N/A
N=641
An Observational Study of BOTOX® as Headache Prophylaxis for Chronic Migraine
Migraine Disorders
Bottom Line
View on ClinicalTrials.gov: NCT01686581 ↗Enrolled (actual)
641
Serious AEs
1.3%
Results posted
Nov 2018
Primary outcome: Primary: Percentage of Participants Admitted to the Hospital for Headache — 6.0; 2.1 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- botulinum toxin Type A (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Admitted to the Hospital for Headache |
6.0; 2.1 | — |
| PRIMARY Mean Number of Days of Headache-related Hospital Admissions |
8.9; 4.8 | — |
| PRIMARY Percentage of Participants Who Visited Any Healthcare Professional (HCP) |
45.8; 17.1; 30.6; 12.7; 33.3; 6.8 | — |
| SECONDARY Change From Baseline in Migraine-Specific Quality of Life Questionnaire (MSQ) Score |
37.14; 25.71; 50.0; 20.00; 40.00; 26.67 | — |
| SECONDARY Change From Baseline in the EQ-5D Questionnaire Total Score |
0.69; 0.107 | — |
| SECONDARY Change From Baseline in the Health State Score of the EQ-5D Questionnaire |
50.0; 10.0 | — |
| SECONDARY Change From Baseline in the Number of Headache Days |
20.0; -11.0 | — |
| SECONDARY Percentage of Participants With Good or Very Good Responses on the 4-Point Treatment Satisfaction Scale |
78.1; 76.0 | — |
Summary
This is an observational study to describe the long term use of Onabotulinumtoxin A (BOTOX®) as prescribed by the physician for headache prophylaxis in adults with chronic migraine. All treatment decisions lie with the physician.
Eligibility Criteria
Inclusion Criteria
- Prescribed BOTOX® for the prophylaxis of headaches.
Exclusion Criteria
- Received treatment with any botulinum toxin Type A serotype in the last 26 weeks
- Current participation in Allergan's Botox Chronic Migraine Post-Authorisation Safety Study (protocol 191622-110).
Data sourced from ClinicalTrials.gov (NCT01686581). 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.