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

February 15, 2016 updated by: Yale University
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%.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Contact PI for study details

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale Physician's Building, 800 Howard Ave, lower level,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • onobotulinumtoxinA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Number of Days of Decrease in Pain Level Using VAS
Time Frame: 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.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Satisfied With Treatment
Time Frame: 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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Principal Investigator: Bahman Jabbari, M.D., Yale- 203-737-2464

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

April 10, 2008

First Submitted That Met QC Criteria

April 10, 2008

First Posted (Estimate)

April 17, 2008

Study Record Updates

Last Update Posted (Estimate)

March 14, 2016

Last Update Submitted That Met QC Criteria

February 15, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0709003056

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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