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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
PAREMA1 Trial Summary
This trial is testing a device that may help with migraine with aura by partially rebreathing.
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.Check my eligibility
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.See study design
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.
PAREMA1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain
Secondary outcome measures
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 morePAREMA1 Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active deviceActive Control1 Intervention
Group II: Sham devicePlacebo Group1 Intervention
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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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the necessary criteria for enrolling in this trial?
"This clinical trial is recruiting 175 individuals aged 18 to 65 who are afflicted with migraine aura. In order for participants to be eligible, they must meet a number of criteria including: having an onset age of less than 50 years old, abstaining from acute medication intake until at least two hours after treatment, no initiation or changes in prophylactic medications over the duration of stage 1, typical ICHD3 classified migraines that lead into moderate/severe headaches within 10-60 minutes post-onset in more than 75% of cases during the last 6 months; if on any form of prophylaxis it must have been"
Answered by AI
Does this medical trial allow those aged 55 and up to participate?
"This clinical trial is available for patients aged between 18 and 65. For those younger than the age of consent, there are 32 trials running in parallel; for individuals beyond pensionable age, 110 studies have been scheduled."
Answered by AI
Are any fresh participants being sought for this trial?
"Based on the information available at clinicaltrials.gov, this medical trial is not presently recruiting participants, having first been posted in October 1st 2022 and last edited September 27th. Unfortunately for prospective patients, there are 165 other studies that are actively searching for volunteers right now."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
Stanford University
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
I would like to never have another Migraine for as long as I live.
PatientReceived 1 prior treatment
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Email
Most responsive sites:
- Stanford University: < 48 hours
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