At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 150 enrolled
Drug / intervention
OnabotulinumtoxinA +1 morebiological
Likely dose
Not stated in 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.
BOTOX® (onabotulinumtoxinA) Treatment of Masseter Muscle Prominence: A Phase 2b, Multicenter, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study
In Brief
A Phase 2 clinical trial evaluating OnabotulinumtoxinA and Normal saline for Masseter Muscle Prominence. Completed, enrolled 150 participants across 14 sites.
Detailed Summary
Based on the results of the Phase 2 Study 191622-130 \[NCT02010775\], the current Phase 2b study is designed to further evaluate the safety and efficacy of BOTOX® for the treatment of Masseter Muscle Prominence (MMP) in adults.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMasseter Muscle Prominence
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedMar 2019
Enrollment StartMay 2019
Primary CompletionApr 2020
Study CompletionJul 2020
TodayJul 2026
First PostedMar 5, 2019
Enrollment StartMay 16, 2019
Primary CompletionApr 3, 2020
Study CompletionJul 2, 2020
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 7.3 years ago
Interventions
OnabotulinumtoxinAbiological
OnabotulinumtoxinA (botulinum toxin Type A;BOTOX®) administered intramuscularly to the bilateral masseter muscles on Day 1.
Normal salinedrug
Normal saline (placebo) administered intramuscularly to the bilateral masseter muscles on Day 1.