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

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
William Gerald Austen, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE December 18, 2017
First Posted Date  ICMJE December 21, 2017
Last Update Posted Date March 19, 2019
Actual Study Start Date  ICMJE December 1, 2017
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 20, 2017)
molecular markers in discarded tissue of migraine patients [ Time Frame: one year ]
molecular markers in discarded tissue of migraine surgery will be analyzed
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE (Botox) Mechanisms of Action in Altering the Molecular Environment in Which Pain Fibers Exist
Official Title  ICMJE Novel Concepts for OnabotulinumtoxinA (Botox) Mechanisms of Action: Role in Altering the Molecular Environment in Which Pain Fibers Exist
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Migraine
Intervention  ICMJE Drug: Botulinum toxin type A
Injection of Botulinum toxin type A in back of head
Other Name: Botox
Study Arms  ICMJE Experimental: Botulinum toxin type A injection arm
All patients will be injected with Botulinum toxin on one side of the back of the head.
Intervention: Drug: Botulinum toxin type A
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 20, 2017)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03381261
Other Study ID Numbers  ICMJE 2017P001813
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party William Gerald Austen, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Beth Israel Deaconess Medical Center
Investigators  ICMJE
Principal Investigator: William G. Austen, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP