At a glance
ClinicalIndex Comparison Record- ✓Frequent migraine with ≥15 headache days per month
- ✓≥4 distinct headache episodes lasting ≥4 hours
- ✓≥50% of baseline headache days are migraine or probable migraine days
- ✕Previous use of botulinum toxin of any serotype or immunization to any botulinum toxin serotype
- ✕Diagnosis of complicated migraine, chronic tension-type headache, hypnic headache, hemicrania continua, or 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
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Study Using Botulinum Toxin Type A as Headache Prophylaxis for Migraine Patients With Frequent Headaches
In Brief
A Phase 3 clinical trial evaluating Botulinum Toxin Type A and Placebo (saline) for Migraine Disorders. Completed, enrolled 679 participants across 2 sites in 2 countries.
Detailed Summary
This is a 60 week study including a double-blind phase followed by an open-label extension phase.
Study Details
Timeline
Interventions
Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.