Study of Fampridine-SR Tablets in Multiple Sclerosis Patients - Full Text View

Sponsor:	Acorda Therapeutics
Information provided by:	Acorda Therapeutics
ClinicalTrials.gov Identifier:	NCT00483652

Purpose

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.

Condition	Intervention	Phase
Multiple Sclerosis	Drug: Fampridine-SR Drug: Placebo	Phase III

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, 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

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:

Responders Based Upon the Timed 25-Foot Walk [T25FW] [ Time Frame: Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77 ] [ Designated as safety issue: No ]
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)

Secondary Outcome Measures:

Change in Lower Extremity Manual Muscle Test [LEMMT] [ Time Frame: Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77 ] [ Designated as safety issue: No ]
Evaluator rated strength in hip flexors, knee flexors, knee extensors, and ankle dorsiflexors on the following scale: best value = 5.0 (normal muscle strength), worst value = 0.0 (absence of any voluntary contraction). A positive shift in LEMMT score shows improvement in strength. Change in LEMMT scores for the secondary efficacy measure was found by averaging the LEMMT scores on days 14, 28, 42, and 56 (double-blind treatment period) and subtracting the baseline LEMMT score.

Enrollment:	240
Study Start Date:	May 2007
Study Completion Date:	May 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo Placebo control	Drug: Placebo placebo (sugar pill) Other Name: placebo
Active Comparator: Fampridine-SR 10 mg b.i.d.	Drug: Fampridine-SR Tablets, 10 mg, twice daily, 9 weeks Other Name: 4-aminopyridine

Detailed Description:

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 is an experimental drug that has been reported to possibly improve muscle strength and walking ability for some people with MS. This study will evaluate the effects and possible risks of taking Fampridine-SR in MS patients

Eligibility

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

Criteria

Inclusion Criteria:

Patient with clinically defined multiple sclerosis
All patients must be able to complete two trials of a timed 25 foot walk

Exclusion Criteria:

Female patients who are either pregnant or breastfeeding.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00483652

Show 40 Study Locations

Sponsors and Collaborators

Acorda Therapeutics

Investigators

Study Director:

Andrew Blight, PhD

Acorda Therapeutics

More Information

Publications:

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.

Responsible Party:	Andrew Blight/Chief Scientific Officer, Acorda Therapeutics
ClinicalTrials.gov Identifier:	NCT00483652 History of Changes
Other Study ID Numbers:	MS-F204
Study First Received:	June 6, 2007
Results First Received:	November 22, 2010
Last Updated:	April 14, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Acorda Therapeutics:

multiple sclerosis
MS
walking
leg strength
demyelination

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