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

Yale University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Refractory Migraine

Treatments: Drug: Botox; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00660192

0709003056

Details and patient eligibility

About

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%.

Full description

Contact PI for study details

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo

Botox

Active Comparator group

Description:

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.

Treatment:

Drug: Botox