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Sphenopalatine Ganglion Blocks RCT (SPGblock)

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ClinicalTrials.gov Identifier: NCT03666663
Recruitment Status : Recruiting
First Posted : September 12, 2018
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
Nina Riggins, MD, University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE September 8, 2018
First Posted Date  ICMJE September 12, 2018
Last Update Posted Date March 26, 2020
Actual Study Start Date  ICMJE February 1, 2019
Estimated Primary Completion Date October 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2018)
Reduction in headache days [ Time Frame: 8 months ]
Reduction in headache days from baseline to month 8 of treatment
Original Primary Outcome Measures  ICMJE
 (submitted: September 8, 2018)
Reduction in headache days [ Time Frame: 16 weeks ]
Reduction in headache days from baseline to month 3 of treatment
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 Sphenopalatine Ganglion Blocks RCT
Official Title  ICMJE UCSF Sphenopalatine Ganglion Block Study- a Randomized Double Blind Placebo Controlled Trial to Compare Nasal Anesthetics for Migraine Prevention in Adults.
Brief Summary RCT of Sphenopalatine Ganglion (SPG) Blocks using anesthetics vs. placebo for migraine.
Detailed Description

Chronic Migraine is a brain disorder with high prevalence. It is the 7th leading cause of disability worldwide according the WHO.

SPG block is a treatment for migraine that has been used for two decades. It can be done by needle injection of anesthetic to the region of the SPG. However, there are now multiple catheter devices that can be used to non-invasively administer anesthetic topically through the nasal cavity to the region of the SPG where the anesthetic is then absorbed through thin membranes covering the SPG.

Various anesthetic agents have been studied however currently, to our knowledge, there is no head to head comparison of the various anesthetics used. Studies of SPG blocks in the setting of chronic migraine are few as compared to the use of SPG as acute treatment for migraine.

With the use of an RCT, we aim to determine the overall efficacy of SPG blocks used at longer intervals than have been studied in the past as compared to placebo, as well as to examine the relative efficacy of the anesthetics used most commonly and studied for SPG blocks.

We will be using an FDA cleared device, the Sphenocath which was developed and registered with the FDA for this specific population and purpose. The study intervention is the standard practice in the UCSF Headache Center to perform SPG blocks for our patients with chronic migraine. The frequency we use in clinical practice and that we plan to study is less often than in previous studies of this intervention in this population.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized placebo controlled study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double blind study
Primary Purpose: Treatment
Condition  ICMJE Migraine
Intervention  ICMJE
  • Drug: Lidocaine
    Nasal application using the Sphenocath device- cleared by FDA
  • Drug: Bupivacaine
    Nasal application using the Sphenocath device- cleared by FDA
  • Drug: Ropivacaine
    Nasal application using the Sphenocath device- cleared by FDA
  • Drug: Placebo
    Placebo Saline using the Sphenocath device- cleared by FDA
    Other Name: Placebo Saline
Study Arms  ICMJE
  • Experimental: Lidocaine
    Participants will receive SPG blocks with lidocaine.
    Intervention: Drug: Lidocaine
  • Experimental: Bupivacaine
    Participants will receive SPG blocks with bupivacaine
    Intervention: Drug: Bupivacaine
  • Experimental: Ropivacaine
    Participants will receive SPG blocks with ropivacaine
    Intervention: Drug: Ropivacaine
  • Placebo Comparator: Placebo (saline)
    Participants will receive SPG blocks with placebo (saline)
    Intervention: Drug: Placebo
Publications *

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 30, 2018)
120
Original Estimated Enrollment  ICMJE
 (submitted: September 8, 2018)
100
Estimated Study Completion Date  ICMJE October 1, 2023
Estimated Primary Completion Date October 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age 18 years or more at time of consent
  2. Current patients in the UCSF Headache Center eligible to receive SPG blocks for migraine and would otherwise receive treatment clinically
  3. Ability to provide consent for the research study

Exclusion Criteria

  1. Pregnant or breast feeding within 4 weeks of enrollment
  2. Inability to communicate with the study team
  3. Patients who cannot read and understand English
  4. Deemed unsuitable for enrollment in study by the investigator
  5. Allergy to local anesthetics or saline
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nina Riggins, MD 415-353-8393 nina.riggins@ucsf.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03666663
Other Study ID Numbers  ICMJE 18-25736_SPG_2018.09
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.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nina Riggins, MD, University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nina Riggins, MD UCSF Headache Center
PRS Account University of California, San Francisco
Verification Date March 2020

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