At a glance

ClinicalIndex Comparison Record

N/ACompleted· 21 enrolled

Drug / intervention

Botulinum Toxin Type A - OnabotulinumtoxinA +1 moredrug

Likely dose

Botulinum Toxin Type A - OnabotulinumtoxinA 200 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/NCT00661089

NCT00661089N/ACompleted

Compare CT.gov

"A Randomized Double-Blind Placebo-Controlled Trial of Botulinum Toxin Type A (BOTOX ) in the Treatment of Hemiplegic Shoulder Pain and Spasticity"

Shirley Ryan AbilityLab·interventional·Posted Apr 18, 2008·Updated Nov 13, 2020

In Brief

A clinical study evaluating Botulinum Toxin Type A - OnabotulinumtoxinA and Placebo (Saline) for Post-stroke Shoulder Pain and Spasticity. Completed, enrolled 21 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate whether botulinum toxin type A injected into muscles around the shoulder is effective in treating shoulder pain and improving function in patients with shoulder pain and involuntary muscle tightness after a stroke.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsPost-stroke Shoulder Pain and Spasticity

CountriesUnited States

CollaboratorsAllergan

Timeline

N/ACompletedFinished

200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartSep 2003

First PostedApr 2008

Primary CompletionMar 2009

Study CompletionFeb 2010

TodayJul 2026

First PostedApr 18, 2008

Enrollment StartSep 1, 2003

Primary CompletionMar 1, 2009

Study CompletionFeb 1, 2010

TodayJul 2, 2026

Enrollment to primary: 5.5 yearsPosted 18.2 years ago

Interventions

Botulinum Toxin Type A - OnabotulinumtoxinAdrug

100-200 units injected into the pectoralis major. The teres major may also be injected if tone is noted in shoulder extensors.

Placebo (Saline)drug

Equivalent volume of saline without study drug injected into the pectoralis major. Teres major was also injected if tone noted in the shoulder extensors.