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Open Label Extension Study to Evaluate the Safety and Tolerability of Oral Fampridine-Sustained Release (SR) in Canadian Participants With Multiple Sclerosis Who Participated in Acorda Extension Trials.

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ClinicalTrials.gov Identifier: NCT01235221
Recruitment Status : Completed
First Posted : November 5, 2010
Last Update Posted : July 4, 2014
Sponsor:
Collaborator:
Acorda Therapeutics
Information provided by (Responsible Party):
Biogen

Study Description
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Brief Summary:
The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB041 (fampridine-sustained release (SR)) treatment in Canadian participants with multiple sclerosis (MS) who previously participated in the registrational and extension studies conducted by Acorda. Those studies include NCT00654927 (MS-F202EXT), NCT00648908 (MS-F203EXT) and NCT00649792 (MS-F204EXT).

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: BIIB041 (Fampridine-SR) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Extension Study to Evaluate the Safety and Tolerability of Oral Fampridine SR in Canadian Subjects With Multiple Sclerosis Who Participated in Acorda Extension Trials
Study Start Date : December 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: BIIB041 (Fampridine-SR)
Participants take 10 mg sustained-release tablets of fampridine twice daily for up to 27 months or until the product is commercially available.
 Drug: BIIB041 (Fampridine-SR)
10 mg twice a day (BID) sustained-release (SR) tablets by mouth for up to 27 months (in addition to treatment in previous studies) or until the product is commercially available, whichever comes first. Doses of study treatment must be spaced at least 12 hours apart.
Other Names:
  • Dalfampridine
  • Fampridine-ER
  • Ampyra
  • Fampyra
  • Fampridine-PR


Outcome Measures
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Primary Outcome Measures :
  1. Adverse events (AEs) and serious adverse events (SAEs) as well as Changes in vital signs and clinical laboratory assessments [ Time Frame: From Screening (Day 0) to Termination (Month 27) ]

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

Key Inclusion Criteria :

  1. Previously enrolled in 1 of the 3 Acorda-sponsored studies (MS-F202EXT, MS-F203EXT, and MS-F204EXT) and continuing to receive fampridine-SR.
  2. Willing to comply with the required scheduling and assessments of the protocol.
  3. Female subjects of childbearing potential, regardless of sexual activity, must have a negative urine pregnancy test, and must practice effective contraception during the study and be willing and able to continue contraception for 1 month after their last dose of study treatment.

Key Exclusion Criteria:

  1. Discontinued prematurely from the preceding study ((MS-F202EXT, MS-F203EXT, or MS-F204EXT).
  2. Any prior history of seizure, epilepsy, or other convulsive disorder.
  3. Any clinically significant abnormal laboratory values.
  4. New history of moderate or severe renal impairment.
  5. New history of angina, uncontrolled hypertension, clinically significant cardiac arrhythmias, or any other clinically significant cardiovascular abnormality, as judged by the Investigator.
  6. Any significant change in overall health that would preclude subject's participation in the study, in the opinion of the Investigator.
  7. Known allergy to pyridine-containing substances or any of the inactive ingredients of the fampridine-SR tablet
  8. Received an investigational drug, except fampridine-SR under the preceding study (MS-F202EXT, MS-F203EXT, or MS-F204EXT), within the last 30 days, or the subject is scheduled to enroll in an investigational drug at any time during the study.
  9. A history of drug or alcohol abuse within the past year.
  10. Treatment with other forms of fampridine or 4-AP (e.g., compounded formulation of 4-AP) or 3,4-diaminopyridine (3,4-DAP).

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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): NCT01235221


Locations
Canada, Alberta
Foothills Medical Center
Calgary, Alberta, Canada
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada
Canada, New Brunswick
River Valley Health
Fredericton, New Brunswick, Canada
Canada, Nova Scotia
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada
Canada, Ontario
Ottawa Hospital General Campus
Ottawa, Ontario, Canada
Sponsors and Collaborators
Biogen
Acorda Therapeutics
Investigators
Study Director: Medical Director Biogen
More Information
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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01235221     History of Changes
Other Study ID Numbers: 218MS301
First Posted: November 5, 2010    Key Record Dates
Last Update Posted: July 4, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Sclerosis
Multiple 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