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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.

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
BIIB041 (Fampridine-SR)
Sponsored by
Biogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Foothills Medical Center
  • University of British Columbia
  • River Valley Health
  • QEII Health Sciences Centre
  • Ottawa Hospital General Campus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BIIB041 (Fampridine-SR)

Arm Description

Participants take 10 mg sustained-release tablets of fampridine twice daily for up to 27 months or until the product is commercially available.

Outcomes

Primary Outcome Measures

Adverse events (AEs) and serious adverse events (SAEs) as well as Changes in vital signs and clinical laboratory assessments

Secondary Outcome Measures

Full Information

First Posted
November 4, 2010
Last Updated
July 3, 2014
Sponsor
Biogen
Collaborators
Acorda Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT01235221
Brief Title
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.
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 Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen
Collaborators
Acorda Therapeutics

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BIIB041 (Fampridine-SR)
Arm Type
Experimental
Arm Description
Participants take 10 mg sustained-release tablets of fampridine twice daily for up to 27 months or until the product is commercially available.
Intervention Type
Drug
Intervention Name(s)
BIIB041 (Fampridine-SR)
Other Intervention Name(s)
Dalfampridine, Fampridine-ER, Ampyra, Fampyra, Fampridine-PR
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria : Previously enrolled in 1 of the 3 Acorda-sponsored studies (MS-F202EXT, MS-F203EXT, and MS-F204EXT) and continuing to receive fampridine-SR. Willing to comply with the required scheduling and assessments of the protocol. 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: Discontinued prematurely from the preceding study ((MS-F202EXT, MS-F203EXT, or MS-F204EXT). Any prior history of seizure, epilepsy, or other convulsive disorder. Any clinically significant abnormal laboratory values. New history of moderate or severe renal impairment. New history of angina, uncontrolled hypertension, clinically significant cardiac arrhythmias, or any other clinically significant cardiovascular abnormality, as judged by the Investigator. Any significant change in overall health that would preclude subject's participation in the study, in the opinion of the Investigator. Known allergy to pyridine-containing substances or any of the inactive ingredients of the fampridine-SR tablet 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. A history of drug or alcohol abuse within the past year. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
Foothills Medical Center
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
River Valley Health
City
Fredericton
State/Province
New Brunswick
Country
Canada
Facility Name
QEII Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
Ottawa Hospital General Campus
City
Ottawa
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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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