Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR Tablets in Multiple Sclerosis Patients Who Participated in the MS-F203 Trial

February 24, 2012 updated by: Acorda Therapeutics

Phase 3 Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Subjects With Multiple Sclerosis Who Participated in the MS-F203 Trial

The purpose of this study is to evaluate the safety, tolerability and activity of Fampridine-SR when administered for up to 36 additional months, or until it becomes commercially available whichever comes first, in subjects who previously participated in Acorda Therapeutics Protocol MS-F203.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

269

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Foothills Medical Center
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 2B5
        • University of British Columbia, Vancouver Coastal Health Research Institute
    • New Brunswick
      • Fredericton, New Brunswick, Canada, E3B 0C7
        • River Valley Health c/o Stan Cassidy Centre for Rehabilitation
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 4K4
        • QEII Health Sciences Centre, Nova Scotia Rehabilitation Centre Site
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Hospital General Campus
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Barrow Neurology Clinic, St. Joseph's Hospital and Medical Center
    • California
      • Los Angeles, California, United States, 90033
        • USC, Keck School of Medicine Health Care Consultation Center
      • Sacramento, California, United States, 95817
        • UC Davis
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Shepherd Center
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University MS Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Maryland Center for MS
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University, Department of Neurology
    • Minnesota
      • Golden Valley, Minnesota, United States, 55422
        • The Schapiro Center for MS
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine, Div. of Rehab/Neurology
    • Montana
      • Great Falls, Montana, United States, 59405
        • Advanced Neurology Specialists
    • New Jersey
      • Teaneck, New Jersey, United States, 07666
        • Gimbel MS Center at Holy Name Hospital
    • New York
      • Brooklyn, New York, United States, 11219
        • Maimonides MS Care Center
      • New York, New York, United States, 10029
        • Corinne Goldsmith Dickinson Center for MS
      • Rochester, New York, United States, 14642
        • University of Rochester
      • Stony Brook, New York, United States, 11794
        • SUNY Stony Brook
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • CMC - Neuroscience & Spine Institute, Division of Neurology
      • Raleigh, North Carolina, United States, 27607
        • Raleigh Neurology Associates
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43221
        • Ohio State University MS Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University, MS Center of Oregon, UHS-42
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Physicians
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital, Allegheny Neurological Associates
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas-Houston
    • Vermont
      • Bennington, Vermont, United States, 05201
        • Neurological Research Center, Inc.
      • Burlington, Vermont, United States, 05401
        • Fletcher Allen Health Care
    • Washington
      • Kirkland, Washington, United States, 98034
        • MS Center at Evergreen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • subject must have been previously enrolled in Acorda Therapeutics MS-F203 study for multiple sclerosis and received either Fampridine-SR or placebo
  • subject is a man or woman with clinical definite multiple sclerosis as defined by McDonald (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)
  • subject 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
  • subject must be of adequate cognitive function, as judged by the Investigator, to understand and sign the IRB/REB-approved informed consent form prior to the performance of any study-specific procedures and is willing to comply with the required scheduling and assessments of the protocol
  • subjects who are women of childbearing potential, regardless of sexual activity, must have a negative urine pregnancy test at the Screening Visit.

Exclusion Criteria:

  • women who are either pregnant or breastfeeding, and women of childbearing potential (defined as not surgically sterile or at least two years post menopausal) who are engaged in active heterosexual relations and, are not using one of the following birth control methods: tubal ligation, implantable contraception device, oral, patch, injectable or transdermal contraceptive, barrier method or sexual activity restricted to vasectomized partner.
  • subject discontinued prematurely from the MS-F203 study
  • subject has a history of seizures or has evidence of past, or possible, epileptiform activity on an EEG
  • subject has either a clinically significant abnormal ECG or laboratory value(s) at the Screening visit, as judged by the Investigator that would preclude entry into the study. ECG and laboratory results from Visit 6 or repeat results from Visit 7 of the MS-F203 study may be used as the baseline for the current study
  • subject has angina, uncontrolled hypertension, clinically significant cardiac arrhythmias, or any other clinically significant cardiovascular abnormality, as judged by the Investigator
  • subject has a known allergy to pyridine-containing substances or any of the inactive ingredients of the Fampridine-SR tablet (hydroxypropyl methylcellulose, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, opadry white (tablet film coating))
  • subject has received an investigational drug, except for Fampridine-SR or matching placebo under protocol MS-F203, within 30 days of the Screening Visit. Subject is scheduled to enroll in an investigational drug trial at any time during this study.
  • subject has a history of drug or alcohol abuse within the past year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Summary of Treatment Emergent Adverse Events (TEAE).
Time Frame: up to 5 years
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.
up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed 25 Foot Walk (T25FW)
Time Frame: Week 2, 14, 26, continuing every 26 weeks until the Final Visit
Week 2, 14, 26, continuing every 26 weeks until the Final Visit
Subject Global Impression (SGI)
Time Frame: visit 1 and every clinic visit

Patients asked to complete a Subject Impression questionnaire rating his/her impression of the effects of study drug during the preceding week, specifically in regards to signs and symptoms associated with Multiple Sclerosis (MS).

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.

visit 1 and every clinic visit
Clinician Global Impression of Change (CGIC)
Time Frame: visit 1 and every clinic visit

Investigator's overall impression of the patients neurological status and general state of health related to his/her participation in the study; specifically signs and symptoms associated with MS.

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.

visit 1 and every clinic visit
Expanded Disability Status Scale (EDSS)
Time Frame: Screening visit, visit 6 and every 24 months thereafter

Each patient, based on their baseline neurological exam, are scored according to the EDSS

The EDSS was used to grade patient disability on a scale from 0.0 (normal neurological exam) to 10.0 (death) at the Screening Visit, Visit 6, and Final Visit or Early Termination Visit if applicable.

Screening visit, visit 6 and every 24 months thereafter

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Bonnie Faust, Acorda Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

March 28, 2008

First Submitted That Met QC Criteria

March 28, 2008

First Posted (Estimate)

April 1, 2008

Study Record Updates

Last Update Posted (Estimate)

February 27, 2012

Last Update Submitted That Met QC Criteria

February 24, 2012

Last Verified

January 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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