CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 216 enrolled
Drug / intervention
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")drug
Likely dose
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins") 5.0 mLfrom 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/NCT00465738
NCT00465738Phase 3Completed
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Prospective, Randomized, Observer-blind, Parallel-group, Multi-center Trial to Assess Efficacy and Safety of Two Different Dilutions of incobotulinumtoxinA (Xeomin) in Patients With Upper Limb Spasticity

Merz Pharmaceuticals GmbH·interventional·Posted Apr 25, 2007·Updated Dec 31, 2010

In Brief

A Phase 3 clinical trial evaluating incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins") for Upper Limb Spasticity. Completed, enrolled 216 participants across 27 sites in 8 countries.

Detailed Summary

This study will investigate the efficacy and safety of incobotulinumtoxinA (Xeomin) in the treatment of arm tightness (upper limb spasticity) using two different dilutions of incobotulinumtoxinA (Xeomin).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUpper Limb Spasticity
CountriesAustria, France, Germany, Italy, Portugal, Spain, Switzerland, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 25, 2007
Enrollment StartFeb 1, 2007
Primary CompletionJan 1, 2008
Study CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 19.2 years ago

Interventions

incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")drug

active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins; powder for solution for injection; Mode of administration: intramuscular injection; The content of the vial was dissolved in 2.0 or 5.0 mL of sterile sodium chloride \[NaCl\] 0.9% solution without preservatives. Dilution with 2.0 or 5.0 mL resulted in a dose of 50 or 20 units per 1.0 mL.