Phase 3
Completed N=679
A Study Using Botulinum Toxin Type A as Headache Prophylaxis for Migraine Patients With Frequent Headaches
Migraine Disorders
Source: ClinicalTrials.gov NCT00156910 ↗
Enrolled (actual)
679
Serious AEs
5.2%
Results posted
Dec 2010
Primary outcomePrimary: Change in Frequency of Headache Episodes — 12.3; 13.4; -5.2; -5.3 Headache Episodes
Summary
This is a 60 week study including a double-blind phase followed by an open-label extension phase.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Frequency of Headache Episodes |
12.3; 13.4; -5.2; -5.3 | — |
| SECONDARY Change in Frequency of Headache Days |
20.0; 19.8; -7.8; -6.4 | — |
| SECONDARY Change in Frequency of Acute Headache Pain Medication Intakes |
29.1; 30.4; -10.3; -10.4 | — |
| SECONDARY Change in Frequency of Migraine/Probable Migraine Headache Days |
19.1; 19.1; -7.6; -6.1 | — |
| SECONDARY Change in Frequency of Migraine/Probable Migraine Headache Episodes |
11.5; 12.7; -4.8; -4.9 | — |
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 Temporomandibular Disorders (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 (NCT00156910). 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.