Study of Fampridine-SR Tablets in Multiple Sclerosis Patients
Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate Safety and Efficacy of Oral Fampridine-SR (10 mg b.i.d. [Bis in Die, Twice Daily]) in Patients With Multiple Sclerosis
1 other identifier
interventional
240
2 countries
40
Brief Summary
The purpose of the study is to show that individuals treated with Fampridine-SR tablets are significantly more likely to have consistent improvements in their walking than those treated with placebo tablets.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 multiple-sclerosis
Started May 2007
Shorter than P25 for phase_3 multiple-sclerosis
40 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
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 6, 2007
CompletedFirst Posted
Study publicly available on registry
June 7, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedResults Posted
Study results publicly available
April 14, 2011
CompletedFebruary 4, 2016
January 1, 2016
9 months
June 6, 2007
November 22, 2010
January 4, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Responders Based Upon the Timed 25-Foot Walk [T25FW]
A responder is a patient who showed faster walking speed for at least 3 visits out of a possible 4 during the double-blind period than the maximum value achieved in the 5 non-double-blind no-treatment visits (4 before the double-blind period and one after)
Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77
Secondary Outcomes (1)
Change in Lower Extremity Manual Muscle Test [LEMMT]
Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77
Study Arms (2)
Placebo
PLACEBO COMPARATORPlacebo control
Fampridine-SR
ACTIVE COMPARATOR10 mg b.i.d.
Interventions
Eligibility Criteria
You may qualify if:
- Patient with clinically defined multiple sclerosis
- All patients must be able to complete two trials of a timed 25 foot walk
You may not qualify if:
- Female patients who are either pregnant or breastfeeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Barrow Neurology Clinic, St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
HOPE Research Institute
Phoenix, Arizona, 85050, United States
Neurological Associates
Fayetteville, Arkansas, 72703, United States
Alta Bates Summit Medical Center - Research and Education Institute
Berkeley, California, 94705, United States
USC, Keck School of Medicine Health Care Consultation Center
Los Angeles, California, 90033, United States
UC Davis
Sacramento, California, 95817, United States
Yale University MS Center
New Haven, Connecticut, 06510, United States
Shepherd Center
Atlanta, Georgia, 30309, United States
Consultants in Neurology, Ltd.
Northbrook, Illinois, 60062, United States
Indiana University MS Center
Indianapolis, Indiana, 46202, United States
Associates in Neurology, PSC
Lexington, Kentucky, 40503, United States
Maryland Center for MS
Baltimore, Maryland, 21201, United States
Lahey Clinic
Lexington, Massachusetts, 02421, United States
The Schapiro Center for MS
Golden Valley, Minnesota, 55422, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Advanced Neurology Specialists
Great Falls, Montana, 59405, United States
UMDNJ
Newark, New Jersey, 07103, United States
Gimbel MS Center at Holy Name Hospital
Teaneck, New Jersey, 07666, United States
Jacobs Neurological Institute Buffalo General Hospital
Buffalo, New York, 14203, United States
Corinne Goldsmith Dickinson Center for MS
New York, New York, 10029, United States
Columbia University Multiple Sclerosis Clinical Care Center
New York, New York, 10032, United States
University of Rochester
Rochester, New York, 14642, United States
SUNY Stony Brook
Stony Brook, New York, 11794, United States
CMC - Neuroscience & Spine Institute, Division of Neurology
Charlotte, North Carolina, 28207, United States
Raleigh Neurology Associates
Raleigh, North Carolina, 27607, United States
Wake Forest University, Dept of Neurology, M.S. Research
Winston-Salem, North Carolina, 27157, United States
The Center for Neurological Services
Bismarck, North Dakota, 58501, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University MS Center
Columbus, Ohio, 43221, United States
Oregon Health & Science University, MS Center of Oregon, UHS-42
Portland, Oregon, 97239, United States
Thomas Jefferson University Physicians
Philadelphia, Pennsylvania, 19107, United States
Neurological Research Center, Inc.
Bennington, Vermont, 05201, United States
Fletcher Allen Health Care
Burlington, Vermont, 05401, United States
MS Center at Evergreen
Kirkland, Washington, 98034, United States
CAMC Health Education & Research Institute
Charleston, West Virginia, 25304, United States
Center for Neurological Disorders of Aurora, St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Foothills Medical Center
Calgary, Alberta, T2N 2T9, Canada
University of British Columbia, Vancouver Coastal Health Research Institute
Vancouver, British Columbia, V6T 2B5, Canada
River Valley Health c/o Stan Cassidy Centre for Rehabilitation
Fredericton, New Brunswick, E3B 0C7, Canada
QEII Health Sciences Centre, Nova Scotia Rehabilitation Centre Site
Halifax, Nova Scotia, B3H 4K4, Canada
Related Publications (1)
Goodman AD, Brown TR, Edwards KR, Krupp LB, Schapiro RT, Cohen R, Marinucci LN, Blight AR; MSF204 Investigators. A phase 3 trial of extended release oral dalfampridine in multiple sclerosis. Ann Neurol. 2010 Oct;68(4):494-502. doi: 10.1002/ana.22240.
PMID: 20976768RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Andrew Blight, Chief Scientific Officer
- Organization
- Acorda Therapeutics, Inc.
Study Officials
- STUDY DIRECTOR
Andrew Blight, PhD
Acorda Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2007
First Posted
June 7, 2007
Study Start
May 1, 2007
Primary Completion
February 1, 2008
Study Completion
May 1, 2008
Last Updated
February 4, 2016
Results First Posted
April 14, 2011
Record last verified: 2016-01