CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 468 enrolled
Drug / intervention
botulinum toxin Type A +1 morebiological
Likely dose
Not stated in 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/NCT01575054
NCT01575054Phase 3Completed
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BOTOX® Treatment in Adult Patients With Post-Stroke Lower Limb Spasticity

Allergan·interventional·Posted Apr 11, 2012·Updated Sep 28, 2016

In Brief

A Phase 3 clinical trial evaluating botulinum toxin Type A and Normal Saline for Muscle Spasticity. Completed, enrolled 468 participants across 12 sites in 9 countries.

Detailed Summary

This study will evaluate the safety and efficacy of BOTOX® in the treatment of adult post-stroke lower limb spasticity.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMuscle Spasticity
CountriesCanada, Czechia, Germany, Hungary, Poland, Russia, South Korea, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 11, 2012
Enrollment StartMay 1, 2012
Primary CompletionSep 1, 2014
Study CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 14.2 years ago

Interventions

botulinum toxin Type Abiological

Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.

Normal Salinedrug

Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles.