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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Acorda Therapeutics
ClinicalTrials.gov Identifier:
NCT00649792
First received: March 28, 2008
Last updated: February 24, 2012
Last verified: January 2012
  Purpose

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 Intervention Phase
Multiple Sclerosis
Drug: Fampridine-SR
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Acorda Therapeutics:

Primary Outcome Measures:
  • Summary of Treatment Emergent Adverse Events (TEAE). [ Time Frame: up to 40 months ] [ Designated as safety issue: No ]
    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:
  • Timed 25-Foot Walk (T25FW) [ Time Frame: Week 2, 14, 26, continuing every 26 weeks until the Final Visit ] [ Designated as safety issue: No ]
  • Subject Global Impression (SGI) [ Time Frame: Visit 1 and every clinic visit thereafter (other than the follow-up visit) ] [ Designated as safety issue: No ]
    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.

  • Clinician's Global Impression (CGI) [ Time Frame: Visit 1 and every clinic visit thereafter ] [ Designated as safety issue: No ]
    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.

  • Expanded Disability Status Scale (EDSS) [ Time Frame: The Screening Visit, Visit 6, Final Visit or Early Termination Visit (if applicable) ] [ Designated as safety issue: No ]
    The EDSS was used to grade patient disability on a scale from 0.0 (normal neurological exam) to 10.0 (death)


Enrollment: 214
Study Start Date: August 2007
Study Completion Date: April 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Fampridine-SR
    Tablets, 10 mg, BID (twice daily)
    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 over a long period of time.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00649792

  Show 42 Study Locations
Sponsors and Collaborators
Acorda Therapeutics
Investigators
Study Director: Bonnie Faust Acorda Therapeutics
  More Information

No publications provided

Responsible Party: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT00649792     History of Changes
Other Study ID Numbers: MS-F204 EXT
Study First Received: March 28, 2008
Results First Received: January 25, 2012
Last Updated: February 24, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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 July 26, 2014