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

Study Overview
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Brief Summary
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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
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Contact PI for study details

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

Conditions
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Refractory Migraine

Intervention / Treatment
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* Drug: Botox
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>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<br>* 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.<br>* Other names: Saline;|
| Active Comparator: Botox<br>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<br>* 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.<br>* Other names: onobotulinumtoxinA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine, refractory migraine, Pain, Botulinum Toxin , Botox