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

Refractory Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00660192
• Other study ID #: 0709003056
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 10, 2008
• Last updated: February 15, 2016
• Start date: January 2008
• Est. completion date: July 2015

Study information

• Verified date: February 2016
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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%.

Description:

Contact PI for study details

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 2015
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine Disorders
• Refractory Migraine

Intervention

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:
• 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.

Locations

Country	Name	City	State
United States	Yale Physician's Building, 800 Howard Ave, lower level,	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No