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

CompletedPhase 3MS (type not specified)NCT00654927

What it found

Results posted, not judged

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

Results by group

Summary of Treatment Emergent Adverse Events (TEAE).

over 7 years (2004-2011)

GroupValueIntervalNumber analysed
Fampridine-SR b.i.d.176 participants99.4177
Fampridine-SR b.i.d.65 participants36.7177
Fampridine-SR b.i.d.102 participants41.8177
Fampridine-SR b.i.d.34 participants15.3177
Fampridine-SR b.i.d.5 participants2.3177
Fampridine-SR b.i.d.10 participants8.5177
Fampridine-SR b.i.d.66 participants38.4177
Fampridine-SR b.i.d.100 participants47.5177

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Fampridine-SR b.i.d. (Twice Daily)17765 (36.7%)

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).

    over 7 years (2004-2011)

    Nerve conduction testsSafety

Other measures (4)

  • Timed 25 Foot Walk (T25FW)

    Screening visit, visit 4, every 12 weeks thereafter, Last Regular Visit, Follow Up Visit and Early Termination Visit

    Disability progressionWalking and mobility

  • Subject 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

* The subject must have been previously enrolled in an Acorda Therapeutics or an Elan Corporation sponsored study for multiple sclerosis and received either Fampridine or placebo. * The subject must have multiple sclerosis as determined by the Principal Investigator. * The subject, male or female, 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. * The subject must be of adequate cognitive function, as judged by the Investigator. * Any subject who is female and of childbearing potential, regardless of sexual activity, must have a negative urine pregnancy test at the Screening Visit.

Exclusion criteria

* The subject is a female who is either pregnant or breastfeeding, or of child-bearing potential, who, if engaged in active heterosexual relations and has not had a hysterectomy or bilateral oophorectomy, would not use one of the following birth control methods: tubal ligation, implantable contraception device, oral, injectable or transdermal contraceptive, barrier method or sexual activity restricted to vasectomized partner. * The subject withdrew from a previous Fampridine study because of a Serious Adverse Event that was possibly, probably or definitely related to Fampridine. * The subject has a history of seizures or has evidence of past, or possible, epileptiform activity on an EEG. * The subject has either a clinically significant abnormal ECG or laboratory value(s) at the Screening Visit, as judged by the Investigator * The subject has angina, uncontrolled hypertension, clinically significant cardiac arrhythmias, or any other clinically significant cardiovascular abnormality, as judged by the Investigator. * The subject has a known allergy to pyridine-containing substances or any of the inactive ingredients of the Fampridine tablet * The subject has received an investigational drug, except for Fampridine- SR (or matching placebo) under Protocol MS-F202, within 30 days prior to the Screening Visit; or the subject is scheduled to enroll in an investigational drug trial at any time during this study. * The subject has received compounded 4-aminopyridine (4-AP) within 14 days of the Screening Visit. * The subject has had an onset of an MS exacerbation within 30 days prior to the Screening Visit, or, if in the judgment of the Investigator, has not stabilized from a prior exacerbation episode. * The subject has started on a concomitant medication regimen for an underlying disease/symptom within the past 7 days; or has started an interferon or chemotherapeutic agent for multiple sclerosis within the past 4 weeks. * The 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 long-term safety, tolerability and activity of Fampridine-SR in subjects with multiple sclerosis who have previously participated in either an Acorda Therapeutics or an Elan Corporation sponsored protocol. Subjects are eligible regardless of whether they received active drug or placebo during their participation in the previous study.

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Linked trials

Links found where a registry record names another trial's registry number.

Related trials

History

    1. Started

      Nov 2003

    2. Main results due

      Jan 2011

    3. Finished

      Apr 2011

    4. Results posted

      Feb 2012

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