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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00660192
First received: April 10, 2008
Last updated: February 15, 2016
Last verified: February 2016
  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%.

Condition Intervention Phase
Refractory Migraine
Drug: Botox
Other: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel 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:
  • Mean Number of Days of Decrease in Pain Level Using VAS [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Number of days of decreased pain (2 grades or more) on Visual Analog scale. VAS ranges from 0-10, with 0 being no pain, and 10 being worst pain.


Secondary Outcome Measures:
  • Number of Participants Satisfied With Treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    Number of Patients whose Patient global impression of change (PGIC) moderately or much improved- The PGIC is a 7 point scale that requires the clinician to assess how much the patient's pain has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as:

    No change (or condition has gotten worse) (1) Almost the same, hardly any change at all (2) A little better, but no noticeable change (3) Somewhat better, but the change has not made any real difference (4) Moderately better, and a slight but noticeable change (5) Better and a definite improvement that has made a real and worthwhile difference (6) A great deal better and a considerable improvement that has made all the difference (7)improved

    This outcome is number of patients who chose a 6 or above on the PGIC 6 weeks after treatment.



Enrollment: 25
Study Start Date: January 2008
Study Completion Date: July 2015
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Subjects are randomized to receive Placebo which is inactive saline (sterile salt water solution). The Subjects are injected with a comparable amount of placebo solution (2cc-3cc) as received by those randomized to receive active study drug. The randomization will be done in a double blinded manner where the investigator nor the subject knows which substance (Placebo vs. Botox) is being injected.
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.
Other Name: Saline
Active Comparator: Botox
Subjects are randomized to receive Active study drug Botox (onobotulinumtoxinA). The Botox is prepare by diluting 100units of toxin /1cc Saline. The Subjects are injected with 200-300units of units of Botox which is 2cc-3cc of solution. The randomization will be done in a double blinded manner where the investigator nor the subject knows which substance (Placebo vs. Botox) is being injected.
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 Name: onobotulinumtoxinA

Detailed Description:
Contact PI for study details
  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

Locations
United States, Connecticut
Yale Physician's Building, 800 Howard Ave, lower level,
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Bahman Jabbari, M.D. Yale- 203-737-2464
  More Information

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00660192     History of Changes
Other Study ID Numbers: 0709003056 
Study First Received: April 10, 2008
Results First Received: August 18, 2014
Last Updated: February 15, 2016
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
AbobotulinumtoxinA
Botulinum Toxins
Botulinum Toxins, Type A
IncobotulinumtoxinA
OnabotulinumtoxinA
Acetylcholine Release Inhibitors
Cholinergic Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neuromuscular Agents
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 26, 2016