At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 125 enrolled
Drug / intervention
Botulinum toxin type A Dose 1 +2 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.
191622-103 BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex as Headache Prophylaxis in Adolescents (Children 12 to < 18 Years of Age) With Chronic Migraine
In Brief
A Phase 3 clinical trial evaluating Botulinum toxin type A Dose 1, Botulinum toxin type A Dose 2, and 1 other intervention for Migraine Disorders. Completed, enrolled 125 participants across 22 sites.
Detailed Summary
To evaluate the efficacy and safety of Botulinum Toxin Type A versus placebo (normal saline) as headache prophylaxis in adolescents (children 12 to 17) with chronic migraine.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine Disorders
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 2012
Enrollment StartOct 2012
Primary CompletionAug 2016
TodayJul 2026
First PostedAug 10, 2012
Enrollment StartOct 1, 2012
Primary CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 13.9 years ago
Interventions
Botulinum toxin type A Dose 1biological
Botulinum toxin type A Dose 1 intramuscular injections into specified muscles.
Botulinum toxin type A Dose 2biological
Botulinum toxin type A Dose 2 intramuscular injections into specified muscles.
Placebo (Normal Saline)drug
Placebo (Normal Saline) intramuscular injections into specified muscles.