PArtial REbreathing for Migraine With Aura 1 (PAREMA1)

April 18, 2024 updated by: Rehaler

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

175

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Troels Johansen, Ph.D.
  • Phone Number: +4540977313
  • Email: tj@rehaler.com

Study Locations

  • Germany
  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford University - Stanford Headache Clinic
        • Contact:
        • Principal Investigator:
          • Leon Moskatel
      • Pasadena, California, United States, 91105
        • Recruiting
        • Profound Research-Southern California Neurology Consultants
        • Contact:
        • Principal Investigator:
          • Arbi Ohanian
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Recruiting
        • Yale University
        • Contact:
        • Principal Investigator:
          • Christopher Gottschalk
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
    • Florida
      • Miami, Florida, United States, 33136
        • Not yet recruiting
        • University of Miami
        • Contact:
        • Principal Investigator:
          • Teshamae Monteith
    • Missouri
      • Springfield, Missouri, United States, 65807
        • Recruiting
        • Clinvest Research
        • Contact:
        • Principal Investigator:
          • David True
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 33136
        • Recruiting
        • Thomas Jefferson University Hospital
        • Contact:
        • Principal Investigator:
          • Stephanie Nahas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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.
  2. Participant has had 3 or more migraine-with-aura attacks over the last six months.
  3. Participant is 18 to 65 years of age.
  4. Participant's age at onset of migraine with aura was less than 50 years.
  5. If participant is taking migraine prophylactic drugs, the dose must have been stable for three months or more.
  6. Participant agrees to withhold usual acute migraine medications until at least two hours after treatment with the study device.
  7. Participant does not plan to initiate new (and/or change existing) migraine prophylaxis medication for the duration of Stage 1 of the study, or receive nerve blocks, injections or neurostimulation for migraine prophylaxis for the duration of Stage 1 of the study.
  8. For female participants: is willing to use adequate contraception during study participation
  9. Participant owns a smartphone compatible with the ePRO study diary app.
  10. 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.
  11. Participant is willing and able to provide written informed consent.

Exclusion Criteria:

  1. Participant has a history of chronic pulmonary disease (e.g. Chronic Obstructive Pulmonary Disease (COPD) or pulmonary fibrosis).
  2. 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).
  3. Participant has a history of intracranial hyper/hypo-tension.
  4. Participant has a history of cerebral aneurysm.
  5. Participant has had previous brain surgery, including stenting.
  6. Anaemia, defined as a hemoglobin concentration in capillary blood lower than 11g/dL
  7. Participant has a baseline SPO2 level which is lower than 95% performed at Site Visit 1.
  8. Participant has 15 or more headache days per month
  9. Participant has medication-overuse headache (ICHD3 classification 8.2).
  10. Participant has a known history or suspicion of recurring secondary headache which in the opinion of the investigator may interfere with the study.
  11. Hemiplegic migraine
  12. Participant has other significant and relevant pain problem (e.g. cancer pain, fibromyalgia or other head or facial pain disorders)
  13. Participant has a known history or suspicion of substance abuse or addiction (within the last 5 years) that in the opinion of the investigator may confound the study assessments.
  14. Participant has a history of psychiatric or cognitive disorder and/or behavioural problems which in the opinion of the investigator may interfere with the study.
  15. 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).
  16. For female participants: is pregnant or actively trying to become pregnant.
  17. Participant is participating in any other clinical investigation or has participated in an interventional clinical trial in the preceding 30 days.
  18. Participant has any condition that according to the investigator may pose the participant at risk or provide confounding data.
  19. Participant is unable, as perceived by study personnel, to correctly understand and follow the instructions for use of the device and ePRO app.
  20. Sickle Cell Disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active device
Device: Partial Rebreathing Device
Partial Rebreathing Device
Placebo Comparator: Sham device
Device: Sham breathing device
Sham breathing device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absence of moderate or severe pain at 2 hours (AMSP2)
Time Frame: 2 hours
The proportion of attacks in which the participant reported absence of headache of moderate or severe intensity at 2 hours post-treatment initiation
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Freedom at 2 hours (PF2)
Time Frame: 2 hours
The proportion of attacks with absence of headache pain two hours after treatment initiation
2 hours
Freedom from Most Bothersome Symptom at 2 hours (MBSF2)
Time Frame: 2 hours
The proportion of attacks with absence of MBS two hours after treatment initiation
2 hours
Sustained Pain Freedom at 24 hours (SPF24)
Time Frame: 24 hours
The proportion of attacks having no headache pain at 2 hours after treatment initiation, with no use of rescue medication and no relapse of headache pain within 24 hours
24 hours
Headache Score at 2 hours (HS2)
Time Frame: 2 hours
Headache Score 2 hours after treatment initiation (four-point scale)
2 hours
Most Bothersome Symptom Score at 2 hours (MBS2)
Time Frame: 2 hours
Most Bothersome Symptom score two hours after treatment initiation (four-point scale)
2 hours
Functional Disability Score at 2 hours (FDS2)
Time Frame: 2 hours
Functional Disability Score two hours after treatment initiation (four-point scale)
2 hours
Participant Satisfaction at 48 hours (PS48)
Time Frame: 48 hours
Participant's global impression of acute treatment effect on attack, evaluated at 48 hours after treatment initiation (5 point scale: 5 = Satisfied, 4 = Partially Satisfied, 3 = Neutral, 2 = Partially Unsatisfied, 1 = Unsatisfied)
48 hours
Light Sensitivity Score at 2 hours (LSS2)
Time Frame: 2 hours
Photophobia score two hours after treatment initiation (four-point scale)
2 hours
Nausea Score at 2 hours (NS2)
Time Frame: 2 hours
Nausea Score two hours after treatment initiation (four-point scale)
2 hours
Sound Sensitivity Score at 2 hours (SSS2)
Time Frame: 2 hours
Phonophobia score two hours after treatment initiation (four-point scale)
2 hours
Freedom from Relapse at 48 hours (FR48)
Time Frame: 48 hours
The proportion of attacks having no headache pain at 2 hours after dose, with no use of rescue medication and no relapse of headache pain within 48 hours
48 hours
Attacks with use of rescue medication from the 2 hours' time point until 24 hours (Res24)
Time Frame: 24 hours
The proportion of attacks with use of rescue medication from the 2 hours' time point until 24 hours (Res24)
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rehaler

Collaborators

Qmed Consulting A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2023

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

September 14, 2022

First Submitted That Met QC Criteria

September 14, 2022

First Posted (Actual)

September 19, 2022

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RH-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Migraine With Aura

Clinical Trials on Partial Rebreathing Device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Arab Emirates

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe