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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Migraine Headache
• Intervention / Treatment: Device: Automated Variable Pressure Insufflation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85254
      • Regen Pain and Wellness
  • Florida
    • Saint Petersburg, Florida, United States, 33701
      • Murray Chiropractic Neurology
  • Missouri
    • Saint Charles, Missouri, United States, 63303
      • StudyMetrix

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Prior or current diagnosis of migraine with brainstem aura, hemiplegic migraine, retinal migraine, migraine aura without headache, vestibular migraine.
2. Use of acute headache medication within previous 48 hours of treatment visit (for each treatment visit).
3. Use of acute medication for headache on >15 days per month in the 3 months prior to the Baseline Visit.
4. Change in migraine preventive therapies or dosage within the preceding 1 month of Baseline Visit.
5. Use of an opioid or barbiturate on more than 4 days per month in each of the 3 months prior to the Baseline Visit.
6. Other primary headache disorder, other than tension-type headache on 3 or fewer days per month.
7. History of secondary non-migraine headache disorders.
8. 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.
9. Discomfort, infection, or other abnormal symptoms or disorders of either ear within 1 month prior to the enrollment Screening or Treatment Visit.
10. Pregnant or trying to become pregnant.
11. Unable to provide informed consent.
12. Inability to present to the medical clinic for study treatment during a migraine attack.
13. Unable or unlikely to follow instructions for proper use of the device.
14. 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).
15. History of receiving ear pressure therapy (insufflation) to treat any condition.
16. Personal or family affiliation as a service provider (e.g. employee, contractor, consultant, or volunteer) with a migraine treatment device company other than the study sponsor.
17. Perforated or compromised tympanic membrane, and which is confirmed by otoscope inspection by the Investigator before or upon presentation of the subject for the Treatment Visit.
18. Any other information about the subject's medical condition that, in the reasonable professional judgement of the Investigator, may adversely affect the intended safety or results of the treatment as intended and as a reasonable basis to exclude the subject.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham treatment; 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; Acute migraine treatment
Experimental: Active Treatment; 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; Acute migraine treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Freedom Rates - active	Pain freedom rates (PFR)	2 Hours post treatment

Collaborators and Investigators

• Sponsor: Nocira, LLC
• Investigators: Study Director: David George, Nocira, LLC

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2020
• Primary Completion (Actual): June 30, 2022
• Study Completion (Anticipated): October 31, 2022

Study Registration Dates

• First Submitted: October 6, 2020
• First Submitted That Met QC Criteria: October 6, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): September 10, 2022
• Last Update Submitted That Met QC Criteria: September 8, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache
• Other Study ID Numbers: NC05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No