Phase 4
N=716
A Long-term Efficacy, Safety, and Tolerability Study of BOTOX® in Patients With Chronic Migraine
Migraine Disorders
Bottom Line
View on ClinicalTrials.gov: NCT01516892 ↗Enrolled (actual)
716
Serious AEs
10.5%
Results posted
Jan 2017
Primary outcome: Primary: Change From Baseline in the Frequency of Headache Days — 22.0; -10.7 headache days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- onabotulinumtoxinA (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Frequency of Headache Days |
22.0; -9.2 | — |
| SECONDARY Change From Baseline in the Frequency of Headache Days |
22.0; -9.2 | — |
| SECONDARY Change From Baseline in Headache Impact Test Questionnaire (HIT-6) Total Score |
64.7; -6.8; -7.1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer)
Exclusion Criteria
- Diagnosis of myasthenia gravis, Eaton-Lambert Syndrome, or amyotrophic lateral sclerosis
- Headache attributed to another disorder
- Infection or skin disorder at injection sites
- Previous treatment with botulinum toxin of any serotype for any reason
- Anticipated need for botulinum toxin of any type for any reason during the course of the study
- Previous participation in any botulinum toxin clinical trial
Data sourced from ClinicalTrials.gov (NCT01516892). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.