Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis
Phase 3 Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis
1 other identifier
interventional
177
2 countries
22
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 multiple-sclerosis
Started Nov 2003
Longer than P75 for phase_3 multiple-sclerosis
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2003
CompletedFirst Submitted
Initial submission to the registry
April 4, 2008
CompletedFirst Posted
Study publicly available on registry
April 9, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedResults Posted
Study results publicly available
February 29, 2012
CompletedMarch 2, 2012
January 1, 2012
7.2 years
April 4, 2008
January 31, 2012
March 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Summary of Treatment Emergent Adverse Events (TEAE).
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.
over 7 years (2004-2011)
Secondary Outcomes (4)
Timed 25 Foot Walk (T25FW)
Screening visit, visit 4, every 12 weeks thereafter, Last Regular Visit, Follow Up Visit and Early Termination Visit
Subject Global Impression (SGI)
visit 1 and every clinic visit
Clinician Global Impression of Change (CGIC)
visit 1 and every clinic visit
Expanded Disability Status Scale (EDSS)
Screening visit, visit 6 and every 24 months thereafter
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Barrow Neurology Clinic, St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
USC, Keck School of Medicine Health Care Consultation Center
Los Angeles, California, 90033, United States
Shepherd Center
Atlanta, Georgia, 30309, United States
University of Chicago
Chicago, Illinois, 60637, United States
Maryland Center for MS
Baltimore, Maryland, 21201, United States
The Schapiro Center for MS
Golden Valley, Minnesota, 55422, United States
Washington University School of Medicine, Div. of Rehab/Neurology
St Louis, Missouri, 63110, United States
Gimbel MS Center at Holy Name Hospital
Teaneck, New Jersey, 07666, United States
University of Mexico, MIND Imaging Center
Albuquerque, New Mexico, 87131, United States
Maimonides MS Care Center
Brooklyn, New York, 11219, United States
Corinne Goldsmith Dickinson Center for MS
New York, New York, 10029, United States
University of Rochester
Rochester, New York, 14642, United States
SUNY Stony Brook
Stony Brook, New York, 11794, United States
CMC - Neuroscience & Spine Institute, Division of Neurology
Charlotte, North Carolina, 28207, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University MS Center
Columbus, Ohio, 43221, United States
Oregon Health & Science University, MS Center of Oregon, UHS-42
Portland, Oregon, 97239, United States
Thomas Jefferson University Physicians
Philadelphia, Pennsylvania, 19107, United States
University of Texas-Houston
Houston, Texas, 77030, United States
MS Center at Evergreen
Kirkland, Washington, 98034, United States
Foothills Medical Center
Calgary, Alberta, T2N 2T9, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1WB, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Andrew Blight, PhD Chief Scientific Officer
- Organization
- Acorda Therapeutics, Inc.
Study Officials
- STUDY DIRECTOR
Bonnie Faust
Acorda Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2008
First Posted
April 9, 2008
Study Start
November 1, 2003
Primary Completion
January 1, 2011
Study Completion
April 1, 2011
Last Updated
March 2, 2012
Results First Posted
February 29, 2012
Record last verified: 2012-01