CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 155 enrolled
Drug / intervention
IncobotulinumtoxinAdrug
Likely dose
IncobotulinumtoxinA 400 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/NCT01603459
NCT01603459Phase 3Completed
CompareCT.gov

Prospective, Open-label, Non-randomized, Single-arm, Multi-center Dose Titration Study to Investigate the Safety and Efficacy of NT 201 in Subjects Deemed to Require Total Body Doses of 800 U of NT 201 During the Course of the Study for the Treatment of Upper and Lower Limb Spasticity of the Same Body Side Due to Cerebral Causes

Merz Pharmaceuticals GmbH·interventional·Posted May 22, 2012·Updated Apr 26, 2017

In Brief

A Phase 3 clinical trial evaluating IncobotulinumtoxinA for Spasticity of the Upper and Lower Limb Due to Cerebral Causes. Completed, enrolled 155 participants across 33 sites in 8 countries.

Detailed Summary

The purpose of this study is to determine whether injections with increasing doses (up to 800 units) of Botulinum toxin type A into muscles of the leg and/or arm are safe and effective in treating patients with spasticity on one body side due to cerebral causes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpasticity of the Upper and Lower Limb Due to Cerebral Causes
CountriesCanada, France, Germany, Italy, Norway, Portugal, Spain, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 22, 2012
Enrollment StartMay 1, 2012
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 14.1 years ago

Interventions

IncobotulinumtoxinAdrug

Subjects to receive up to 3 injection cycle, with the dose titrated from 400 units to up to 800 units. For each injection session: solution prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400-800 units, volume 2.0 mL per 100 units; Mode of administration: intramuscular injection.