Back to resultsInvestigation of Efficacy and Safety of Botulinum Toxin A (Botox-Allergan Inc) in Migraine Headaches
Primary Purpose
Refractory Migraine
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Botox
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Refractory Migraine focused on measuring Migraine, refractory migraine, Pain, Botulinum Toxin , Botox
Eligibility 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
Sites / Locations
- Yale Physician's Building, 800 Howard Ave, lower level,
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Botox
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Mean Number of Days of Decrease in Pain Level Using VAS
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00660192
Brief Title
Investigation of Efficacy and Safety of Botulinum Toxin A (Botox-Allergan Inc) in Migraine Headaches
Official Title
Investigation of Efficacy and Safety of Botulinum Toxin A (Botox-Allergan Inc) in Migraine Headaches
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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%.
Detailed Description
Contact PI for study details
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Migraine
Keywords
Migraine, refractory migraine, Pain, Botulinum Toxin , Botox
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Botox
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Botox
Other Intervention Name(s)
onobotulinumtoxinA
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean Number of Days of Decrease in Pain Level Using VAS
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Number of Participants Satisfied With Treatment
Description
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.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bahman Jabbari, M.D.
Organizational Affiliation
Yale- 203-737-2464
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale Physician's Building, 800 Howard Ave, lower level,
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Investigation of Efficacy and Safety of Botulinum Toxin A (Botox-Allergan Inc) in Migraine Headaches
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