N/A
Completed N=1,168
BOTOX® Prophylaxis in Patients With Chronic Migraine
Migraine Disorders
Source: ClinicalTrials.gov NCT01432379 ↗
Enrolled (actual)
1,168
Serious AEs
5.3%
Results posted
Dec 2016
Primary outcomePrimary: Incidence Rate of Dysphagia — 0.4 events per 1,000 person-months
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence Rate of Dysphagia |
0.4 | — |
| SECONDARY Incidence Rate of Intractable Migraine |
1.6 | — |
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. Informational only — not medical advice.