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Open-Label Extension Study

This study is ongoing, but not recruiting participants.

Sponsored by: Acorda Therapeutics
Information provided by: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT00654927
  Purpose

The purpose of this study is to evaluate the long-term safety, tolerability and activity of Fampridine-SR in subjects with multiple sclerosis who have previously participated in either an Acorda Therapeutics or an Elan Corporation sponsored protocol. Subjects are eligible regardless of whether they received active drug or placebo during their participation in the previous study.


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

MedlinePlus related topics:   Multiple Sclerosis   

ChemIDplus related topics:   4-Aminopyridine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:   Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Subjects With Multiple Sclerosis

Further study details as provided by Acorda Therapeutics:

Primary Outcome Measures:
  • Timed 25 Foot Walk [ Time Frame: Screening visit, visit 4, every 12 weeks thereafter, Last Regular Visit, Follow Up Visit and Early Termination Visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinician Global Impression of Change [ Time Frame: visit 1 and every clinic visit ] [ Designated as safety issue: No ]
  • Subject Global Impression [ Time Frame: visit 1 and every clinic visit ] [ Designated as safety issue: No ]
  • Expanded Disability Status Scale [ Time Frame: Screening visit, visit 6 and every 24 months thereafter ] [ Designated as safety issue: No ]

Enrollment:   177
Study Start Date:   November 2003

Intervention Details:
    Drug: Fampridine-SR
    Tablets, 10 mg, BID
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:

  • The subject must have been previously enrolled in an Acorda Therapeutics or an Elan Corporation sponsored study for multiple sclerosis and received either Fampridine or placebo.
  • The subject must have multiple sclerosis as determined by the Principal Investigator.
  • The subject, male or female, must be at least 18 years of age. Any subject who is now over the age of 70 must be in good overall health in the judgment of the Investigator.
  • The subject must be of adequate cognitive function, as judged by the Investigator.
  • Any subject who is female and of childbearing potential, regardless of sexual activity, must have a negative urine pregnancy test at the Screening Visit.

Exclusion Criteria:

  • The subject is a female who is either pregnant or breastfeeding, or of child-bearing potential, who, if engaged in active heterosexual relations and has not had a hysterectomy or bilateral oophorectomy, would not use one of the following birth control methods: tubal ligation, implantable contraception device, oral, injectable or transdermal contraceptive, barrier method or sexual activity restricted to vasectomized partner.
  • The subject withdrew from a previous Fampridine study because of a Serious Adverse Event that was possibly, probably or definitely related to Fampridine.
  • The subject has a history of seizures or has evidence of past, or possible, epileptiform activity on an EEG.
  • The subject has either a clinically significant abnormal ECG or laboratory value(s) at the Screening Visit, as judged by the Investigator
  • The subject has angina, uncontrolled hypertension, clinically significant cardiac arrhythmias, or any other clinically significant cardiovascular abnormality, as judged by the Investigator.
  • The subject has a known allergy to pyridine-containing substances or any of the inactive ingredients of the Fampridine tablet
  • The subject has received an investigational drug, except for Fampridine- SR (or matching placebo) under Protocol MS-F202, within 30 days prior to the Screening Visit; or the subject is scheduled to enroll in an investigational drug trial at any time during this study.
  • The subject has received compounded 4-aminopyridine (4-AP) within 14 days of the Screening Visit.
  • The subject has had an onset of an MS exacerbation within 30 days prior to the Screening Visit, or, if in the judgment of the Investigator, has not stabilized from a prior exacerbation episode.
  • The subject has started on a concomitant medication regimen for an underlying disease/symptom within the past 7 days; or has started an interferon or chemotherapeutic agent for multiple sclerosis within the past 4 weeks.
  • The subject has a history of drug or alcohol abuse within the past year.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00654927

Show 22 study locations  Show 22 Study Locations

Sponsors and Collaborators
Acorda Therapeutics
  More Information


(Click here for more information about Fampridine-SR clinical trials)  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Acorda Therapeutics, Inc. ( Andrew Blight/Chief Scientific Officer )
Study ID Numbers:   MS-F202 EXT
First Received:   April 4, 2008
Last Updated:   April 4, 2008
ClinicalTrials.gov Identifier:   NCT00654927
Health Authority:   United States: Food and Drug Administration;   Canada: Health Canada

Keywords provided by Acorda Therapeutics:
multiple sclerosis  
MS  
walking  
leg strength  
demyelination  

Study placed in the following topic categories:
Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Demyelinating Autoimmune Diseases, CNS
4-Aminopyridine
Demyelinating diseases
Sclerosis
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:
Membrane Transport Modulators
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Therapeutic Uses
Nervous System Diseases
Potassium Channel Blockers
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008




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