CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 71 enrolled
Drug / intervention
OnabotulinumtoxinA Injectable Product +2 moredrug
Likely dose
Not stated in record
Key inclusion· 1
  • ✓Diagnosis of facial synkinesis
Key exclusion· 4
  • ✕Previous complication from botulinum toxin neuromodulator injection
  • ✕Inability to understand or complete the SAQ survey
  • ✕Inability to participate in follow-up
  • ✕Pregnancy

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

Search/NCT03048383
NCT03048383Phase 4Completed
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Randomized, Single-blind Comparison of Three Commercially Available Botulinum Neuromodulators in the Management of Facial Synkinesis

University of Utah·interventional·Posted Feb 9, 2017·Updated Jul 31, 2017

In Brief

A Phase 4 clinical trial evaluating OnabotulinumtoxinA Injectable Product, AbobotulinumtoxinA Injectable Product, and 1 other intervention for Facial Nerve Injuries and 3 related conditions. Completed, enrolled 71 participants.

Detailed Summary

The purpose of this study is to compare the effectiveness of three commercially available botulinum toxin neuromodulators in the treatment of facial synkinesis using patient reported outcome measures.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFacial Nerve Injuries, Facial Paresis Associated With Facial Nerve Dysfunction, Facial Asymmetry, Synkinesis
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 9, 2017
Enrollment StartJul 1, 2012
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 9.4 years ago

Interventions

OnabotulinumtoxinA Injectable Productdrug

Administered to treat facial synkinesis

AbobotulinumtoxinA Injectable Productdrug

Administered to treat facial synkinesis

Incobotulinumtoxin A Injectable Productdrug

Administered to treat facial synkinesis