Transnasal Sphenopalatine Ganglia Block for Management of Chronic Migraines in Pediatric Patients
Primary Purpose
Migraine in Children, Pain, Neuropathic
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Headache Journal
Sphenopalatine Block
Tx360
Sponsored by
About this trial
This is an interventional treatment trial for Migraine in Children
Eligibility Criteria
Inclusion Criteria:
Children ages 8 to 17 years old Meet the criteria for chronic migraines Have remained stable on their current headache medication for a minimum of 4 weeks.
Able to provide informed consent from parent or legal guardian Able to provide assent if subject is a minor of appropriate age
Exclusion Criteria:
Allergy to local anesthetic Developmental delay (e.g. non-verbal) Inability to use numeric pain scale Inability to perform or tolerate transnasal procedure Substance abuse disorders Known pregnancy
Sites / Locations
- St. Louis Children's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Minors with chronic migraines
Arm Description
Outcomes
Primary Outcome Measures
Reduction in frequency of headache days: pre-treatment
Weekly headache journal check in - 5 questions with y/n answers and free text entry
Reduction in frequency of headache days: post-treatment
Weekly headache journal check in - 5 questions with y/n answers and free text entry
Secondary Outcome Measures
Maximum headache severity: pre-treatment
Participant records headache intensity on headache journal. Scale is 0-10, with 0 being the least severity and 10 being the worst severity
Maximum headache severity: post-treatment
Participant records headache intensity on headache journal. Scale is 0-10, with 0 being the least severity and 10 being the worst severity
Headache duration: pre-treatment
Participant records headache duration by documenting the start and end time of the headache
Headache duration: post-treatment
Participant records headache duration by documenting the start and end time of the headache
Use of rescue medication: pre-treatment
Participant records use with a y/n answer and provides the name of the medication
Use of rescue medication: post-treatment
Participant records use with a y/n answer and provides the name of the medication
Full Information
NCT ID
NCT04466826
First Posted
July 6, 2020
Last Updated
February 5, 2021
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04466826
Brief Title
Transnasal Sphenopalatine Ganglia Block for Management of Chronic Migraines in Pediatric Patients
Official Title
Transnasal Sphenopalatine Ganglia Block for Management of Chronic Migraines in Pediatric Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Low enrollment
Study Start Date
January 2, 2021 (Actual)
Primary Completion Date
February 5, 2021 (Actual)
Study Completion Date
February 5, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Single-center, open-label, pre-post treatment pilot study to evaluate the safety and effectiveness of sphenopalatine ganglia blocks for the treatment of chronic migraine in the pediatric population. 50 children with a diagnosis of chronic migraines will undergo a series of three transnasal sphenopalatine ganglia blocks to measure their effect on headache frequency, headache intensity, headache duration, and use of headache medication.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine in Children, Pain, Neuropathic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Model Description
Open label, pre/post-treatment pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Minors with chronic migraines
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Headache Journal
Intervention Description
Phase 1 of study to determine a baseline for headache frequency, headache intensity and medication usage patterns
Intervention Type
Drug
Intervention Name(s)
Sphenopalatine Block
Intervention Description
Phase 2 of study providing medication using 0.3ml of 0.5% Bupivacaine per nares delivered intranasal via the Tx360 device
Intervention Type
Device
Intervention Name(s)
Tx360
Intervention Description
Phase 2 of study providing medication using 0.3ml of 0.5% Bupivacaine per nares delivered intranasal via the Tx360 device
Primary Outcome Measure Information:
Title
Reduction in frequency of headache days: pre-treatment
Description
Weekly headache journal check in - 5 questions with y/n answers and free text entry
Time Frame
Up to 4 weeks following consent
Title
Reduction in frequency of headache days: post-treatment
Description
Weekly headache journal check in - 5 questions with y/n answers and free text entry
Time Frame
Up to one year following consent
Secondary Outcome Measure Information:
Title
Maximum headache severity: pre-treatment
Description
Participant records headache intensity on headache journal. Scale is 0-10, with 0 being the least severity and 10 being the worst severity
Time Frame
up to 4 weeks following consent
Title
Maximum headache severity: post-treatment
Description
Participant records headache intensity on headache journal. Scale is 0-10, with 0 being the least severity and 10 being the worst severity
Time Frame
up to one year following consent
Title
Headache duration: pre-treatment
Description
Participant records headache duration by documenting the start and end time of the headache
Time Frame
Up to 4 weeks following consent
Title
Headache duration: post-treatment
Description
Participant records headache duration by documenting the start and end time of the headache
Time Frame
Up to one year following consent
Title
Use of rescue medication: pre-treatment
Description
Participant records use with a y/n answer and provides the name of the medication
Time Frame
Up to 4 weeks following consent
Title
Use of rescue medication: post-treatment
Description
Participant records use with a y/n answer and provides the name of the medication
Time Frame
Up to one year following consent
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children ages 8 to 17 years old Meet the criteria for chronic migraines Have remained stable on their current headache medication for a minimum of 4 weeks.
Able to provide informed consent from parent or legal guardian Able to provide assent if subject is a minor of appropriate age
Exclusion Criteria:
Allergy to local anesthetic Developmental delay (e.g. non-verbal) Inability to use numeric pain scale Inability to perform or tolerate transnasal procedure Substance abuse disorders Known pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob AuBuchon, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20875042
Citation
Abu-Arafeh I, Razak S, Sivaraman B, Graham C. Prevalence of headache and migraine in children and adolescents: a systematic review of population-based studies. Dev Med Child Neurol. 2010 Dec;52(12):1088-97. doi: 10.1111/j.1469-8749.2010.03793.x. Epub 2010 Sep 28.
Results Reference
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PubMed Identifier
23245607
Citation
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Wober-Bingol C. Epidemiology of migraine and headache in children and adolescents. Curr Pain Headache Rep. 2013 Jun;17(6):341. doi: 10.1007/s11916-013-0341-z.
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Transnasal Sphenopalatine Ganglia Block for Management of Chronic Migraines in Pediatric Patients
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