NCT04466826

Transnasal Sphenopalatine Ganglia Block for Management of Chronic Migraines in Pediatric Patients

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 8 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Migraine in Children
• Pain, Neuropathic

Interventions

Type	Name	Description
OTHER	Headache Journal	Phase 1 of study to determine a baseline for headache frequency, headache intensity and medication usage patterns
DRUG	Sphenopalatine Block	Phase 2 of study providing medication using 0.3ml of 0.5% Bupivacaine per nares delivered intranasal via the Tx360 device
DEVICE	Tx360	Phase 2 of study providing medication using 0.3ml of 0.5% Bupivacaine per nares delivered intranasal via the Tx360 device

Timeline

• Start date: 2021-01-02
• Primary completion: 2021-02-05
• Completion: 2021-02-05
• First posted: 2020-07-10
• Last updated: 2021-02-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study