CompletedPhase 2NMOSDNCT02166346

What it found

Results posted, no main test reported

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

What was tested

Treatment tested

Placebo or sham

  • Placebo

Results by group

Walking Speed During Timed 25-foot Walk

Every 2 weeks during each 8 week intervention

GroupValueIntervalNumber analysed
Dalfampridine0.3342 feet/second0.0975–0.570913
Placebo0.4745 feet/second0.2294–0.719513
Dalfampridine0.4593 feet/second0.2071–0.711413
Placebo0.1743 feet/second-0.06251–0.411113
Dalfampridine0.5445 feet/second0.1018–0.987213
Placebo0.5697 feet/second0.1596–0.979913
Dalfampridine0.3803 feet/second-0.0113–0.771913
Placebo0.2101 feet/second-0.1757–0.595913

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

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Dalfampridine130 (0.0%)0
Placebo130 (0.0%)0

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

  • Walking Speed During Timed 25-foot Walk

    Every 2 weeks during each 8 week intervention

    Disability progressionWalking and mobility

Other measures (1)

  • Upper and Lower Extremity Muscle Strength Measurements

    baseline and end (8 weeks) of each intervention

    Physical function

Who could take part

NMOSD · 18 to 70

Inclusion Criteria: * Diagnosis of transverse myelitis confirmed by MRI * Gait impairment defined as a baseline timed 25-foot walk of at least 5 seconds and no more than 60 seconds. * Age 18-70. Exclusion Criteria: * Diagnosis of any of the following concurrent conditions: spinal dural arteriovenous malformation, multiple sclerosis, infectious myelitis and recurrent transverse myelitis of any etiology. Subjects with a positive NMO-Immunoglobulin G (IgG) biomarker test will be permitted to join the study as long as the there is only a history of monophasic, and not recurrent, TM. * History of seizure(s). * Pregnancy or positive pregnancy test (mandatory test for all women aged 18-55 to be done at first screening visit). * Known use or allergy to dalfampridine or any other formulation of 4-aminopyridine. * Patients unable to walk. * Patients with history of severe alcohol or drug abuse, severe psychiatric illness such as severe depression, poor motivational capacity, or severe language disturbances, particularly of receptive nature or with serious cognitive deficits (defined as equivalent to a mini-mental state exam score of 23 or less). * Patients with severe uncontrolled medical problems (e.g. hypertension, cardiovascular disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease, claudication, uncontrolled epilepsy or others).

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

Transverse myelitis (TM) is an inflammatory disorder of the spinal cord that leads to disabilities of gait. Dalfampridine, a sustained-release potassium inhibitor has been shown to be effective in improving gait and other neurologic functions in multiple sclerosis. Dalfampridine has the potential to improve neurologic function in patients with transverse myelitis as this rare disorder shares a similar pathogenic process with multiple sclerosis. The in a clinical trial to test the efficacy of dalfampridine in TM. The clinical trial that the investigators propose to conduct will focus on TM and will evaluate the dalfampridine in primary neurologic outcome, 25-foot timed walk, and several secondary outcomes including valid behavioral and neurophysiological tests. This is a re-launch of the previous trial, which now includes additional behavioral and clinical testing.

Papers

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    History

      1. Started

        Feb 2014

      2. Main results due

        Jan 2017

      3. Finished

        Jan 2017

      4. Results posted

        Apr 2018

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