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NCT02166346 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Johns Hopkins University.

Completed
Registry status
Phase 2
Development phase
24
Enrollment target

NCT02166346: Completed Phase 2 study, sponsored by Johns Hopkins University.

NCT02166346 is a Phase 2 study that has completed, run by Johns Hopkins University. The registered enrollment target is 24 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02166346, a Phase 2 study, has completed, sponsored by Johns Hopkins University.

COMPLETED
Registry status
Phase 2
Development phase
24 participants
Enrollment target

Study 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.

Primary Outcome

In this cross-over study, walking speed was recorded 4 times for each subject while in both the dalfampridine and placebo arms. The results average all of the times while on damfampridine and compares them to the average of the times while on placebo.

Interventions

  • DRUG Placebo
  • DRUG Dalfampridine

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2014-02
Est. Completion 2017-01-08
Phase Phase 2
Johns Hopkins University

1,448 total trials

What the finished NCT02166346 record still lists

NCT02166346 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT02166346 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02166346 about?

NCT02166346 is a clinical study titled "Safety and Efficacy of Sustained Release Dalfampridine in Transverse Myelitis (Re-Launch)". 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...

What is the current status of trial NCT02166346?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2014-02. Estimated completion is 2017-01-08.

What interventions are being tested in trial NCT02166346?

The interventions under investigation include: Placebo (DRUG), Dalfampridine (DRUG).

Who is sponsoring clinical trial NCT02166346?

This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02166346's enrollment target sits among peer trials

24 1756th of 2000 higher than 217 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02166346, the US trial registry maintained by the National Library of Medicine. NCT02166346 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.