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.
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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 |
- 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:
|
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 |
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).
Contacts and 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 | |
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: | March 7, 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 May 16, 2013