle, Washington, 98122, United States
University of Washington School of Medicine
Seattle, Washington, 98195, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
Foothills Medical Centre
Calgary, Alberta, T2N 2T9, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1WB, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Andrew Blight, PhD
- Organization
- Acorda Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 29, 2003
First Posted
January 30, 2003
Study Start
February 1, 2003
Primary Completion
December 1, 2003
Study Completion
December 1, 2003
Last Updated
August 4, 2011
Results First Posted
August 4, 2011
Record last verified: 2011-08