CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
Dalfampridine +1 moredrug
Likely dose
Dalfampridine 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02166346
NCT02166346Phase 2Completed

Double-Blind, Placebo-Controlled Crossover Trial on the Safety and Efficacy of Sustained-Release Dalfampridine in Transverse Myelitis (Re-Launch)

Johns Hopkins University·interventional·Posted Jun 18, 2014·Updated Apr 17, 2018

In Brief

A Phase 2 clinical trial evaluating Dalfampridine and Placebo for Transverse Myelitis and 3 related conditions. Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsAcorda Therapeutics

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 18, 2014
Enrollment StartFeb 1, 2014
Primary CompletionJan 8, 2017
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 12.0 years ago

Interventions

Dalfampridinedrug

Dalfampridine 10 mg twice daily for 8 weeks

Placebodrug

Placebo pill 1 tablet twice daily for 8 weeks