Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis Who Participated in the MS-F204 Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00649792
• Date of registration: 28/03/2008
• Prospective Registration: No
• Primary sponsor: Acorda Therapeutics
• Public title: Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis Who Participated in the MS-F204 Trial
• Scientific title: Phase 3 Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis Who Participated in the MS-F204 Trial
• Date of first enrolment: August 2007
• Target sample size: 214
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00649792
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Canada, United States

Contacts

• Name: Bonnie Faust
• Affiliation: Acorda Therapeutics

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patient must have been previously enrolled in the Acorda Therapeutics MS-F204 study
and received either Fampridine-SR or placebo

- Patient with clinically defined multiple sclerosis (the diagnostic criteria based on:
McDonald WI, et al. Recommended Diagnostic Criteria for Multiple Sclerosis: Guidelines
from the International Panel on the Diagnosis of Multiple Sclerosis. Annals of
Neurology. 2001; 50: 121-127)

- Patient must be at least 18 years of age. Any patient who is now over the age of 70
must be in good overall health in the judgment of the investigator

- Patient must be of adequate cognitive function, as judged by the Investigator

- Patients who are women of childbearing potential must have a negative urine pregnancy
test at the screening visit

Exclusion Criteria:

- Female patients who are either pregnant or breastfeeding.

- Women of childbearing potential who are not using a specified birth control method

- Patients discontinued prematurely from the MS-F204 study

- Patients with a history of seizures or with evidence of past, or possible epileptiform
activity on an EEG

- Patient with either a clinically significant abnormal ECG or laboratory values at the
MS-F204 EXT screening visit

- Patient with severe renal impairment

- Patient with angina, uncontrolled hypertension, clinically significant cardiac
arrhythmias, or any other clinically significant cardiovascular abnormality, as judged
by the Investigator

- Patient with a known allergy to pyridine-containing substances or any of the inactive
ingredients of the Fampridine-SR tablet

- Patient who has received an investigational drug (other than Fampridine-SR or placebo
under MS-F204 study) within 30 days of the MS-F204EXT screening visit or a patient who
is scheduled to enroll in an investigational drug trial at any time during this study

- Patient who has a history of drug or alcohol abuse within the past year



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Fampridine-SR

Primary Outcome(s)

Summary of Treatment Emergent Adverse Events (TEAE). [Time Frame: up to 40 months]

Secondary Outcome(s)

Expanded Disability Status Scale (EDSS) [Time Frame: The Screening Visit, Visit 6, Final Visit or Early Termination Visit (if applicable)]

Timed 25-Foot Walk (T25FW) [Time Frame: Week 2, 14, 26, continuing every 26 weeks until the Final Visit]

Clinician's Global Impression (CGI) [Time Frame: Visit 1 and every clinic visit thereafter]

Subject Global Impression (SGI) [Time Frame: Visit 1 and every clinic visit thereafter (other than the follow-up visit)]

Secondary ID(s)

MS-F204 EXT

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 27/02/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00649792