CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 52 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.

Search/NCT01833130
NCT01833130Phase 4Completed
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Use of a Treatment Benefit Questionnaire in Patients With Chronic Migraine Treated With OnabotulinumtoxinA (BOTOX®)

Allergan·interventional·Posted Apr 16, 2013·Updated Oct 21, 2015

In Brief

A Phase 4 clinical trial evaluating OnabotulinumtoxinA and Normal saline (placebo) for Chronic Migraine. Completed, enrolled 52 participants across 1 site.

Detailed Summary

This study will evaluate the use of the Assessment of Chronic Migraine Impacts (ACM-I) Questionnaire in assessing the impact and benefit of treatment with onabotulinumtoxinA (BOTOX®) in adults with chronic migraine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Migraine
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 16, 2013
Enrollment StartApr 1, 2013
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 13.2 years ago

Interventions

OnabotulinumtoxinAbiological

OnabotulinumtoxinA (botulinum toxin Type A) 155 U total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.

Normal saline (placebo)drug

Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.