Partial Rebreathing Device for Migraine

(PAREMA1 Trial)

No longer recruiting at 19 trial locations

Overseen By Sónia Ferreira

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rehaler

Must not be taking: Nerve blocks

Disqualifiers: Chronic pulmonary, Cardiovascular, Cerebrovascular, others

Compensation: Varies

Number of Visits: Unknown

Duration: 2 hours per treatment session

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Rehaler Partial Rebreathing Device, designed to assist adults who experience migraines with aura (visual disturbances before a headache). The study aims to determine if the device is safe and effective in reducing migraine symptoms. Participants will use either the active Rehaler device or a sham (inactive) device to compare outcomes. Ideal candidates have experienced at least three migraines with aura in the past six months and suffer moderate to severe headaches shortly after the aura begins. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new migraine treatments.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current migraine prevention medications, but you must not change the dose during the study. You should also wait at least two hours after using the study device before taking your usual acute migraine medications.

What prior data suggests that the Rehaler partial rebreathing device is safe for adults with migraine with aura?

Research has shown that the Rehaler Partial Rebreathing Device is generally safe for people with migraines. In one study, patients used the device and experienced no negative side effects, with side effects either absent or very mild. Another study also found no negative side effects with the device. These findings suggest that users tolerate the Rehaler device well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard migraine treatments, which often involve medications like triptans or beta-blockers, the Rehaler Partial Rebreathing Device offers a non-drug approach. This device is unique because it uses controlled breathing to potentially reduce migraine symptoms by adjusting carbon dioxide levels in the blood, which can influence brain blood flow. Researchers are excited about this method because it could provide relief without the side effects associated with medications, offering a new option for those who cannot tolerate or prefer not to use traditional drugs.

What evidence suggests that the Rehaler partial rebreathing device is effective for migraines?

Research has shown that the Rehaler Partial Rebreathing Device, which participants in this trial may receive, can help with migraines, particularly those with aura—visual or sensory changes before a migraine starts. An initial study found that this device significantly increased the number of migraine attacks where pain was relieved within two hours of use. The device raises carbon dioxide levels in the blood, which might help ease migraine symptoms. Studies have also found that using the device did not cause any serious side effects and kept oxygen levels stable. Early results suggest that the device becomes more effective with increased use. Participants in this trial may also receive a Sham Breathing Device as a comparator. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

Adults aged 18-65 who've had at least three migraine-with-aura attacks in the last six months can join. They must have a history of migraines starting before age 50, not be on new or changing migraine prevention drugs, and agree to delay usual migraine meds post-treatment. No chronic lung or severe heart diseases allowed, nor those with certain neurological conditions.

Inclusion Criteria

I have had at least 3 migraines with aura in the past 6 months.

Participant owns a smartphone compatible with the ePRO study diary app

Participant is willing and able to provide written informed consent

Exclusion Criteria

I am currently pregnant or trying to conceive.

Participant is participating in any other clinical investigation or has participated in an interventional clinical trial in the preceding 30 days

Participant belongs to a vulnerable population or has any condition such that his or her ability to provide informed consent, comply with the follow-up requirements, or provide self-assessments is compromised (e.g. homeless, developmentally disabled, prisoner)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Rehaler partial rebreathing device to treat migraine with aura

2 hours per treatment session

Multiple sessions as needed for migraine attacks

Follow-up

Participants are monitored for safety and effectiveness after treatment

48 hours post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Rehaler Partial Rebreathing Device
• Sham Breathing Device

Trial Overview The trial is testing the Rehaler partial rebreathing device against a sham (fake) device for safety and effectiveness in treating migraines with aura. Participants are randomly assigned to one of these two groups without knowing which one they're in.

How Is the Trial Designed?

Group I: Active device Active Control 1 Intervention

Group II: Sham device Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Rehaler

Lead Sponsor

Trials

3

Recruited

170+

Qmed Consulting A/S

Industry Sponsor

Trials

6

Recruited

2,100+

Published Research Related to This Trial

Inhalation therapy for migraine treatment, particularly with MAP0004 (inhaled dihydroergotamine mesylate), has shown promising efficacy and better tolerability compared to traditional parenteral methods, based on phase 3 studies.

Inhaled prochlorperazine demonstrated good pharmacokinetics and efficacy in phase 2 trials, while inhaled loxapine did not show encouraging results, indicating variability in effectiveness among inhaled migraine treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The discovery and development of inhaled therapeutics for migraine. Vandenbussche, N., Goadsby, PJ.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30134739/

Treatment of acute migraine by a partial rebreathing device A marked efficacy increase was seen from first to second time use of the partial rebreathing device. No adverse events occurred, and side ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/85/NCT05546385/Prot_000.pdf

PArtial REbreathing for Migraine with Aura 1 (PAREMA1): The primary objective of the study is to assess the effectiveness and safety of the Rehaler device as treatment of migraine with aura when used ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6158684/

Treatment of acute migraine by a partial rebreathing device The partial rebreathing device increased mean End Tidal CO2 by 24%, while retaining mean oxygen saturation above 97%. ... A marked efficacy ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05546385

NCT05546385 | PArtial REbreathing for Migraine With Aura 1 ... Effectiveness of the Rehaler Partial Rebreathing Device, in Adults Suffering From Migraine With Aura. Conditions. Migraine With Aura. Migraine With Aura.

5. withpower.com withpower.com/trial/phase-migraine-disorders-9-2022-3f128

Partial Rebreathing Device for Migraine (PAREMA1 Trial) A pilot study showed that the Partial Rebreathing Device significantly increased the percentage of migraine attacks with pain relief two hours after treatment ...

6. clinicaltrials.stanford.edu clinicaltrials.stanford.edu/trials/p/NCT05546385.html

PArtial REbreathing for Migraine With Aura 1 ... Safety and Effectiveness of the Rehaler Partial Rebreathing Device, in Adults Suffering From Migraine With Aura. Stanford Investigator(s). Leon S. Moskatel ...