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

NCT ID: NCT00660192

Last Updated: 2016-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2015-07-31

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

Conditions

Refractory Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

Botox

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Other Intervention Names

onobotulinumtoxinA; Saline

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bahman Jabbari, M.D.

Role: PRINCIPAL_INVESTIGATOR

Yale- 203-737-2464

Locations

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

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

0709003056

Identifier Type: -

Identifier Source: org_study_id