AVPI Device for Migraine

(NC06 Trial)

Not currently recruiting at 2 trial locations

Overseen By Melissa Walker, MS RAC FRAPS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nocira, LLC

Must be taking: Prophylactic migraine medication

Must not be taking: Opioids, Barbiturates

Disqualifiers: Pregnancy, Hypertension, Ear disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the AVPI Device to determine its safety and effectiveness in treating migraines. Participants will use the device either in a clinic or at home to evaluate its performance against a sham version. As a double-blind study, neither participants nor researchers know who uses the real device during the initial phase. Ideal candidates have experienced migraines for at least one year, suffer from 2-10 migraine attacks per month, and often find their untreated migraines moderate to severe. Participants must be able to use a smartphone or computer with internet access for study communications. As an unphased trial, this study allows participants to contribute to innovative migraine treatment research.

Will I have to stop taking my current medications?

If you are on preventive migraine medication, you must have been on a stable dose for at least 3 months before joining the study and continue with the same dose during the study. If you use acute migraine medication, you should not have taken it via IV infusion within two weeks before screening, and you should not use it within 24 hours before each treatment.

What prior data suggests that the AVPI Device is safe for treating migraines?

Research has shown that the AVPI Device is generally safe for use. In a real-world study, only 0.48% of users reported side effects related to the device, and these were mostly mild. Another study found that users considered the AVPI Device safe and effective for quickly relieving migraines. Other studies using similar technology found no safety issues. Overall, current evidence suggests that the AVPI Device is safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the AVPI Device for migraines because it offers a novel, non-invasive approach to managing this condition. Unlike standard treatments, which often rely on medications like triptans or anti-inflammatory drugs, the AVPI Device uses a unique mechanism involving neuromodulation to potentially alleviate migraine symptoms quickly. This device can be used both in clinical settings and at home, providing flexibility and convenience that is not typically available with traditional migraine medications. By offering an alternative that avoids medication side effects and provides on-demand relief, the AVPI Device represents a promising advancement in migraine care.

What evidence suggests that the AVPI Device is effective for treating migraines?

Research shows that the Nocira AVPI Device effectively treats migraines. Studies found that this device uses a type of nerve stimulation to relieve pain in about 66.5% of patients, meaning more than half experienced relief from migraine pain. The device also alleviates other migraine symptoms. As a non-invasive treatment, it doesn't require surgery or entering the body, offering a safer option for many. These results suggest that the AVPI Device could be a promising choice for those suffering from migraines. Participants in this trial will join different groups to evaluate the device's effectiveness in both clinic and home settings. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Subjects must have wireless access to the internet via mobile computing or smartphone device for audio and/or video contacts

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

Willingness, ability, and commitment to participate in baseline and follow-up evaluations without concurrent participation in another clinical trial

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Phase I - Clinic Treatment

Initial screening of device operation in both active and sham modes in-clinic and as proctored by the investigator

45 days

Multiple visits (in-person)

Phase II - Home Treatment

Further evaluation of the device when used in the home (non-clinical) environment

45 days

Home-based treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AVPI Device

Trial Overview 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.

How Is the Trial Designed?

Group I: Group 2 Home Treatment Experimental Treatment 1 Intervention

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

Group II: Group 1b Clinic & Home Treatment Experimental Treatment 1 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 Treatment Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Nocira, LLC

Lead Sponsor

Trials

2

Recruited

160+

Published Research Related to This Trial

Implanting the pulse generator (IPG) closer to the lead location, such as in the infraclavicular region, significantly reduces the incidence of adverse events (AEs) related to peripheral nerve stimulation (PNS) for chronic migraine management, indicating a safer surgical approach.

Increased experience of the implanter, measured by the number of prior PNS implants performed, is associated with a lower rate of stimulation- and hardware-related AEs, suggesting that skill and precision improve with practice, leading to better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of adverse events in the management of chronic migraine by peripheral nerve stimulation. Sharan, A., Huh, B., Narouze, S., et al.[2022]

Nerivio™, a noninvasive remote electrical neuromodulation device, has shown high efficacy and a favorable safety profile in treating acute migraine, as supported by two randomized trials.

The device works by applying electrical stimulation to peripheral nerves in the upper arm, offering a novel mechanism of action that may reduce the risk of medication overuse headaches and improve the quality of life for migraine sufferers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Device profile of the Nerivio™ for acute migraine treatment: overview of its efficacy and safety. Rapoport, AM., Lin, T.[2020]

Remote electrical neuromodulation (REN) is an effective and safe treatment for acute migraine, with 66.5% of patients achieving pain relief in at least half of their treatments, based on data from 23,151 treatments across 2,514 patients.

The device was primarily used as a standalone treatment (66.5% of cases), and adverse events were rare, with only 0.48% of users reporting device-related issues, mostly mild in nature.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Analysis of Remote Electrical Neuromodulation (REN) for the Acute Treatment of Migraine. Ailani, J., Rabany, L., Tamir, S., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05537818

Study Details | NCT05537818 | AVPI Migraine Study 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 ...

2. migrainedisorders.org migrainedisorders.org/podcast/s2ep21-nocira-migraine-treatment/

% S2:Ep21 - Nocira's Promising New Device for Migraine The Nocira AVPI treatment also showed high success rates in the majority of patients for treating other primary associated migraine symptoms of ...

3. withpower.com withpower.com/trial/phase-b676a

AVPI Device for Migraine (NC06 Trial) Remote electrical neuromodulation (REN) is an effective and safe treatment for acute migraine, with 66.5% of patients achieving pain relief in at least half of ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02991430

A Non-Invasive Neuromodulation Device for Prevention of ... Study Overview. Brief Summary. This study will assess the efficacy of a neuromodulation device for the treatment of episodic migraine headache.

5. biospace.com biospace.com/nocira-becomes-first-company-ever-to-announce-and-quot-breakthrough-device-and-quot-designation-by-the-fda-for-acute-treatment-of-migraine

NOCIRA® Becomes First Company Ever to Announce ... Nocira's Breakthrough Device designation was supported by peer-reviewed, published clinical data from a 59 patient, randomized, placebo or "sham ...

6. ctv.veeva.com ctv.veeva.com/study/automated-variable-pattern-insufflator-device-avpi-for-the-acute-treatment-of-migraine

Automated Variable Pattern Insufflator Device (AVPI) for the ... Randomized, sham-controlled, double-blind study for acute migraine attacks. Randomized to active treatment and sham treatment arms for the ...