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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
Awards & highlights
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
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 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active deviceActive Control1 Intervention
Group II: Sham devicePlacebo Group1 Intervention
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.
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.
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Who is running the clinical trial?
Qmed Consulting A/SIndustry Sponsor
5 Previous Clinical Trials
1,925 Total Patients Enrolled
RehalerLead Sponsor
2 Previous Clinical Trials
24 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had at least 3 migraines with aura in the past 6 months.I am currently pregnant or trying to conceive.I have Sickle Cell Disease.I have had brain surgery or a stent placed in my brain.I am between 18 and 65 years old.I have had a cerebral aneurysm in the past.I have had serious heart or stroke-related health issues.I have had issues with very high or very low brain pressure.I experience headaches on 15 or more days each month.I have been diagnosed with hemiplegic migraine.I have a long-term lung condition like COPD or pulmonary fibrosis.My hemoglobin level is below 11g/dL.I agree to use the study device, follow all study rules, and record data in the app.I have a significant pain condition like cancer pain or fibromyalgia.I agree to wait at least 2 hours after using the study device before taking my usual migraine medication.I experience severe headaches following aura in most of my migraine episodes.I have recurring headaches that might affect the study.My migraine prevention medication dose has been the same for at least 3 months.My migraines with aura started before I was 50.I won't start or change migraine prevention meds during the first study stage.I have headaches from using too much medication.My migraines with aura started before I turned 50.I experience severe headaches following aura in most of my migraines.I have had at least 3 migraines with aura in the past 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Active device
- Group 2: Sham device
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Migraine Patient Testimony for trial: Trial Name: NCT05546385 — N/A
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