A Prospective, Multi-centre, Randomized, Double-blind, Sham-controlled, Parallel-group, Group-sequential Study to Investigate Safety and Effectiveness of the Rehaler Partial Rebreathing Device, in Adults Suffering From Migraine With Aura

Rehaler15 sites in 2 countries142 target enrollmentAugust 8, 2023

Overview

Phase: N/A
Intervention: Not specified
Conditions: Not specified
Sponsor: Rehaler
Enrollment: 142
Locations: 15
Primary Endpoint: Absence of Moderate or Severe Pain at 2 Hours (AMSP2)
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A prospective, multi-centre, randomized, double-blind, sham-controlled, parallel-group, group-sequential study to investigate safety and effectiveness of the Rehaler partial rebreathing device, in adults suffering from migraine with aura

Registry

clinicaltrials.gov

Start Date

August 8, 2023

End Date

October 30, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Rehaler

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participant has migraine with typical aura (ICHD3 classification 1.2.1) with the additional criterion that historically in more than 75% of cases of aura a moderate or severe headache begins between 10 and 60 minutes after aura onset.
•Participant has had 3 or more migraine-with-aura attacks over the last six months.
•Participant is 18 to 65 years of age.
•Participant's age at onset of migraine with aura was less than 50 years.
•If participant is taking migraine prophylactic drugs, the dose must have been stable for three months or more.
•Participant agrees to withhold usual acute migraine medications until at least two hours after treatment with the study device.
•Participant does not plan to initiate new (and/or change existing) migraine prophylaxis medication for the duration of Stage 1 of the study.
•For female participants: is willing to use adequate contraception during study participation
•Participant owns a smartphone compatible with the ePRO study diary app.
•Participant agrees to use the study device as intended, comply with all study requirements including treatment, follow-up visits, and recording required study data in the ePRO app.

Exclusion Criteria

•Participant has a history of chronic pulmonary disease (e.g. Chronic Obstructive Pulmonary Disease (COPD) or pulmonary fibrosis).
•Participant has a history of severe cardiovascular disease (e.g. symptomatic coronary artery disease, prior myocardial infarction, congestive heart failure) or cerebrovascular disease (e.g. prior stroke or transient ischemic attack, symptomatic carotid artery disease, prior carotid endarterectomy or other vascular neck surgery).
•Participant has a history of intracranial hyper/hypo-tension.
•Participant has a history of cerebral aneurysm.
•Participant has had previous brain surgery, including stenting.
•Anaemia, defined as a hemoglobin concentration in capillary blood lower than 11g/dL
•Participant has a baseline SPO2 level which is lower than 95% performed at Site Visit
•Participant has 15 or more headache days per month
•Participant has medication-overuse headache (ICHD3 classification 8.2).
•Participant has a known history or suspicion of recurring secondary headache which in the opinion of the investigator may interfere with the study.

Outcomes

Primary Outcomes

Absence of Moderate or Severe Pain at 2 Hours (AMSP2)

Time Frame: 2 hours

The percentage of attacks in which the participant reported absence of headache of moderate or severe intensity at 2 hours post-treatment initiation

Secondary Outcomes

Pain Freedom at 2 Hours (PF2)(2 hours)
Freedom From Most Bothersome Symptom at 2 Hours (MBSF2)(2 hours)
Sustained Pain Freedom at 24 Hours (SPF24)(24 hours)
Headache Score at 2 Hours (HS2)(2 hours)
Most Bothersome Symptom Score at 2 Hours (MBS2).(2 hours)
Functional Disability Score at 2 Hours (FDS2)(2 hours)
Light Sensitivity Score at 2 Hours (LSS2)(2 hours)
Attacks With Use of Rescue Medication From the 2 Hours' Time Point Until 24 Hours (Res24)(24 hours)
Participant Satisfaction at 48 Hours (PS48)(48 hours)
Nausea Score at 2 Hours (NS2)(2 hours)
Sound Sensitivity Score at 2 Hours (SSS2)(2 hours)
Freedom From Relapse at 48 Hours (FR48)(48 hours)