Investigation of Efficacy and Safety of Botulinum Toxin A (Botox-Allergan Inc) in Migraine Headaches
Information source: Yale University
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Refractory Migraine
Intervention: Botulinum toxin A (Drug); Botulinum toxin A (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Yale University Official(s) and/or principal investigator(s):
Bahman Jabbari, M.D., Principal Investigator, Affiliation: Yale University
Overall contact:
Diana Richardson, M.D., Phone: (203) 737-1831, Email: diana.richardson@yale.edu
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% and more and this effect is even more positive after
second treatment.
Clinical Details
Official title: Investigation of Efficacy and Safety of Botulinum Toxin A (Botox-Allergan Inc) in Migraine Headaches
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: 1- Pain Intensity (VAS) 2- Pain frequency
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Adults 18 and older
- Migraine for more than three months, that fail to respond to two or more major
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
Locations and Contacts
Diana Richardson, M.D., Phone: (203) 737-1831, Email: diana.richardson@yale.edu
Yale Neurology Clinic, 6C, 40 Temple Street, New Haven, Connecticut 06520, United States; Recruiting
Bahman Jabbari, M.D, Principal Investigator
Bahman Jabbari, M.D., Principal Investigator
Additional Information
Starting date: January 2008
Last updated: August 3, 2011
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