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Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis Who Participated in the MS-F204 Trial

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ClinicalTrials.gov Identifier: NCT00649792
Recruitment Status : Completed
First Posted : April 1, 2008
Results First Posted : February 27, 2012
Last Update Posted : February 28, 2012
Sponsor:
Information provided by (Responsible Party):
Acorda Therapeutics

Study Description
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Brief Summary:
The purpose of the study is to evaluate the safety, tolerability and activity of Fampridine-SR when administered for up to 36 additional months in patients who previously participated in the MS-F204 study or until it becomes commercially available, whichever comes first.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Fampridine-SR Phase 3

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 over a long period of time.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 214 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 3 Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis Who Participated in the MS-F204 Trial
Study Start Date : August 2007
Actual Primary Completion Date : January 2011
Actual Study Completion Date : April 2011

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Arms and Interventions
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Intervention Details:
  • Drug: Fampridine-SR
    Tablets, 10 mg, BID (twice daily)
    Other Name: 4-aminopyridine

Outcome Measures
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Primary Outcome Measures :
  1. Summary of Treatment Emergent Adverse Events (TEAE). [ Time Frame: up to 40 months ]
    All adverse events reported were treatment emergent. Therefore, events that had a date of onset, or worsening, on or after the start of the open-label drug and up to 14 days after the last dose (for non-serious events) or up to 30 days after the last dose (for SAEs) were summarized. Any abnormal clinically significant changes in physical examination, medical history, clinical laboratory testing, 12-lead ECG, and standard EEG testing were captured as adverse events.


Secondary Outcome Measures :
  1. Timed 25-Foot Walk (T25FW) [ Time Frame: Week 2, 14, 26, continuing every 26 weeks until the Final Visit ]
  2. Subject Global Impression (SGI) [ Time Frame: Visit 1 and every clinic visit thereafter (other than the follow-up visit) ]
    For the SGI, the potential responses to the effects of the investigational drug during the preceding week were 1=terrible, 2=unhappy, 3=mostly dissatisfied, 4=neutral/ mixed, 5=mostly satisfied, 6=pleased, and 7=delighted.

  3. Clinician's Global Impression (CGI) [ Time Frame: Visit 1 and every clinic visit thereafter ]
    The potential responses were 1=very much improved, 2=much improved, 3=somewhat improved, 4=no change, 5=somewhat worse, 6=much worse, and 7=very much worse.

  4. Expanded Disability Status Scale (EDSS) [ Time Frame: The Screening Visit, Visit 6, Final Visit or Early Termination Visit (if applicable) ]
    The EDSS was used to grade patient disability on a scale from 0.0 (normal neurological exam) to 10.0 (death)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient must have been previously enrolled in the Acorda Therapeutics MS-F204 study and received either Fampridine-SR or placebo
  • Patient with clinically defined multiple sclerosis (the diagnostic criteria based on: McDonald WI, et al. Recommended Diagnostic Criteria for Multiple Sclerosis: Guidelines from the International Panel on the Diagnosis of Multiple Sclerosis. Annals of Neurology. 2001; 50: 121-127)
  • Patient must be at least 18 years of age. Any patient who is now over the age of 70 must be in good overall health in the judgment of the investigator
  • Patient must be of adequate cognitive function, as judged by the Investigator
  • Patients who are women of childbearing potential must have a negative urine pregnancy test at the screening visit

Exclusion Criteria:

  • Female patients who are either pregnant or breastfeeding.
  • Women of childbearing potential who are not using a specified birth control method
  • Patients discontinued prematurely from the MS-F204 study
  • Patients with a history of seizures or with evidence of past, or possible epileptiform activity on an EEG
  • Patient with either a clinically significant abnormal ECG or laboratory values at the MS-F204 EXT screening visit
  • Patient with severe renal impairment
  • Patient with angina, uncontrolled hypertension, clinically significant cardiac arrhythmias, or any other clinically significant cardiovascular abnormality, as judged by the Investigator
  • Patient with a known allergy to pyridine-containing substances or any of the inactive ingredients of the Fampridine-SR tablet
  • Patient who has received an investigational drug (other than Fampridine-SR or placebo under MS-F204 study) within 30 days of the MS-F204EXT screening visit or a patient who is scheduled to enroll in an investigational drug trial at any time during this study
  • Patient who has a history of drug or alcohol abuse within the past year
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00649792


Locations
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Sponsors and Collaborators
Acorda Therapeutics
Investigators
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Study Director: Bonnie Faust Acorda Therapeutics
More Information
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Additional Information:

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Responsible Party: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT00649792    
Other Study ID Numbers: MS-F204 EXT
First Posted: April 1, 2008    Key Record Dates
Results First Posted: February 27, 2012
Last Update Posted: February 28, 2012
Last Verified: January 2012
Keywords provided by Acorda Therapeutics:
multiple sclerosis
MS
walking
leg strength
demyelination
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
 Autoimmune Diseases
Immune System Diseases
4-Aminopyridine
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action