Phase 4
Completed N=280
A Safety and Efficacy Study of BOTOX® in Korean Adults With Chronic Migraine
Migraine Disorders
Source: ClinicalTrials.gov NCT02147561 ↗
Enrolled (actual)
280
Serious AEs
1.4%
Results posted
May 2016
Primary outcomePrimary: Percentage of Patients With Adverse Events — 24.37 Percentage of Patients
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study will evaluate the safety and efficacy of BOTOX® treatment in Korean adults with chronic migraine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Adverse Events |
24.37 | — |
| SECONDARY Change From Baseline in Headache Impact Test-6 (HIT-6) Total Score |
67.54; -7.32 | — |
| SECONDARY Physician Global Assessment of Outcome on a 3-Point Scale |
200; 72; 4 | — |
Eligibility Criteria
Inclusion Criteria
- Ethnically Korean with a diagnosis of chronic migraine
Exclusion Criteria
- Anticipated need for botulinum toxin treatment for any reason other than chronic migraine during the study
- Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
Data sourced from ClinicalTrials.gov (NCT02147561). 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.