Re-Launch
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
Placebo or sham
- Placebo
Results by group
Walking Speed During Timed 25-foot Walk
Every 2 weeks during each 8 week intervention
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Dalfampridine | 0.3342 feet/second | 0.0975–0.5709 | 13 |
| Placebo | 0.4745 feet/second | 0.2294–0.7195 | 13 |
| Dalfampridine | 0.4593 feet/second | 0.2071–0.7114 | 13 |
| Placebo | 0.1743 feet/second | -0.06251–0.4111 | 13 |
| Dalfampridine | 0.5445 feet/second | 0.1018–0.9872 | 13 |
| Placebo | 0.5697 feet/second | 0.1596–0.9799 | 13 |
| Dalfampridine | 0.3803 feet/second | -0.0113–0.7719 | 13 |
| Placebo | 0.2101 feet/second | -0.1757–0.5959 | 13 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Dalfampridine | 13 | 0 (0.0%) | 0 |
| Placebo | 13 | 0 (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
Loading reviews and guidelines…
Related trials
- Assessment of fampridine-PR in NMO
Phase 4 · Completed
No result found
History
Started
Feb 2014
Main results due
Jan 2017
Finished
Jan 2017
Results posted
Apr 2018
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