Open-Label Extension Study to Evaluate the Safety, Tolerability and Ac
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
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Dalfampridine
Voltage-gated potassium channel blocker
Results by group
Summary of Treatment Emergent Adverse Events (TEAE).
up to 40 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Fampridine-SR | 205 participants | 214 | |
| Fampridine-SR | 39 participants | 214 | |
| Fampridine-SR | 46 participants | 214 | |
| Fampridine-SR | 7 participants | 214 | |
| Fampridine-SR | 1 participants | 214 | |
| Fampridine-SR | 29 participants | 214 | |
| Fampridine-SR | 120 participants | 214 | |
| Fampridine-SR | 56 participants | 214 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Fampridine-SR | 214 | 39 (18.2%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Summary of Treatment Emergent Adverse Events (TEAE).
up to 40 months
Nerve conduction testsSafety
Other measures (4)
Timed 25-Foot Walk (T25FW)
Week 2, 14, 26, continuing every 26 weeks until the Final Visit
Disability progressionWalking and mobilitySubject Global Impression (SGI)
Visit 1 and every clinic visit thereafter (other than the follow-up visit)
Clinician's Global Impression (CGI)
Visit 1 and every clinic visit thereafter
Expanded Disability Status Scale (EDSS)
The Screening Visit, Visit 6, Final Visit or Early Termination Visit (if applicable)
Disability progression
Who could take part
MS (type not specified) · 18 to 70
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The purpose of the study is to evaluate the safety, tolerability and activity of Fampridine-SR when administered for up to 36 additional months in patients who previously participated in the MS-F204 study or until it becomes commercially available, whichever comes first.
Papers
Loading reviews and guidelines…
Linked trials
Extended by
Open Label Extension Study to Evaluate the Safety and Tolerability ofPhase 3 · Completed
Links found where a registry record names another trial's registry number.
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History
Started
Aug 2007
Main results due
Jan 2011
Finished
Apr 2011
Results posted
Feb 2012