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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Yale University.
Recruitment status was  Recruiting
Information provided by:
Yale University Identifier:
First received: April 10, 2008
Last updated: August 3, 2011
Last verified: August 2011
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.

Condition Intervention Phase
Refractory Migraine
Drug: Botulinum toxin A
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Investigation of Efficacy and Safety of Botulinum Toxin A (Botox-Allergan Inc) in Migraine Headaches

Resource links provided by NLM:

Further study details as provided by Yale University:

Primary Outcome Measures:
  • 1- Pain Intensity (VAS) 2- Pain frequency [ Time Frame: Quality of life (HIT-6) and MSQ ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
arm 1: compares the effect of Botox with placebo (blinded protocol)
Drug: Botulinum toxin A
Series of injections of botulinum toxin totalling 200 to 300 units vs placebo. Final dose is determined by based size of patient and patient neck size.
Other Name: Botox.
Active Comparator: 2
Arm 2- Open label- every subject receives Botox
Drug: Botulinum toxin A
Open label arm with injection of active drug via a series of injections as used in Arm 1 (closed label). A series of intramuscular injections totalling 200 to 300 units of toxin administered.
Other Name: Botox.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00660192

Contact: Diana Richardson, M.D. (203) 737-1831
Contact: Laura Marshall (203) 785-5420

United States, Connecticut
Yale Neurology Clinic, 6C, 40 Temple Street Recruiting
New Haven, Connecticut, United States, 06520
Principal Investigator: Bahman Jabbari, M.D         
Principal Investigator: Bahman Jabbari, M.D.         
Sponsors and Collaborators
Yale University
Principal Investigator: Bahman Jabbari, M.D. Yale University
  More Information

No publications provided

Responsible Party: Bahman Jabbari, Professor of Neurology, Yale University School of Medicne Identifier: NCT00660192     History of Changes
Other Study ID Numbers: 0709003056 
Study First Received: April 10, 2008
Last Updated: August 3, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Migraine, refractory migraine, Pain, Botulinum Toxin , Botox

Additional relevant MeSH terms:
Botulinum Toxins
Botulinum Toxins, Type A
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
Anti-Dyskinesia Agents
Central Nervous System Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on February 07, 2016