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

NCT04584762 | Unknown FDA Device

• 1 other identifier: NC05
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (1)

• Pain Freedom Rates - active

  Pain freedom rates (PFR)

  2 Hours post treatment

Study Arms (2)

Sham treatment

SHAM COMPARATOR

The AVPI device software is set in "sham mode" which does not deliver the therapy to the subject. Neither the subject or the investigator is aware of which mode is being used.

Device: Automated Variable Pressure Insufflation

Active Treatment

EXPERIMENTAL

The AVPI device software is set in "active mode" which delivers the therapy to the subject. Neither the subject or the investigator is aware of which mode is being used.

Device: Automated Variable Pressure Insufflation

Interventions

Automated Variable Pressure Insufflation DEVICE

Acute migraine treatment

Active Treatment; Sham treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age at the time of the baseline visit.
• Episodic migraine with or without aura diagnosed according to the International Classification of Headache Disorders 3 beta diagnostic criteria.
• Migraine onset before the age of 50 years
• Migraine present for at least 1 year at the time of the Baseline Visit.
• Frequency of 1-12 migraine attacks per month in each of the 2 months prior to screening.
• Willingness, ability, and commitment to participate in baseline and follow-up evaluations without concurrent participation in another clinical trial.
• Signed patient informed consent form.

You may not qualify if:

• Prior or current diagnosis of migraine with brainstem aura, hemiplegic migraine, retinal migraine, migraine aura without headache, vestibular migraine.
• Use of acute headache medication within previous 48 hours of treatment visit (for each treatment visit).
• Use of acute medication for headache on \>15 days per month in the 3 months prior to the Baseline Visit.
• Change in migraine preventive therapies or dosage within the preceding 1 month of Baseline Visit.
• Use of an opioid or barbiturate on more than 4 days per month in each of the 3 months prior to the Baseline Visit.
• Other primary headache disorder, other than tension-type headache on 3 or fewer days per month.
• History of secondary non-migraine headache disorders.
• Medical history of Meniere's disease; endolymphatic hydrops; loss of hearing in either ear that is either complete, requires a hearing aid, or has deteriorated noticeably over the past year; ear surgery (including ear tubes); chronic continuous or current tinnitus; superior canal dehiscence.
• Discomfort, infection, or other abnormal symptoms or disorders of either ear within 1 month prior to the enrollment Screening or Treatment Visit.
• Pregnant or trying to become pregnant.
• Unable to provide informed consent.
• Inability to present to the medical clinic for study treatment during a migraine attack.
• Unable or unlikely to follow instructions for proper use of the device.
• Presence of any condition or state that would prevent the subject from sitting or lying down during the course of the treatment (up to 30 minutes).
• History of receiving ear pressure therapy (insufflation) to treat any condition.

Sponsors & Collaborators

• Nocira, LLC: lead

Study Sites (3)

Regen Pain and Wellness

Scottsdale, Arizona, 85254, United States

Location

Murray Chiropractic Neurology

St. Petersburg, Florida, 33701, United States

Location

StudyMetrix

Saint Charles, Missouri, 63303, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• David George

  Nocira, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, double-blind, parallel group, sham-controlled

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 14, 2020
• Study Start: March 9, 2020
• Primary Completion: June 30, 2022
• Study Completion: October 31, 2022
• Last Updated: September 10, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)