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

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ClinicalTrials.gov Identifier: NCT04584762
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Nocira, LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Migraine Headache Device: Automated Variable Pressure Insufflation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized, double-blind, parallel group, sham-controlled
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Automated Variable Pattern Insufflator Device (AVPI) for the Acute Treatment of Migraine: a Prospective, Randomized, Double-blind, Parallel Group, Sham-controlled Clinical Trial
Actual Study Start Date : March 9, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Pain Freedom Rates - active [ Time Frame: 2 Hours post treatment ]
    Pain freedom rates (PFR)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04584762


Contacts
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Contact: Melissa Walker, MS RAC FRAPS 6364057498 mwalker@nocira.com

Locations
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United States, Arizona
Regen Pain and Wellness Recruiting
Scottsdale, Arizona, United States, 85254
Contact: Keith Smigiel, FNP, RN, DC    602-485-9390    drkeith@msn.com   
United States, Florida
Murray Chiropractic Neurology Recruiting
Saint Petersburg, Florida, United States, 33701
Contact: Anthony Murray, DC DACNB    727-254-8782    chiromurray@gmail.com   
Sub-Investigator: Kim Jesso, DC         
Sponsors and Collaborators
Nocira, LLC
Investigators
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Study Director: David George Nocira, LLC
More Information
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Responsible Party: Nocira, LLC
ClinicalTrials.gov Identifier: NCT04584762    
Other Study ID Numbers: NC05
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations