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

What is the purpose of this trial?

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% and more and this effect is even more positive after second treatment.

Dates: January 2008 - December 2009
Study Status: Recruiting

Who can participate?

Ages Eligible: 18 Years and older
Gender Eligible: Both

Inclusion Criteria

  • Adults 18 and older
  • Anti-migraine drug, meeting criteria of chronic migraine

Exclusion Criteria

  • Age below 18
  • Pregnant or may become pregnant
  • Disease of neuromuscular junction or drugs that affect N-M junction
  • Allergy to Botox
  • Previous use of Botox for migraine by similar methodology

Sponsor: Yale University
Phase: Phase 3
Clinicaltrials.gov ID: NCT00660192
Study HIC # 0709003056

For more information about this trial, contact

Diana Richardson, M.D.
(203) 737-1831
diana.richardson@yale.edu

Yale Researcher
Jabbari, Bahman
Principal Investigator