Partial Rebreathing Device for Migraine

(PAREMA1 Trial)

Recruiting at 17 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

142 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing the Rehaler, a breathing device, to see if it can help adults who have migraines with aura. The device works by letting users rebreathe some of their exhaled air, which might change blood gas levels and reduce migraine symptoms.

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 data supports the effectiveness of the Partial Rebreathing Device for treating migraines?

A pilot study showed that the Partial Rebreathing Device significantly increased the percentage of migraine attacks with pain relief two hours after treatment and had high user satisfaction, suggesting it may be a promising alternative or additional treatment for migraines. ^{1 2 3 4 5}

Is the Partial Rebreathing Device safe for use in humans?

In a pilot study, the Partial Rebreathing Device was used by migraine patients and showed no adverse events, with side effects being absent or mild, indicating it is generally safe for human use. ^{1 2 6 7 8}

How does the Rehaler Partial Rebreathing Device treatment for migraine differ from other treatments?

The Rehaler Partial Rebreathing Device is unique because it uses normoxic hypercapnia (increased carbon dioxide levels without reducing oxygen levels) to improve brain oxygen delivery, which can help relieve migraine symptoms. This approach is different from traditional drug treatments, as it involves a non-drug, device-based method to manage migraines. ^{1 2 3 5 9}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Treatment of acute migraine by a partial rebreathing device: A randomized controlled pilot study. [2019]

2. England pubmed.ncbi.nlm.nih.gov

The discovery and development of inhaled therapeutics for migraine. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, placebo-controlled study of breath powered nasal delivery of sumatriptan powder (AVP-825) in the treatment of acute migraine (The TARGET Study). [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Assessment of the consistency of absorption of dihydroergotamine following oral inhalation: pooled results from four clinical studies. [2013]

5. England pubmed.ncbi.nlm.nih.gov

Inhaled drug therapy development for the treatment of migraine. [2018]

6. England pubmed.ncbi.nlm.nih.gov

The safety of sumatriptan in asthmatic migraineurs. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

Orally inhaled dihydroergotamine: a review. [2013]

8. England pubmed.ncbi.nlm.nih.gov

Randomized, double-blind, placebo-controlled study of the safety, tolerability and pharmacokinetics of MAP0004 (orally-inhaled DHE) in adult asthmatics. [2019]

9. England pubmed.ncbi.nlm.nih.gov

MAP0004: dihydroergotamine mesylate inhalation aerosol for acute treatment of migraine. [2013]