MigraineNC06NCT05537818
AVPI Migraine Study
A study testing AVPI Device in people with Migraine, run by Nocira, LLC at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Migraine
- What is being tested?
- AVPI Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Jun 2022to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 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
Who cannot join
- Failure to meet any of the inclusion criteria.
- 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.
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- 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.
- Any other information about the subject's medical condition that, in the reasonable professional judgement of the Investigator, may adversely affect the intended performance or safety of the study device, or that would confound understanding of the subjects' response to treatment with the device.
- Subjects who have been diagnosed with and/or being treated for currently active chronic neck pain conditions including, but not limited to, failed neck surgery, discogenic pain, radiculopathy, or whiplash.
- Psychiatric or cognitive disorders that in the investigator's opinion would interfere with the conduct of the study
- Unstable medical conditions which in the investigator's opinion could impede or preclude successful participation in the study, cause significant risk of serious adverse events in the study, or limit the subject's ability to complete study related treatments or assessments.
- MEDICATIONS \& MIGRAINE TREATMENTS
- Change in migraine preventive therapies or dosage within the preceding 3 months of Baseline Visit OR at any point during the study.
- Head or neck nerve block injections in the past 2 months.
- Post-COVID-19 patients with new presentations of dysautonomia, cognitive sensory changes, and imbalance presenting complaints which would limit the subject's ability to accurately and reliably identify and assess migraine pain, in the investigator's opinion.
- Previous use of pressure therapy or surgery in the ear for headache or any other condition (excluding diagnostic ear insufflation). Subjects enrolling in Group Ib will have participated in the NC05 study and will be allowed to enter as an exception to this criterion.
- Subjects treated with acute migraine medication via IV infusion within two weeks prior to screening.
- Subjects with previous absence of therapeutic response to 3 or more acute migraine neuromodulation devices. (Does not include failure of therapy due to side effects or intolerance.)
- Subjects with previous absence of therapeutic response to 3 or more classes of prescription migraine-specific abortive therapies as judged by the investigator. (Does not include failure of therapy due to side effects, drug interactions, or intolerance.)
- Use of an opioid or barbiturate on more than 4 days per month on average for the 3 months prior to the Baseline Visit.
- Individual migraine attacks are excluded from treatment and/or analysis in this study if:
- Treated >45 days after enrollment into active participation in each study Phase, applicable for all Groups. Subjects entering into active participation for Phase I and/or II will have 45 days to treat migraines for that respective Phase. For Phase II, the 45 days begins after the subject is trained and sent home with an AVPI device system.
- Migraine treated more than 10 hours (for Phase I) or 6 hours (for Phase II) after initial onset of the migraine. Migraines for which the subject cannot reasonably identify the initial onset.
- The migraine onset is <24 hours after the complete resolution of a prior migraine attack.
- The migraine attack was previously treated with any drug or medical device.
- The attack is characterized by neck pain that the subject indicates is greater than or equal to the severity of the headache pain.
- The subject has developed an ear infection or other new disorder of either ear since enrollment in the study.
- The subject has used acute headache or migraine medication or a neuromodulation device for migraine within previous 24 hours of treatment (for each treatment).
- The migraine headache intended for treatment during a randomized arm of either Phase is not at least moderate to severe. Note: Treatment of mild headaches are allowed during the open-label use arm of either Phase II.
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
StudyMetrix
Saint Charles, Missouri, 63303
Mitzi Sutton, 636-387-5100
Tim Smith, MD, 6363875100, tsmith@studymetrix.com
- Recruiting
ReGen Pain & Wellness
Scottsdale, Arizona, 85260-1911
Keith Smigiel, FNP-C DC, 480-341-5174, drkeith@msn.com
Keith Smigiel, FNP-C DC
- Not yet recruiting
ClinVest
Springfield, Missouri, 65807
David True, DO
About this study
Official title: Automated Variable Pattern Insufflator Device (AVPI) for the Acute Treatment of Migraine: a Multicenter, Double-blind, Randomized, Sham-controlled Trial
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.
Read the detailed description
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.
The timing of enrollments into each group will vary between sequentially timed Phases I \& II. Group 1 subjects may participate in both Phases. Group 2 subjects participate only in Phase II.
Group 1 subjects may participate for up to 90 days (45 days for each of Phases I\&II). Group 2 subjects will participate for up to 45 days.
- Conditions
- Migraine
- Being tested
- AVPI Device
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVPI DeviceDevice
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.
- AVPI device for pressure regulation
- Earpiece Assembly - a small, flexible, hollow tube that divides into right and left earpieces
- Earbuds - replaceable, multiple sizes
- Smartphone with the AVPI app
| Study group | Role | What they receive |
|---|---|---|
| Group 1a Clinic Treatment | Experimental | Randomized, active or sham in-clinic treatment during a migraine, followed by open-label treatments in the home environment. Receives: Device: AVPI Device |
| Group 1b Clinic & Home Treatment | Other | Open-label, active treatment for subjects treated in prior clinical trials for this device, followed by open-label treatments in the home environment. Receives: Device: AVPI Device |
| Group 2 Home Treatment | Experimental | Randomized active or sham for first home treatment followed by open-label treatments in the home environment. Receives: Device: AVPI Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache Pain Freedom
- Proportion of subjects who are free from headache pain at two hours post treatment without using rescue medication.
Measured: 2 hours post initiation of treatment
Secondary outcomes (12)
Freedom from the most bothersome symptom (MBS)
Proportion of subjects who have freedom from their most bothersome symptom (MBS) at two hours after initiation of treatment.
Measured: 2 hours post initiation of treatment
Significant relief from headache pain
Proportion of subjects who have significant relief from headache pain 2 hours after initiation of treatment.
Measured: 2 hours post initiation of treatment
Pain freedom at end of treatment
Proportion of subjects who are free from headache pain at the end of treatment.
Measured: Immediately post treatment of 20-40 minutes
Significant headache relief at the end of treatment
Proportion of subjects who have significant headache pain relief at the end of treatment.
Measured: Immediately post treatment of 20-40 minutes
Sustained pain freedom
Proportion of subjects with sustained freedom from headache pain from 2 hours to 24 hours after initiation of treatment.
Measured: 24 hours post initiation of treatment
Significant relief of most bothersome symptom
Proportion of subjects who have significant relief from their most bothersome symptom (MBS) 2 hours after initiation of treatment.
Measured: 2 hours post initiation of treatment
Use of rescue meds prior to 24 hours post treatment
Proportion of subjects who use rescue medications prior to 24 hours post treatment
Measured: 24 hours post treatment
Overall satisfaction
Overall satisfaction at post-treatment phase using a modified version of the Revised Patient Perception of Migraine Questionnaire (PPMQ-R)
Measured: Post treatment phase (45 days)
Functional compromise freedom
Proportion of subjects who are free of migraine related functional compromise 2 hours after initiation of treatment.
Measured: 2 hours post initiation of treatment
Proportion active treatments achieving pain freedom
Proportion of all active treatments that achieved pain freedom by end of treatment or at 2 hours from starting treatment.
Measured: End of treatment or at 2 hours post initiation of treatment
Proportion active treatments achieving pain freedom at end of treatment
Proportion of all active treatments that achieved significant pain relief by end of treatment or at 2 hours from starting treatment
Measured: Immediately post treatment of 20-40 minutes
Proportion of first randomized active vs first open-label achieving pain freedom
Proportion of first randomized active treatments vs. first open label active treatments that achieve headache pain freedom at 2 hours from starting treatment.
Measured: 2 hours post initiation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start30 Jun 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-center, double-blind, randomized, sham-controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nocira, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05537818
- Sponsor's protocol ID
- NC06
- Acronym
- NC06
- Status last verified
- Nov 2022
- First submitted
- 25 May 2022
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Variable Pattern Insufflator Device (AVPI) for the Acute Treatment of Migraine: a Multicenter, Double-blind, Randomized, Sham-controlled Trial
- ClinicalTrials.gov ID
- NCT05537818
- Acronym / sponsor ID
- NC06 / NC06
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Nocira, LLCIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 13 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
The timing of enrollments into each group will vary between sequentially timed Phases I \& II. Group 1 subjects may participate in both Phases. Group 2 subjects participate only in Phase II.
Group 1 subjects may participate for up to 90 days (45 days for each of Phases I\&II). Group 2 subjects will participate for up to 45 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Multi-center, double-blind, randomized, sham-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Group 1a Clinic Treatment | Experimental | Device: AVPI DeviceRandomized, active or sham in-clinic treatment during a migraine, followed by open-label treatments in the home environment. |
| Group 1b Clinic & Home Treatment | Other | Device: AVPI DeviceOpen-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 | Experimental | Device: AVPI DeviceRandomized active or sham for first home treatment followed by open-label treatments in the home environment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18-75 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.
Key exclusion criteria (38 listed)
- Failure to meet any of the inclusion criteria.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVPI DeviceThe 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 | Device | Group 1a Clinic Treatment, Group 1b Clinic & Home Treatment, Group 2 Home Treatment |
Primary outcome
Headache Pain Freedom
Time frame: 2 hours post initiation of treatment
1. Proportion of subjects who are free from headache pain at two hours post treatment without using rescue medication.
12 secondary outcomes
Freedom from the most bothersome symptom (MBS)
Time frame: 2 hours post initiation of treatment
Significant relief from headache pain
Time frame: 2 hours post initiation of treatment
Pain freedom at end of treatment
Time frame: Immediately post treatment of 20-40 minutes
Significant headache relief at the end of treatment
Time frame: Immediately post treatment of 20-40 minutes
Sustained pain freedom
Time frame: 24 hours post initiation of treatment
Significant relief of most bothersome symptom
Time frame: 2 hours post initiation of treatment
Use of rescue meds prior to 24 hours post treatment
Time frame: 24 hours post treatment
Overall satisfaction
Time frame: Post treatment phase (45 days)
Functional compromise freedom
Time frame: 2 hours post initiation of treatment
Proportion active treatments achieving pain freedom
Time frame: End of treatment or at 2 hours post initiation of treatment
Proportion active treatments achieving pain freedom at end of treatment
Time frame: Immediately post treatment of 20-40 minutes
Proportion of first randomized active vs first open-label achieving pain freedom
Time frame: 2 hours post initiation of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AVPI Device in people with Migraine, run by Nocira, LLC at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David George (4803021215, david@nocira.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache Pain Freedom (time frame: 2 hours post initiation of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.