CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 317 enrolled
Drug / intervention
IncobotulinumtoxinA (400 Units) +1 moredrug
Likely dose
IncobotulinumtoxinA (400 Units)from 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/NCT01392300
NCT01392300Phase 3Completed
CompareCT.gov

Prospective, Double-blind, Placebo-controlled, Randomized, Multi-center Study With an Open-label Extension Period to Investigate the Efficacy and Safety of NT 201 in the Treatment of Post-stroke Spasticity of the Upper Limb

Merz Pharmaceuticals GmbH·interventional·Posted Jul 12, 2011·Updated Jan 16, 2017

In Brief

A Phase 3 clinical trial evaluating IncobotulinumtoxinA (400 Units) and Placebo Comparator for Post-stroke Spasticity of the Upper Limb. Completed, enrolled 317 participants across 47 sites in 7 countries.

Detailed Summary

The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the upper limb are effective in treating spasticity in patients after stroke.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPost-stroke Spasticity of the Upper Limb
CountriesCzechia, Germany, Hungary, India, Poland, Russia, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 12, 2011
Enrollment StartSep 1, 2011
Primary CompletionMar 1, 2013
Study CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 15.0 years ago

Interventions

IncobotulinumtoxinA (400 Units)drug

Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection

Placebo Comparatordrug

Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection