Study of Oral Fampridine-SR in Multiple Sclerosis
Double-Blind, Placebo-Controlled, 21-Week, Parallel Group Study to Evaluate Safety and Efficacy of Oral Fampridine-SR in Subjects With Multiple Sclerosis
1 other identifier
interventional
300
2 countries
34
Brief Summary
To assess the safety and efficacy of 10 milligram (mg) twice a day (b.i.d.) Fampridine-SR in patients diagnosed with multiple sclerosis (MS), in a double-blind, placebo-controlled, parallel group study.
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 2005
Shorter than P25 for phase_3 multiple-sclerosis
34 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, 2005
CompletedFirst Submitted
Initial submission to the registry
August 4, 2005
CompletedFirst Posted
Study publicly available on registry
August 8, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedResults Posted
Study results publicly available
May 6, 2011
CompletedSeptember 11, 2018
August 1, 2018
1.1 years
August 4, 2005
April 12, 2011
August 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Timed Walk Responders (Patients Who Showed Consistent Improvement on the Timed-25 Foot Walk)
Patients who showed a faster walking speed for at least three of the four on-drug visits during the double-blind treatment period as compared to the maximum speed for any of the five off-drug visits.
Days 14, 42, 70 and 98 of treatment, corresponding to the four on-drug visits during double-blind treatment period.
Secondary Outcomes (1)
Lower Extremity Manual Muscle Test; Ashworth Score for Spasticity
Days 14, 42, 70, 98
Study Arms (2)
Placebo- sugar pill
PLACEBO COMPARATORPlacebo control
Fampridine-SR
EXPERIMENTAL10 milligram (mg) tablet b.i.d.
Interventions
Tablets, 10 mg, twice daily, 14 weeks
Eligibility Criteria
You may qualify if:
- Have a confirmed diagnosis of multiple sclerosis
- Are able to walk with or without an assistive 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 (34)
University of Alabama
Birmingham, Alabama, 35233, United States
Barrow Neurology Clinic, St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
USC, Keck School of Medicine
Los Angeles, California, 90033, United States
UC Davis
Sacramento, California, 95817, United States
University of Colorado Health Sciences Center
Denver, Colorado, 80262, United States
Multiple Sclerosis Treatment Center
Derby, Connecticut, 06418, United States
Shepard Center
Atlanta, Georgia, 30309, United States
University of Chicago
Chicago, Illinois, 60637, United States
Indiana University MS Center
Indianapolis, Indiana, 46202, United States
Maryland Center for MS
Baltimore, Maryland, 21201, United States
Wayne State University, Department of Neurology
Detroit, Michigan, 48201, United States
The Schapiro Center for MS
Golden Valley, Minnesota, 55422, United States
Washington University SOM
St Louis, Missouri, 63110, United States
Gimbel MS Center at Holy Name Hospital
Teaneck, New Jersey, 07666, United States
University of Mexico, MIND Imaging Center
Albuquerque, New Mexico, 87131, United States
Maimonides Medical Center
Brooklyn, New York, 11220, United States
Corinne Goldsmith Dickinson Center for MS
New York, New York, 10029, United States
University of Rochester
Rochester, New York, 14642, United States
SUNY - Stony Brook
Stony Brook, New York, 11794, United States
Carolinas Healthcare System
Charlotte, North Carolina, 28207, United States
Cleveland Clinical Foundation
Cleveland, Ohio, 44095, 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
Allegheny General Hospital, Allegheny Neurological Associates
Pittsburgh, Pennsylvania, 15212, United States
University of Texas - Houston
Houston, Texas, 77030, United States
Neurological Research Center, Inc.
Bennington, Vermont, 05201, United States
Fletcher Allen Health Care
Burlington, Vermont, 05401, United States
MS Hub Medical Group
Seattle, Washington, 98101, United States
University of Washington, MS Research Center
Seattle, Washington, 98195, 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
QEII Health Sciences Centre, Nova Scotia Rehabilitation Centre Site
Halifax, Nova Scotia, B3H 4K4, Canada
Ottawa Hospital General Campus
Ottawa, Ontario, K1H 8L6, Canada
Related Publications (1)
Goodman AD, Brown TR, Krupp LB, Schapiro RT, Schwid SR, Cohen R, Marinucci LN, Blight AR; Fampridine MS-F203 Investigators. Sustained-release oral fampridine in multiple sclerosis: a randomised, double-blind, controlled trial. Lancet. 2009 Feb 28;373(9665):732-8. doi: 10.1016/S0140-6736(09)60442-6.
PMID: 19249634RESULT
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
August 4, 2005
First Posted
August 8, 2005
Study Start
May 1, 2005
Primary Completion
June 1, 2006
Study Completion
September 1, 2006
Last Updated
September 11, 2018
Results First Posted
May 6, 2011
Record last verified: 2018-08