NCT04584762

Automated Variable Pattern Insufflator Device (AVPI) for the Acute Treatment of Migraine

Automated Variable Pattern Insufflator Device (AVPI) for the Acute Treatment of Migraine: a Prospective, Randomized, Double-blind, Parallel Group, Sham-controlled Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Nocira, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Randomized, sham-controlled, double-blind study for acute migraine attacks. Randomized to active treatment and sham treatment arms for the first treatment. Optional second active treatment. Follow up at 0, 2 and 24 hours post-treatment.

Detailed description

Randomized, sham-controlled, double-blind study for acute migraine attacks. Treatment Phase: • ≤60 days to present at clinic for treating up to 2 migraines (at least 48 hours apart). First treatment is randomized between active treatment and sham treatment. Second optional treatment is open-label. Post-Treatment Follow-up Phase: * 24 hours after initiating treatment, for each of up to two migraine treatments, for conducting post-treatment follow-up assessments of migraine symptoms. * 30, 60, and 90 days following the first migraine treatment for migraine diary assessments (and MIDAS assessment at 90 days) Collection of migraine diaries at 30, 60, \& 90 days post enrollment. Collection of MIDAS data at 60 and 90 days post treatment.

Conditions

• Migraine Headache

Interventions

Type	Name	Description
DEVICE	Automated Variable Pressure Insufflation	Acute migraine treatment

Timeline

• Start date: 2020-03-09
• Primary completion: 2022-06-30
• Completion: 2022-10-31
• First posted: 2020-10-14
• Last updated: 2022-09-10

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study