CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 33 enrolled
Drug / intervention
Botoxdrug
Likely dose
Botox 75-150 units, single treatmentAI-extracted
Key inclusion· 4
  • ✓Spasticity resulting from stroke, vascular malformation, or traumatic brain injury
  • ✓Ashworth Score (resting) of at least 2 in the primary ankle plantarflexor (gastrocnemius)
  • ✓Primary illness onset at least 6 months before enrollment
  • ✓Age at least 12 years
Key exclusion· 7
  • ✕Hypersensitivity or allergy to botulinum toxin
  • ✕History of myasthenia gravis or other neuromuscular disease
  • ✕Current use of aminoglycosides
  • ✕Prior botulinum toxin or phenol injection to study limb within 6 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00178646
NCT00178646Phase 4Completed
CompareCT.gov

Comparative Efficacy of Three Preparations of Botox-A in Treating Spasticity

The University of Texas Health Science Center, Houston·interventional·Posted Sep 15, 2005·Updated Jan 22, 2021

In Brief

A Phase 4 clinical trial evaluating Botox for Stroke and 2 related conditions. Completed, enrolled 33 participants across 2 sites.

Detailed Summary

The study seeks to compare the effectiveness of three preparations of BOTOX-A® in treating muscle tightness and spasms in the feet and ankles of people with stroke.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStroke, Brain Injuries, Spasticity
CountriesUnited States
CollaboratorsAllergan

Timeline

Phase 4CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 15, 2005
Enrollment StartJan 1, 2002
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 8.2 yearsPosted 20.8 years ago

Interventions

Botoxdrug

Botox 75-150 units, single treatment only