N/A
N=1,168
BOTOX® Prophylaxis in Patients With Chronic Migraine
Migraine Disorders
Bottom Line
View on ClinicalTrials.gov: NCT01432379 ↗Enrolled (actual)
1,168
Serious AEs
5.3%
Results posted
Dec 2016
Primary outcome: Primary: Incidence Rate of Dysphagia — 0.4 events per 1,000 person-months
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- botulinum toxin Type A (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence Rate of Dysphagia |
0.4 | — |
| SECONDARY Incidence Rate of Intractable Migraine |
1.6 | — |
Summary
This is a post authorization observational study to monitor the utilization practices and describe the safety profile of BOTOX® in clinical practice for the prophylactic treatment of headaches in adult patients with chronic migraine.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of chronic migraine
- Willing to use BOTOX® as preventative treatment for migraine
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT01432379). 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.