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.

This study has been completed.
Sponsor:
Collaborator:
Acorda Therapeutics
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01235221
First received: November 4, 2010
Last updated: September 12, 2013
Last verified: March 2013
  Purpose

This is an open label study to evaluate the safety and tolerability of long term treatment with fampridine-SR 10 mg BID for up to 27 additional months or until availability of commercial product (whichever sooner) following treatment in Acorda sponsored Studies (MS-F202EXT, MS-F203EXT, and MS-F204EXT) and also the current recommendations of commercially available dalfampridine-ER in the US.


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: 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

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Enrollment: 38
Study Start Date: December 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Study drug Drug: Fampridine-SR
10 mg BID for all subjects
Other Names:
  • Dalfampridine
  • Fampridine-ER
  • Fampridine-PR

Detailed Description:

Primary Objectives The primary objective of the study is to evaluate the long-term safety and tolerability of fampridine-SR treatment in Canadian subjects with MS who previously participated in the registrational and extension studies conducted by Acorda.

Endpoints The primary endpoints include the safety parameters: adverse events (AEs) and serious adverse events (SAEs), as well as changes in vital signs and clinical laboratory assessments.

Study Location: Canada

Number of planned subjects: Approximately 38 subjects

Study Population: This study will be conducted in Canadian subjects with MS who participated in one of Acorda-sponsored studies (MS-F202EXT, MS-F203EXT, and MS-F204EXT).

Treatments Groups: All subjects will receive fampridine-SR

Duration of Treatment and Follow-up: The duration of the study treatment with fampridine-SR will be up to 27 months or until fampridine-SR becomes commercially available, whichever comes first. The Follow-up period will be 1 month after subjects' last dose of study treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 Idec
Acorda Therapeutics
  More Information

No publications provided

Responsible Party: Medical Director, Biogen Idec
ClinicalTrials.gov Identifier: NCT01235221     History of Changes
Other Study ID Numbers: 218MS301
Study First Received: November 4, 2010
Last Updated: September 12, 2013
Health Authority: Canada: Health Canada

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 April 17, 2014