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AVPI Migraine Study (NC06)

Primary Purpose

Migraine

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AVPI Device
Sponsored by
Nocira, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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. 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.

Sites / Locations

  • ReGen Pain & WellnessRecruiting
  • StudyMetrixRecruiting
  • ClinVest

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Experimental

Arm Label

Group 1a Clinic Treatment

Group 1b Clinic & Home Treatment

Group 2 Home Treatment

Arm Description

Randomized, active or sham in-clinic treatment during a migraine, followed by open-label treatments in the home environment.

Open-label, active treatment for subjects treated in prior clinical trials for this device, followed by open-label treatments in the home environment.

Randomized active or sham for first home treatment followed by open-label treatments in the home environment.

Outcomes

Primary Outcome Measures

Headache Pain Freedom
1. Proportion of subjects who are free from headache pain at two hours post treatment without using rescue medication.

Secondary Outcome Measures

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.
Significant relief from headache pain
Proportion of subjects who have significant relief from headache pain 2 hours after initiation of treatment.
Pain freedom at end of treatment
Proportion of subjects who are free from headache pain at the end of treatment.
Significant headache relief at the end of treatment
Proportion of subjects who have significant headache pain relief at the end of treatment.
Sustained pain freedom
Proportion of subjects with sustained freedom from headache pain from 2 hours to 24 hours after 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.
Use of rescue meds prior to 24 hours post treatment
Proportion of subjects who use rescue medications prior to 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)
Functional compromise freedom
Proportion of subjects who are free of migraine related functional compromise 2 hours after 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.
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
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.

Full Information

First Posted
May 25, 2022
Last Updated
May 8, 2023
Sponsor
Nocira, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05537818
Brief Title
AVPI Migraine Study
Acronym
NC06
Official Title
Automated Variable Pattern Insufflator Device (AVPI) for the Acute Treatment of Migraine: a Multicenter, Double-blind, Randomized, Sham-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nocira, LLC

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multi-center, double-blind, randomized, sham-controlled trial
Masking
ParticipantCare ProviderInvestigator
Masking Description
Sham and active treatments
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1a Clinic Treatment
Arm Type
Experimental
Arm Description
Randomized, active or sham in-clinic treatment during a migraine, followed by open-label treatments in the home environment.
Arm Title
Group 1b Clinic & Home Treatment
Arm Type
Other
Arm Description
Open-label, active treatment for subjects treated in prior clinical trials for this device, followed by open-label treatments in the home environment.
Arm Title
Group 2 Home Treatment
Arm Type
Experimental
Arm Description
Randomized active or sham for first home treatment followed by open-label treatments in the home environment.
Intervention Type
Device
Intervention Name(s)
AVPI Device
Intervention Description
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
Primary Outcome Measure Information:
Title
Headache Pain Freedom
Description
1. Proportion of subjects who are free from headache pain at two hours post treatment without using rescue medication.
Time Frame
2 hours post initiation of treatment
Secondary Outcome Measure Information:
Title
Freedom from the most bothersome symptom (MBS)
Description
Proportion of subjects who have freedom from their most bothersome symptom (MBS) at two hours after initiation of treatment.
Time Frame
2 hours post initiation of treatment
Title
Significant relief from headache pain
Description
Proportion of subjects who have significant relief from headache pain 2 hours after initiation of treatment.
Time Frame
2 hours post initiation of treatment
Title
Pain freedom at end of treatment
Description
Proportion of subjects who are free from headache pain at the end of treatment.
Time Frame
Immediately post treatment of 20-40 minutes
Title
Significant headache relief at the end of treatment
Description
Proportion of subjects who have significant headache pain relief at the end of treatment.
Time Frame
Immediately post treatment of 20-40 minutes
Title
Sustained pain freedom
Description
Proportion of subjects with sustained freedom from headache pain from 2 hours to 24 hours after initiation of treatment.
Time Frame
24 hours post initiation of treatment
Title
Significant relief of most bothersome symptom
Description
Proportion of subjects who have significant relief from their most bothersome symptom (MBS) 2 hours after initiation of treatment.
Time Frame
2 hours post initiation of treatment
Title
Use of rescue meds prior to 24 hours post treatment
Description
Proportion of subjects who use rescue medications prior to 24 hours post treatment
Time Frame
24 hours post treatment
Title
Overall satisfaction
Description
Overall satisfaction at post-treatment phase using a modified version of the Revised Patient Perception of Migraine Questionnaire (PPMQ-R)
Time Frame
Post treatment phase (45 days)
Title
Functional compromise freedom
Description
Proportion of subjects who are free of migraine related functional compromise 2 hours after initiation of treatment.
Time Frame
2 hours post initiation of treatment
Title
Proportion active treatments achieving pain freedom
Description
Proportion of all active treatments that achieved pain freedom by end of treatment or at 2 hours from starting treatment.
Time Frame
End of treatment or at 2 hours post initiation of treatment
Title
Proportion active treatments achieving pain freedom at end of treatment
Description
Proportion of all active treatments that achieved significant pain relief by end of treatment or at 2 hours from starting treatment
Time Frame
Immediately post treatment of 20-40 minutes
Title
Proportion of first randomized active vs first open-label achieving pain freedom
Description
Proportion of first randomized active treatments vs. first open label active treatments that achieve headache pain freedom at 2 hours from starting treatment.
Time Frame
2 hours post initiation of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David George
Phone
4803021215
Email
david@nocira.com
First Name & Middle Initial & Last Name or Official Title & Degree
Melissa Walker, MS RAC FRAPS
Phone
3147537790
Email
mwalker@nocira.com
Facility Information:
Facility Name
ReGen Pain & Wellness
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260-1911
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keith Smigiel, FNP-C DC
Phone
480-341-5174
Email
drkeith@msn.com
First Name & Middle Initial & Last Name & Degree
Keith Smigiel, FNP-C DC
Facility Name
StudyMetrix
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mitzi Sutton
Phone
636-387-5100
First Name & Middle Initial & Last Name & Degree
Tim Smith, MD
Phone
6363875100
Email
tsmith@studymetrix.com
First Name & Middle Initial & Last Name & Degree
Timothy Smith, MD
Facility Name
ClinVest
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David True, DO

12. IPD Sharing Statement

Plan to Share IPD
No

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AVPI Migraine Study

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