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

• ClinicalTrials.gov Identifier: NCT00660192
• Recruitment Status: Completed
• First Posted: April 17, 2008
• Results First Posted: March 14, 2016
• Last Update Posted: March 14, 2016
• Sponsor: Yale University
• Information provided by (Responsible Party): Yale University

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%.

Condition or disease	Intervention/treatment	Phase
Refractory Migraine	Drug: Botox; Other: Placebo	Phase 2; Phase 3

Detailed Description:

Contact PI for study details

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Investigation of Efficacy and Safety of Botulinum Toxin A (Botox-Allergan Inc) in Migraine Headaches
• Study Start Date: January 2008
• Actual Primary Completion Date: July 2012
• Actual Study Completion Date: July 2015

Arms and Interventions

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 Name: 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 Name: onobotulinumtoxinA

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Connecticut

Yale Physician's Building, 800 Howard Ave, lower level,

New Haven, Connecticut, United States, 06510

Sponsors and Collaborators

Yale University

Investigators

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

More Information

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT00660192
• Other Study ID Numbers: 0709003056
• First Posted: April 17, 2008
• Results First Posted: March 14, 2016
• Last Update Posted: March 14, 2016
• Last Verified: February 2016

Keywords provided by Yale University:

Migraine, refractory migraine, Pain, Botulinum Toxin , Botox

Additional relevant MeSH terms:

Migraine Disorders; Headache; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations