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Device

AVPI Device for Migraine (NC06 Trial)

N/A
Recruiting
Research Sponsored by Nocira, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Typical untreated migraines are historically at least moderate to severe, by patient report
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately post treatment of 20-40 minutes
Awards & highlights

NC06 Trial Summary

This trial tests the safety and effectiveness of a device for treating migraines in two stages: an in-clinic evaluation and home use.

Who is the study for?
Adults aged 18-75 with a history of migraines, experiencing 2-10 attacks per month. Participants must not be in other trials, should have stable migraine medication for 3 months if applicable, and need internet access via mobile device. Excluded are pregnant individuals, those unable to distinguish migraine types or follow instructions, with certain ear conditions or significant medical issues that could affect the study.Check my eligibility
What is being tested?
The AVPI Device is being tested for its effectiveness in treating acute migraines. The trial has two phases: an initial screening (Phase I) where the device's operation is checked under supervision and a home-use evaluation (Phase II). It's a double-blind study meaning neither participants nor researchers know who gets the real treatment versus a sham (fake) one.See study design
What are the potential side effects?
While specific side effects aren't listed here, potential risks may include discomfort from wearing the device or reactions related to incorrect use. As it's non-invasive and doesn't involve drugs, traditional medication side effects are unlikely.

NC06 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have 2-10 migraines per month and no more than 20 headache days per month on average over the last 3 months.
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Your migraines are usually at least moderately severe when you haven't taken any medicine for them.
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You are between 18 and 75 years old and have had migraines for at least one year that match certain medical criteria.
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You started getting migraines before you were 50 years old.

NC06 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately post treatment of 20-40 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately post treatment of 20-40 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Headache Pain Freedom
Secondary outcome measures
Freedom from the most bothersome symptom (MBS)
Functional compromise freedom
Overall satisfaction
+9 more

NC06 Trial Design

3Treatment groups
Experimental Treatment
Group I: Group 2 Home TreatmentExperimental Treatment1 Intervention
Randomized active or sham for first home treatment followed by open-label treatments in the home environment.
Group II: Group 1b Clinic & Home TreatmentExperimental Treatment1 Intervention
Open-label, active treatment for subjects treated in prior clinical trials for this device, followed by open-label treatments in the home environment.
Group III: Group 1a Clinic TreatmentExperimental Treatment1 Intervention
Randomized, active or sham in-clinic treatment during a migraine, followed by open-label treatments in the home environment.

Find a Location

Who is running the clinical trial?

Nocira, LLCLead Sponsor
1 Previous Clinical Trials
80 Total Patients Enrolled
1 Trials studying Migraine
80 Patients Enrolled for Migraine

Media Library

AVPI Device (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05537818 — N/A
Migraine Research Study Groups: Group 1a Clinic Treatment, Group 1b Clinic & Home Treatment, Group 2 Home Treatment
Migraine Clinical Trial 2023: AVPI Device Highlights & Side Effects. Trial Name: NCT05537818 — N/A
AVPI Device (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05537818 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available slots that participants can enroll in for this experiment?

"Affirmative. According to clinicaltrials.gov, this clinical trial is presently searching for contenders. It was initially published on June 30th 2022 and recently amended on November 25th of the same year. 80 patients need to be gathered from 3 distinct sites."

Answered by AI

Are members of the geriatric population being included in this trial?

"The enrollment qualifications for this medical research stipulate that the minimum age requirement is 18 and the maximum upper limit of eligibility is 75."

Answered by AI

How many people are participating in this clinical experiment?

"Affirmative. According to the information hosted on clinicaltrials.gov, this trial initiated in June 2022 and is actively recruiting patients at present. 80 participants are needed from 3 medical facilities for it to move forward properly."

Answered by AI

May I apply to participate in this research trial?

"This trial is enrolling 80 persons aged eighteen to seventy-five afflicted by migraines. Candidates must meet the following considerations: having signed an informed consent form, access to a wireless internet connection, 1 year history of migraine symptoms congruent with ICHD-3 criteria prior to age fifty, willingness and capacity for taking part in baseline and follow up evaluations without concurrent participation in another clinical trial, self reported moderate or severe episodes at least two times per month on average over three months preceding study entry; prophylactic medication users need have been using stable doses for no less than 3 months preceeding enrolment and remain"

Answered by AI
~30 spots leftby Mar 2025