Phase 2
N=24
Safety and Efficacy of Sustained Release Dalfampridine in Transverse Myelitis (Re-Launch)
Transverse Myelitis · Neuromyelitis Optica · Idiopathic Transverse Myelitis · Myelitis NOS
Bottom Line
View on ClinicalTrials.gov: NCT02166346 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcome: Primary: Walking Speed During Timed 25-foot Walk — 0.3342; 0.4745; 0.4593; 0.1743 feet/second
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dalfampridine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Walking Speed During Timed 25-foot Walk |
0.3342; 0.4745; 0.4593; 0.1743; 0.5445; 0.5697 | — |
| SECONDARY Upper and Lower Extremity Muscle Strength Measurements |
.6420; -0.05187; 2.5774; 2.854; 3.286; -1.497 | — |
Summary
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.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT02166346). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.