NCT00660192

Investigation of Efficacy and Safety of Botulinum Toxin A (Botox-Allergan Inc) in Migraine Headaches

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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%.

Detailed description

Contact PI for study details

Conditions

• Refractory Migraine

Interventions

Type	Name	Description
DRUG	Botox	subjects randomized to receive Botox with have a series of injections of onobotulinumtoxinA totalling 200 to 300 units. Botox is prepared b adding 1cc of preservative free saline in 100 unit vial. Final dose is determined by bod and neck size.
OTHER	Placebo	subjects randomized to receive Placebo will have a series of injections of saline solution totalling 2cc's to 3cc's injected into the scalp in a halo pattern; and into affected neck muscles.

Timeline

• Start date: 2008-01-01
• Primary completion: 2012-07-01
• Completion: 2015-07-01
• First posted: 2008-04-17
• Last updated: 2016-03-14
• Results posted: 2016-03-14

Locations

1 site across 1 country: United States