Phase 3
Completed N=705
A Study Using Botulinum Toxin Type A as Headache Prophylaxis for Migraine Patients With Frequent Headaches
Migraine Disorders
Source: ClinicalTrials.gov NCT00168428 ↗
Enrolled (actual)
705
Serious AEs
4.0%
Results posted
Dec 2010
Primary outcomePrimary: Change in Frequency of Headache Days — 19.9; 19.7; -9.0; -6.7 Headache Days
Summary
This is a 60 week study including a double-blind phase followed by an open-label phase.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Frequency of Headache Days |
19.9; 19.7; -9.0; -6.7 | — |
| SECONDARY Change in Total Cumulative Hours of Headache Occurring on Headache Days |
296.18; 287.20; -132.41; -90.01 | — |
| SECONDARY Change in Frequency of Moderate/Severe Headache Days |
18.1; 17.7; -8.3; -5.8 | — |
| SECONDARY Change in Frequency of Migraine/Probable Migraine Headache Days |
19.2; 18.7; -8.7; -6.3 | — |
| SECONDARY Change in Frequency of Headache Episodes |
12.0; 12.7; -5.3; -4.6 | — |
| SECONDARY Percentage of Patients With Severe HIT-6 Impact Category Scores |
66.3; 76.5 | — |
Eligibility Criteria
Inclusion Criteria
- Frequent migraine (>=15 headache days per month)
- >=4 distinct headache episodes lasting >=4 hours
- >=50% of baseline headache days migraine/probable migraine days
Exclusion Criteria
- Previous use of botulinum toxin of any serotype or immunization to any botulinum toxin serotype
- Any medical condition that puts the patient at increased risk with exposure to BOTOX
- Diagnosis of complicated migraine, chronic tension-type headache, hypnic headache, hemicrania continua, new daily persistent headache
- Use of prophylactic headache medication within 28 days prior to week -4
- Unremitting headache lasting continuously throughout the 4-week baseline period
- Known or suspected TMD
- Diagnosis of fibromyalgia
- Beck depression inventory score >24 at week-4
- Psychiatric problems that may have interfered with study participation
Data sourced from ClinicalTrials.gov (NCT00168428). 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.