What side effects are associated with this type of intervention?

Common treatments for migraines that affect cerebral blood flow, such as sumatriptan and ergotamine, have several known side effects. Sumatriptan can cause vasoconstriction, leading to potential cardiovascular issues, and may result in sensations of tingling, warmth, dizziness, or tightness in the chest. Ergotamine, on the other hand, is associated with risks of sustained coronary artery constriction, peripheral vascular disease, and increased chances of cerebrovascular and cardiovascular complications, especially in patients with pre-existing conditions. Both medications can lead to medication overuse headaches if taken excessively.

What prior FDA approvals exist?

The FDA has approved several treatments for migraines, including triptans (e.g., sumatriptan), which are serotonin receptor agonists that help reduce inflammation and constrict blood vessels. Additionally, non-invasive neuromodulation devices like transcranial magnetic stimulation (TMS) and noninvasive vagus nerve stimulation (nVNS) have been approved for acute migraine treatment. These devices modulate neural activity to alleviate migraine symptoms. While specific FDA approvals for devices that alter blood gas levels like the Rehaler are not detailed, the focus on cerebral blood flow modulation is a common therapeutic target in migraine management.

What other types of research exist?

Promising novel alternatives to the Rehaler partial rebreathing device for migraine patients include: 1) Neuromodulation devices such as transcutaneous supraorbital neurostimulation (e.g., Cefaly) and non-invasive vagus nerve stimulation (e.g., gammaCore). 2) CGRP (calcitonin gene-related peptide) monoclonal antibodies (e.g., erenumab, fremanezumab) which have shown efficacy in preventing migraines. 3) Ditans (e.g., lasmiditan), a new class of acute migraine treatment that targets serotonin receptors without vasoconstriction.

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Behavioural Intervention

Partial Rebreathing Device for Migraine (PAREMA1 Trial)

N/A

Recruiting

Research Sponsored by Rehaler

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 hours

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, participants will be monitored for any adverse reactions due to using the Rehaler device compared to the sham breathing device.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain

Secondary study objectives

Attacks with use of rescue medication from the 2 hours' time point until 24 hours (Res24)

Freedom from Most Bothersome Symptom at 2 hours (MBSF2)

Freedom from Relapse at 48 hours (FR48)

+9 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active deviceActive Control1 Intervention

Group II: Sham devicePlacebo Group1 Intervention

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Rehaler partial rebreathing device works by altering levels of carbon dioxide and oxygen in the blood, which can affect cerebral blood flow and potentially alleviate migraine symptoms. This mechanism is based on the idea that changes in blood gas levels can influence the dilation and constriction of cerebral blood vessels, which are thought to play a role in migraine pathophysiology. Other common treatments for migraines include triptans, which target serotonin receptors to reduce inflammation and constrict blood vessels, and antiemetics like metoclopramide, which can relieve nausea and enhance the effectiveness of other medications. Understanding these mechanisms is crucial for migraine patients as it helps tailor treatment plans to their specific needs and improves the likelihood of effective symptom management.

Trans-nasal high-flow dehumidified air in acute migraine headaches: A randomized controlled trial.Migraine: current therapeutic targets and future avenues.Cerebrovascular reactivity in migraine during headache-free intervals.