CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 716 enrolled
Drug / intervention
onabotulinumtoxinAbiological
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.

Search/NCT01516892
NCT01516892Phase 4Completed
CompareCT.gov

A Long-term Efficacy, Safety, and Tolerability Study of BOTOX® in Patients With Chronic Migraine

Allergan·interventional·Posted Jan 25, 2012·Updated Jan 6, 2017

In Brief

A Phase 4 clinical trial evaluating onabotulinumtoxinA for Migraine Disorders. Completed, enrolled 716 participants across 32 sites in 3 countries.

Detailed Summary

This open-label study will assess the long-term efficacy, safety, and tolerability of onabotulinumtoxinA administered for prophylaxis of headaches in patients with chronic migraine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine Disorders
CountriesAustralia, South Korea, United States
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 25, 2012
Enrollment StartDec 1, 2011
Primary CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 14.4 years ago

Interventions

onabotulinumtoxinAbiological

Participants received 155 U of onabotulinumtoxinA approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.