Safety and Efficacy of Sustained Release Dalfampridine in Transverse Myelitis (Re-Launch)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02166346
• Date of registration: 16/06/2014
• Prospective Registration: No
• Primary sponsor: Johns Hopkins University
• Public title: Safety and Efficacy of Sustained Release Dalfampridine in Transverse Myelitis (Re-Launch)
• Scientific title: Double-Blind, Placebo-Controlled Crossover Trial on the Safety and Efficacy of Sustained-Release Dalfampridine in Transverse Myelitis (Re-Launch)
• Date of first enrolment: February 2014
• Target sample size: 24
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02166346
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Michael Levy, MD, PhD
• Affiliation: Johns Hopkins University

Key inclusion & exclusion 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).



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Myelitis NOS

Idiopathic Transverse Myelitis

Neuromyelitis Optica

Transverse Myelitis

Intervention(s)

Drug: Placebo

Drug: Dalfampridine

Primary Outcome(s)

Walking Speed During Timed 25-foot Walk [Time Frame: Every 2 weeks during each 8 week intervention]

Secondary Outcome(s)

Upper and Lower Extremity Muscle Strength Measurements [Time Frame: baseline and end (8 weeks) of each intervention]

Secondary ID(s)

NA_00090799

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Acorda Therapeutics

Results

• Results available: Yes
• Date Posted: 17/04/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02166346