Phase 3
Completed N=25
Investigation of Efficacy and Safety of Botulinum Toxin A (Botox-Allergan Inc) in Migraine Headaches
Refractory Migraine
Source: ClinicalTrials.gov NCT00660192 ↗
Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcomePrimary: Mean Number of Days of Decrease in Pain Level Using VAS — 1.20; 8.67 days — p=0.0347
Summary
The hypothesis of this study is that injection of botulinum toxin A into the muscles around the head (frontal, temporal, posterior neck, occipital) can reduce the intensity and frequency of migraine headaches by 50%.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Number of Days of Decrease in Pain Level Using VAS |
1.20; 8.67 | 0.0347 sig |
| SECONDARY Number of Participants Satisfied With Treatment |
9; 3 | 0.0300 sig |
Eligibility Criteria
Inclusion Criteria
- Adults 18 and older
- Migraine for more than three months, that fail to respond to two or more major anti-migraine drug, meeting criteria of chronic migraine
Exclusion Criteria
- Age below 18
- Pregnant or may become pregnant
- Disease of neuromuscular junction or drugs that affect N-M junction
- Allergy to Botox
- Previous use of Botox for migraine by similar methodology
Data sourced from ClinicalTrials.gov (NCT00660192). 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.