(Botox) Mechanisms of Action in Altering the Molecular Environment in Which Pain Fibers Exist



Status:Recruiting
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 65
Updated:3/21/2019
Start Date:December 1, 2017
End Date:August 2020
Contact:William G Austen
Email:wausten@partners.org
Phone:6174599106

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Novel Concepts for OnabotulinumtoxinA (Botox) Mechanisms of Action: Role in Altering the Molecular Environment in Which Pain Fibers Exist

To compare Botox-treated and Botox-untreated symptomatic tissues (defined as areas where the
head hurts and the pain is felt) of chronic migraine (CM) patients using molecular studies.

Eligible patients for migraine surgery will be injected unilaterally with Botox prior to
surgery. The effects of Botox on tissues will be evaluated.

Inclusion Criteria:

- Age 18-65 years

- Diagnosis of Chronic Migraine consistent with International Classification of Headache
Disorders (ICHD-III) criteria, with a history of bilateral headache pain and chronic
tenderness in neck muscles

- Patient is capable and willing to provide informed consent

- Female subjects of child bearing potential must have a negative pregnancy test at
enrollment and agree to remain abstinent or use acceptable methods of birth control
(i.e., hormonal contraceptives, inrauterine device, diaphragm with spermicide,
cervical cap or sponge, condoms or partner has had a vasectomy) for three months
following injections of Botox

- Patients referred by their primary Neurologist to the study surgeon and who are
determined to be candidates for surgical decompression of extracranial sensory nerves.

- Patient agrees to abstain from protocol-specific excluded medications beginning 14
days prior to the decompression surgery.

Exclusion Criteria:

- Patient has hypersensitivity reactions or other intolerance to Botox

- Patient is pregnant or trying to become pregnant with the timeframe of the study.

- Infection at proposed injection sites.
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-459-9106
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Boston, MA
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