Safety and Efficacy Study of Oral Fampridine-SR in Patients With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Double-Blind, Placebo-Controlled, 20-Week, Parallel Group Study to Evaluate Safety, Tolerability and Activity of Oral Fampridine-SR in Subjects With Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00053417
• Other study ID #: MS-F202
• Status: Completed
• Phase: Phase 2
• First received: January 29, 2003
• Last updated: August 3, 2011
• Start date: February 2003
• Est. completion date: December 2003

Study information

• Verified date: August 2011
• Source: Acorda Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: December 2003
• Est. primary completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

INCLUSION CRITERIA:

• Have a confirmed diagnosis of Multiple Sclerosis

• Are able to walk with or without an assisted device

EXCLUSION CRITERIA:

• 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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Placebo
Placebo for 15 weeks
• 10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP)
2 week up titration (10 mg) 12 weeks stable dose (10 mg) 1 week down titration (10 mg)
• 15 mg fampridine-SR (4-aminopyridine, 4-AP)
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)
• 20 mg fampridine-SR (4-aminopyridine, 4-AP)
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)

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	St. Michael's Hospital	Toronto	Ontario
United States	University of New Mexico	Albuquerque	New Mexico
United States	Shepherd Center	Atlanta	Georgia
United States	University of Maryland at Baltimore	Baltimore	Maryland
United States	Maimonides MS Care Center	Brooklyn	New York
United States	Carolinas Medical Center MS Center	Charlotte	North Carolina
United States	University of Chicago	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	University of Texas-Houston	Houston	Texas
United States	USC MS Comprehensive Care Center	Los Angeles	California
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin
United States	Fairview MS Center	Minneapolis	Minnesota
United States	Yale University MS Center	New Haven	Connecticut
United States	Mt. Sinai School of Medicine - MS Center	New York	New York
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Barrow Neurological Institute at St. Joseph Hospital and Medical Center	Phoenix	Arizona
United States	Oregon Health Sciences University; MS Center	Portland	Oregon
United States	University of Rochester Medical School	Rochester	New York
United States	Swedish Medical MS Center	Seattle	Washington
United States	University of Washington School of Medicine	Seattle	Washington
United States	Washington University School of Medicine	St. Louis	Missouri
United States	SUNY Stony Brook	Stony Brook	New York
United States	Gimbel MS Center	Teaneck	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Acorda Therapeutics

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

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