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NCT01535664 · ClinicalTrials.gov registry record

An Open Label, Proof of Concept Study to Evaluate the Effects of Dalfampridine Withdrawal on Gait and Balance Parameters in Subjects With Multiple Sclerosis (MS)

A clinical trial, sponsored by Acorda Therapeutics.

Completed
Registry status
20
Enrollment target

NCT01535664: Completed study, sponsored by Acorda Therapeutics.

NCT01535664 is a clinical trial that has completed, run by Acorda Therapeutics. The registered enrollment target is 20 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01535664 has completed, sponsored by Acorda Therapeutics.

COMPLETED
Registry status
20 participants
Enrollment target

Study Summary

The purpose of this study is to determine changes on overall gait as well as in multiple gait and balance parameters after withdrawal of dalfampridine-ER 10mg in MS subjects who are receiving the medication consistently for at least two weeks prior to screening.

Primary Outcome

The co-primary efficacy variable was overall gait. This novel composite score was created from standardized individual NeuroCom test results (Z-scores). ZGAIT (Z-Score Gait) is the average of Walk Across (WA) measuring step width, step length, speed; Tandem Walk (TW) measuring step width, speed and end sway, and Step/Quick turn (SQT) measuring turn time and turn sway). Overall gait was calculated by transforming ZGAIT into a percentile using the standard normal distribution. This rescales the

Interventions

  • OTHER Withdrawal of dalfampridine-ER 10mg

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2012-01
Est. Completion 2012-06
Acorda Therapeutics

36 total trials

What the finished NCT01535664 record still lists

NCT01535664 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which Withdrawal of dalfampridine-ER 10mg is the first listed.

NCT01535664 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01535664 about?

NCT01535664 is a clinical study titled "An Open Label, Proof of Concept Study to Evaluate the Effects of Dalfampridine Withdrawal on Gait and Balance Parameters in Subjects With Multiple Sclerosis (MS)". The purpose of this study is to determine changes on overall gait as well as in multiple gait and balance parameters after withdrawal of dalfampridine-ER 10mg in MS subjects who are receiving the medication consistently for at least two weeks prior to screening.

What is the current status of trial NCT01535664?

This trial is currently completed. The enrollment target is 20 participants. The study started on 2012-01. Estimated completion is 2012-06.

What interventions are being tested in trial NCT01535664?

The interventions under investigation include: Withdrawal of dalfampridine-ER 10mg (OTHER).

Who is sponsoring clinical trial NCT01535664?

This trial is sponsored by Acorda Therapeutics, which has 36 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01535664, the US trial registry maintained by the National Library of Medicine. NCT01535664 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.