AVPI Migraine Study
NC06
Automated Variable Pattern Insufflator Device (AVPI) for the Acute Treatment of Migraine: a Multicenter, Double-blind, Randomized, Sham-controlled Trial
1 other identifier
interventional
80
1 country
3
Brief Summary
The study is designed as a multicenter, double-blind, randomized, sham-controlled trial to assess the safety and effectiveness of the Nocira AVPI Device for the acute treatment of migraine. The study is conducted in two phases in two study groups:
- Phase I - initial screening of device operation in both active and sham modes in-clinic and as proctored by the investigator, and
- Phase II - for further evaluation when used in the home (non-clinical) environment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2022
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2022
CompletedStudy Start
First participant enrolled
June 30, 2022
CompletedFirst Posted
Study publicly available on registry
September 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2024
CompletedMay 10, 2023
November 1, 2022
1.5 years
May 25, 2022
May 8, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Headache Pain Freedom
1\. Proportion of subjects who are free from headache pain at two hours post treatment without using rescue medication.
2 hours post initiation of treatment
Secondary Outcomes (12)
Freedom from the most bothersome symptom (MBS)
2 hours post initiation of treatment
Significant relief from headache pain
2 hours post initiation of treatment
Pain freedom at end of treatment
Immediately post treatment of 20-40 minutes
Significant headache relief at the end of treatment
Immediately post treatment of 20-40 minutes
Sustained pain freedom
24 hours post initiation of treatment
- +7 more secondary outcomes
Study Arms (3)
Group 1a Clinic Treatment
EXPERIMENTALRandomized, active or sham in-clinic treatment during a migraine, followed by open-label treatments in the home environment.
Group 1b Clinic & Home Treatment
OTHEROpen-label, active treatment for subjects treated in prior clinical trials for this device, followed by open-label treatments in the home environment.
Group 2 Home Treatment
EXPERIMENTALRandomized active or sham for first home treatment followed by open-label treatments in the home environment.
Interventions
The AVPI device system consists of a small, hand-held, micro-pressure pulse generator device that is operated by a hand-held mobile smartphone (iPhone®) with a downloaded software application or "app." The AVPI device is connected to an earpiece assembly that splits into two earbuds (right and left) that seat comfortably into each respective ear. 1. AVPI device for pressure regulation 2. Earpiece Assembly - a small, flexible, hollow tube that divides into right and left earpieces 3. Earbuds - replaceable, multiple sizes 4. Smartphone with the AVPI app
Eligibility Criteria
You may qualify if:
- years of age, inclusive, with at least a one-year history of migraine consistent with the ICHD-3 criteria
- Migraine onset before the age of 50 years
- Migraine attack frequency of 2-10 attacks per month with no more than 20 headache days per month on average over the last 3 months
- Willingness, ability, and commitment to participate in baseline and follow-up evaluations without concurrent participation in another clinical trial.
- Signed subject informed consent form.
- Typical untreated migraines are historically at least moderate to severe, by patient report.
- Subjects on prophylactic migraine medication must have been on a stable dose for at least 3 months prior to study entry and must remain on the same therapy with stable dosing during the study.
- Subjects must have wireless access to the internet via mobile computing or smartphone device for audio and/or video contacts
You may not qualify if:
- Unwilling or unable to provide informed consent.
- Pregnancy or intent to become pregnant over the course of the study.
- Inability to distinguish migraine from other primary headache phenotypes.
- Presence of any condition or state that would prevent the subject from sitting or lying down comfortably during the course of the treatment (up to at least 30 minutes).
- Unable or unlikely to follow instructions for proper use of the device including connection of the phone to a wireless connection.
- Personal or family affiliation as a service provider - e.g., employee, contractor, consultant, or volunteer (other than as a subject in a previous clinical trial) - with a migraine treatment device company.
- Subjects with vital sign values that are outside acceptable norms.
- Systolic blood pressure \> 160 mmHg
- Diastolic blood pressure \> 100mmHg
- Resting heart rate \>100 beats per minute
- Temperature \> 100.5°F
- History of significant vestibular, auditory or external ear diagnoses or symptoms, including but not limited to Meniere's disease; endolymphatic hydrops; complete loss of hearing in either ear, significant hearing loss in either ear that requires a hearing aid or has deteriorated noticeably over the past year; previous ear surgery (including tympanostomy tubes); superior canal dehiscence, current or ongoing dizziness or vertigo, perforated or compromised tympanic membrane, external auditory canal obstruction which cannot be removed prior to treatment
- Current diagnosis or significant prior diagnosis of secondary headache (except MOH headache), cerebral aneurysm, intracranial hemorrhage, brain tumor, chiari malformation, or currently active occipital neuralgia that in the investigator's opinion would interfere with study-related assessments.
- Recent or current diagnoses of post-concussion syndrome, significant head trauma, substance abuse, addiction, syncope, or epilepsy, that in that the investigator's opinion would interfere in the assessments.
- Another significant pain disorder that in the investigator's opinion would interfere with study-related assessments.
- +22 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nocira, LLClead
Study Sites (3)
ReGen Pain & Wellness
Scottsdale, Arizona, 85260-1911, United States
StudyMetrix
Saint Charles, Missouri, 63303, United States
ClinVest
Springfield, Missouri, 65807, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Sham and active treatments
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2022
First Posted
September 13, 2022
Study Start
June 30, 2022
Primary Completion
December 31, 2023
Study Completion
January 31, 2024
Last Updated
May 10, 2023
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share