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

Phase 2

Completed

• Conditions: Refractory Migraine
• Interventions: Other: Placebo; Drug: Botox

• Registration Number: NCT00660192
• Lead Sponsor: Yale University

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

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-04-10
• Study First Submitted QC: 2008-04-10
• Study First Posted: 2008-04-17
• Primary Completion: 2012-07
• Results First Submitted: 2014-08-18
• Study Completion: 2015-07
• Status Verified: 2016-02
• Results First Submitted QC: 2016-02-15
• Last Update Submitted: 2016-02-15
• Results First Posted: 2016-03-14
• Last Update Posted: 2016-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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.
Botox	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.

Primary Outcome Measures

Name	Time	Method
Mean Number of Days of Decrease in Pain Level Using VAS	4 weeks	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

Name	Time	Method
Number of Participants Satisfied With Treatment	4 weeks	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.

Trial Locations

Locations (1)

Yale Physician's Building, 800 Howard Ave, lower level,; 🇺🇸 New Haven, Connecticut, United States