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NCT01444300 · ClinicalTrials.gov registry record · Phase 2

Dalfampridine for Imbalance in Multiple Sclerosis

A Phase 2 study, sponsored by Oregon Health and Science University.

Completed
Registry status
Phase 2
Development phase
24
Enrollment target

NCT01444300: Completed Phase 2 study, sponsored by Oregon Health and Science University.

NCT01444300 is a Phase 2 study that has completed, run by Oregon Health and Science 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

NCT01444300, a Phase 2 study, has completed, sponsored by Oregon Health and Science University.

COMPLETED
Registry status
Phase 2
Development phase
24 participants
Enrollment target

Study Summary

Dalfampridine is a new medication that was FDA approved in 2010 to improve walking speed in people with Multiple Sclerosis (MS). People with MS walk slowly in part because MS damages the myelin insulation around nerves which slows conduction of messages from the brain to the leg muscles. Dalfampridine works by improving conduction in nerves with damaged myelin. Recent research indicates that imbalance in MS is in large part caused by poor conduction by the nerves that transmit information about the position of the legs to the brain. It is therefore likely that, by improving nerve conduction, dalfampridine will also improve imbalance in people with MS. Dalfampridine will be administered in this study by the same route (oral), dosage (10mg), and frequency (every 12 hours) approved by the FDA to improve walking speed in people with MS. The proposed pilot study will examine the effects of dalfampridine on imbalance in 24 subjects with Multiple Sclerosis (MS) and imbalance. This small pilot study will help to show if dalfampridine improves imbalance in MS and will guide the design and implementation of a larger full scale study to definitively determine if dalfampridine improves balance and prevents falls in people with MS.

Primary Outcome

Automatic Postural Response (APR) latencies will be measured by Computerized Dynamic Posturography (CDP). The restoration of balance after an unexpected movement by Computerized Dynamic Posturography relies on automated postural responses in the upper and lower legs, trunk, shoulders, and neck muscles. APR latency is the reaction- time response to movements of the support surface on which the subject stands. These responses typically occur at onset latencies of \~100 milliseconds. In response to

Interventions

  • DRUG Placebo
  • DRUG Dalfampridine

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2011-09
Est. Completion 2013-09
Phase Phase 2

What the finished NCT01444300 record still lists

NCT01444300 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.

NCT01444300 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01444300 about?

NCT01444300 is a clinical study titled "Dalfampridine for Imbalance in Multiple Sclerosis". Dalfampridine is a new medication that was FDA approved in 2010 to improve walking speed in people with Multiple Sclerosis (MS). People with MS walk slowly in part because MS damages the myelin insulation around nerves which slows conduction of messages from the brain to the leg muscles. Dalfampridi...

What is the current status of trial NCT01444300?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2011-09. Estimated completion is 2013-09.

What interventions are being tested in trial NCT01444300?

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

Who is sponsoring clinical trial NCT01444300?

This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01444300'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 NCT01444300, the US trial registry maintained by the National Library of Medicine. NCT01444300 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.