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
Sponsor:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00660192
First received: April 10, 2008
Last updated: August 3, 2011
Last verified: August 2011
  Purpose

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT00660192

Contacts
Contact: Diana Richardson, M.D. (203) 737-1831 diana.richardson@yale.edu
Contact: Laura Marshall (203) 785-5420 laura.marshall@yale.edu

Locations
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
Investigators
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
ClinicalTrials.gov 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:
Headache
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014