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

NCT04584762 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-09-10

No results posted yet for this study

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.

Conditions

  • Migraine Headache

Interventions

DEVICE

Automated Variable Pressure Insufflation

Acute migraine treatment

Sponsors & Collaborators

  • Nocira, LLC

    lead INDUSTRY

Principal Investigators

  • David George · Nocira, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-09
Primary Completion
2022-06-30
Completion
2022-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04584762 on ClinicalTrials.gov