Migraine HeadacheNCT04584762
Automated Variable Pattern Insufflator Device (AVPI) for the Acute Treatment of Migraine
A study testing Automated Variable Pressure Insufflation in people with Migraine Headache, run by Nocira, LLC at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine Headache
- What is being tested?
- Automated Variable Pressure Insufflation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 3 sitesUnited States
- Study dates
- 9 Mar 2020to 31 Oct 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- 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.
- 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.
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
StudyMetrix
Saint Charles, Missouri, 63303
Regen Pain and Wellness
Scottsdale, Arizona, 85254
Murray Chiropractic Neurology
St. Petersburg, Florida, 33701
About this study
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
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.
Read the 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.
- Conditions
- Migraine Headache
- Being tested
- Automated Variable Pressure Insufflation
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated Variable Pressure InsufflationDevice
Acute migraine treatment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Automated Variable Pressure Insufflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Freedom Rates - active
Pain freedom rates (PFR)
Measured: 2 Hours post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start9 Mar 2020
- Primary completion30 Jun 2022
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine HeadacheStudies 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
- Prospective, randomized, double-blind, parallel group, sham-controlled
- 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
- Investigators
- David George, Study director, Nocira, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584762
- Sponsor's protocol ID
- NC05
- Status last verified
- Sep 2022
- First submitted
- 6 Oct 2020
- Last updated
- 10 Sep 2022
- 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 Sep 2022. 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 Prospective, Randomized, Double-blind, Parallel Group, Sham-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04584762
- Acronym / sponsor ID
- NC05
- Conditions
- Migraine Headache
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Nocira, LLCIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 14 Oct 2020 (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.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Prospective, randomized, double-blind, parallel group, sham-controlled
| Arm | Type | Receives |
|---|---|---|
| Sham treatment | Sham comparator | Device: Automated Variable Pressure InsufflationThe 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. |
| Active Treatment | Experimental | Device: Automated Variable Pressure InsufflationThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
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 |
|---|---|---|
| Automated Variable Pressure InsufflationAcute migraine treatment | Device | Active Treatment, Sham treatment |
Primary outcome
Pain Freedom Rates - active
Time frame: 2 Hours post treatment
Pain freedom rates (PFR)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2022.
- 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.
David George study director
Nocira, LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated Variable Pressure Insufflation in people with Migraine Headache, 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 7 inclusion and 18 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 Sep 2022. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Freedom Rates - active (time frame: 2 Hours post 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 Sep 2022.