Partial Rebreathing in the Treatment of Migraine With Aura
CapnoMigra
1 other identifier
interventional
18
1 country
1
Brief Summary
A study to test the efficacy of a partial rebreathing device in treating and/or preventing migraine pain
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedFirst Posted
Study publicly available on registry
March 21, 2018
CompletedMarch 23, 2018
November 1, 2016
10 months
May 2, 2017
March 21, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Headache Intensity Difference at 0 vs 2 hours post-treatment
0-3 point scale (0 = none, 1 = mild, 2= moderate, 3 =severe)
2 hours
Secondary Outcomes (15)
Headache Intensity Difference at 0 and 1 hour post-treatment (0-3 point scale)
1 hour
Pain reduction/relief at 1 hour
1 hour
Pain reduction/relief at 2 hours
2 hours
Nausea Intensity Difference 0 vs 1 hour post-treatment
1 hour
Nausea Intensity Difference 0 vs 2 hours post-treatment
2 hours
- +10 more secondary outcomes
Study Arms (2)
Active partial rebreathing device
ACTIVE COMPARATORDummy partial rebreathing device
SHAM COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- \- Migraine with aura
- Attack frequency of between one and six migraine-with-aura attacks per month over the last six months
- Adults (18-60 years)
- Age at onset of migraine \< 50 years
- If taking migraine prophylactic drugs, the dosis must have been stable for \> 3 months
- Must speak and understand Danish
You may not qualify if:
- \- Cardiovascular disease, pulmonary disease, metabolic acid/base disorder, cancer, moderate and severe depression, anemia or other blood disease
- Chronic migraine, i.e. more than 15 headache days per month over the last three months
- Medication overuse headache
- More than six migraine-with-aura attacks per month
- Non-migraine headache on more than six days per month
- A typical duration between migraine-with-aura attacks of less than 48 hours
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Aarhus University Hospitalcollaborator
- Rehalercollaborator
Study Sites (1)
Pain and Headache Clinic, Aarhus University Hospital
Aarhus, 8000, Denmark
Related Publications (1)
Fuglsang CH, Johansen T, Kaila K, Kasch H, Bach FW. Treatment of acute migraine by a partial rebreathing device: A randomized controlled pilot study. Cephalalgia. 2018 Sep;38(10):1632-1643. doi: 10.1177/0333102418797285. Epub 2018 Aug 22.
PMID: 30134739DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Flemming W Bach, MD, PhD
Aarhus University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2017
First Posted
March 21, 2018
Study Start
November 1, 2016
Primary Completion
September 1, 2017
Study Completion
September 1, 2017
Last Updated
March 23, 2018
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will not share