CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 16 enrolled
Drug / intervention
Botulinum Toxin commonly known as BOTOX® +1 moredrug
Likely dose
Botulinum Toxin commonly known as BOTOX® 300 unitsfrom 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/NCT01422161
NCT01422161Phase 3Completed
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Botulinum Toxin Type A Therapy as a Plasticity Inducing Agent for Recovery of Hand Function After Stroke

NYU Langone Health·interventional·Posted Aug 23, 2011·Updated Jun 20, 2019

In Brief

A Phase 3 clinical trial evaluating Botulinum Toxin commonly known as BOTOX® and Placebo for Stroke With Hemiparesis. Completed, enrolled 16 participants across 1 site.

Detailed Summary

The purpose of this study is to determine whether injections of botulinum toxin (commonly known as BOTOX®) into the affected hand of Stroke patients, while targeting the muscles controlling the hand, will lead to improved use of the hand when compared to injections of placebo (a substance that looks similar to the study drug but contains no active study medication).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStroke With Hemiparesis
CountriesUnited States
CollaboratorsAllergan

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 23, 2011
Enrollment StartApr 1, 2010
Primary CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 14.9 years ago

Interventions

Botulinum Toxin commonly known as BOTOX®drug

A total dose between 200-300 units of Botulinum toxin will be administered across 12 muscles of the affected hand. There will be 1 treatment cycle during the 9 week study.

Placebodrug

The control group will receive a placebo injection.