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 Subjects With Multiple Sclerosis Who Participated in the MS-F203 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 5 years
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Fampridine-SR 10mg (Twice a Day) | 264 Participants | 269 | |
| Fampridine-SR 10mg (Twice a Day) | 94 Participants | 269 | |
| Fampridine-SR 10mg (Twice a Day) | 77 Participants | 269 | |
| Fampridine-SR 10mg (Twice a Day) | 37 Participants | 269 | |
| Fampridine-SR 10mg (Twice a Day) | 4 Participants | 269 | |
| Fampridine-SR 10mg (Twice a Day) | 16 Participants | 269 | |
| Fampridine-SR 10mg (Twice a Day) | 137 Participants | 269 | |
| Fampridine-SR 10mg (Twice a Day) | 111 Participants | 269 |
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 | 269 | 94 (34.9%) |
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 5 years
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
Clinician Global Impression of Change (CGIC)
visit 1 and every clinic visit
Expanded Disability Status Scale (EDSS)
Screening visit, visit 6 and every 24 months thereafter
Disability progression
Who could take part
MS (type not specified) · 18 to 70
Show the full criteria
Inclusion criteria
* subject must have been previously enrolled in Acorda Therapeutics MS-F203 study for multiple sclerosis and received either Fampridine-SR or placebo * subject is a man or woman with clinical definite multiple sclerosis as defined by McDonald (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) * subject must be at least 18 years of age. Any subject who is now over the age of 70 must be in good overall health in the judgment of the Investigator * subject must be of adequate cognitive function, as judged by the Investigator, to understand and sign the IRB/REB-approved informed consent form prior to the performance of any study-specific procedures and is willing to comply with the required scheduling and assessments of the protocol * subjects who are women of childbearing potential, regardless of sexual activity, must have a negative urine pregnancy test at the Screening Visit.
Exclusion criteria
* women who are either pregnant or breastfeeding, and women of childbearing potential (defined as not surgically sterile or at least two years post menopausal) who are engaged in active heterosexual relations and, are not using one of the following birth control methods: tubal ligation, implantable contraception device, oral, patch, injectable or transdermal contraceptive, barrier method or sexual activity restricted to vasectomized partner. * subject discontinued prematurely from the MS-F203 study * subject has a history of seizures or has evidence of past, or possible, epileptiform activity on an EEG * subject has either a clinically significant abnormal ECG or laboratory value(s) at the Screening visit, as judged by the Investigator that would preclude entry into the study. ECG and laboratory results from Visit 6 or repeat results from Visit 7 of the MS-F203 study may be used as the baseline for the current study * subject has angina, uncontrolled hypertension, clinically significant cardiac arrhythmias, or any other clinically significant cardiovascular abnormality, as judged by the Investigator * subject has a known allergy to pyridine-containing substances or any of the inactive ingredients of the Fampridine-SR tablet (hydroxypropyl methylcellulose, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, opadry white (tablet film coating)) * subject has received an investigational drug, except for Fampridine-SR or matching placebo under protocol MS-F203, within 30 days of the Screening Visit. Subject is scheduled to enroll in an investigational drug trial at any time during this study. * subject 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 this study is to evaluate the safety, tolerability and activity of Fampridine-SR when administered for up to 36 additional months, or until it becomes commercially available whichever comes first, in subjects who previously participated in Acorda Therapeutics Protocol MS-F203.
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
Jun 2006
Main results due
Jan 2011
Finished
Apr 2011
Results posted
Feb 2012