Safety and Efficacy of Sustained Release Dalfampridine in Transverse Myelitis (Re-Launch)
Condition: Transverse Myelitis; Neuromyelitis Optica; Idiopathic Transverse Myelitis; Myelitis NOS
MeSH terms: Myelitis; Myelitis, Transverse; Neuromyelitis Optica
Intervention: Dalfampridine; Placebo
Intervention description: Dalfampridine 10 mg twice daily for 8 weeks; Placebo pill 1 tablet twice daily for 8 weeks
Intervention MeSH terms: 4-Aminopyridine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Transverse myelitis

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).