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

NCT02166346 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-04-17

Study results available
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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.

Conditions

  • Transverse Myelitis
  • Neuromyelitis Optica
  • Idiopathic Transverse Myelitis
  • Myelitis NOS

Interventions

DRUG

Dalfampridine

Dalfampridine 10 mg twice daily for 8 weeks

DRUG

Placebo

Placebo pill 1 tablet twice daily for 8 weeks

Sponsors & Collaborators

Principal Investigators

  • Michael Levy, MD, PhD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2017-01-08
Completion
2017-01-08

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02166346 on ClinicalTrials.gov