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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03381261
Recruitment Status : Unknown
Verified March 2019 by William Gerald Austen, Massachusetts General Hospital.
Recruitment status was:  Recruiting
First Posted : December 21, 2017
Last Update Posted : March 19, 2019
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
William Gerald Austen, Massachusetts General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Migraine Drug: Botulinum toxin type A Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Novel Concepts for OnabotulinumtoxinA (Botox) Mechanisms of Action: Role in Altering the Molecular Environment in Which Pain Fibers Exist
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Botox Migraine

Arm Intervention/treatment
Experimental: Botulinum toxin type A injection arm
All patients will be injected with Botulinum toxin on one side of the back of the head.
Drug: Botulinum toxin type A
Injection of Botulinum toxin type A in back of head
Other Name: Botox

Primary Outcome Measures :
  1. molecular markers in discarded tissue of migraine patients [ Time Frame: one year ]
    molecular markers in discarded tissue of migraine surgery will be analyzed. Gene Expression CodeSet profiling 594 genes; 579 immunology-related human genes + 15 internal reference controls.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03381261

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Contact: William G Austen 6174599106
Contact: Lisa Gfrerer 6174599106

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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: William G. Austen, MD    617-459-9106   
Contact: Lisa Gfrerer, MD PhD    6174599106   
Sponsors and Collaborators
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
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Principal Investigator: William G. Austen, MD Massachusetts General Hospital
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Responsible Party: William Gerald Austen, Chief, Plastic and Reconstructive Surgery; Chief, Burn Surgery, Massachusetts General Hospital Identifier: NCT03381261    
Other Study ID Numbers: 2017P001813
First Posted: December 21, 2017    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by William Gerald Austen, Massachusetts General Hospital:
chronic migraine
trigeminal neuralgia
migraine surgery
nerve decompression
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents