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

Sponsor:	Acorda Therapeutics
Information provided by:	Acorda Therapeutics
ClinicalTrials.gov Identifier:	NCT00053417

Purpose

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.

Condition	Intervention	Phase
Multiple Sclerosis	Drug: Placebo Drug: 10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP) Drug: 15 mg fampridine-SR (4-aminopyridine, 4-AP) Drug: 20 mg fampridine-SR (4-aminopyridine, 4-AP)	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: 4-Aminopyridine

U.S. FDA Resources

Further study details as provided by Acorda Therapeutics:

Primary Outcome Measures:

Median Percent Change From Baseline in Average Walking Speed on Timed 25-Foot Walk Test [ Time Frame: Baseline (placebo run-in period); 12-week stable dose period ] [ Designated as safety issue: No ]
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).

Enrollment:	206
Study Start Date:	February 2003
Study Completion Date:	December 2003
Primary Completion Date:	December 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1 Placebo control, twice a day (b.i.d.)	Drug: Placebo Placebo for 15 weeks
Experimental: 2 10 milligram (mg) fampridine b.i.d.	Drug: 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)
Experimental: 3 15 mg fampridine b.i.d.	Drug: 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)
Experimental: 4 20 mg fampridine b.i.d.	Drug: 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)

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00053417

Show 25 Study Locations

Sponsors and Collaborators

Acorda Therapeutics

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Andrew Blight/Chief Scientific Officer, Acorda Therapeutics
ClinicalTrials.gov Identifier:	NCT00053417 History of Changes
Other Study ID Numbers:	MS-F202
Study First Received:	January 29, 2003
Results First Received:	May 16, 2011
Last Updated:	August 3, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Acorda Therapeutics:

Walking Ability
Muscle strength
Spasticity

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases

Pathologic Processes
4-Aminopyridine
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012