Clinical trial NCT03472417: Partial Rebreathing in the Treatment of Migraine With Aura
Official title: Partial Rebreathing in the Treatment of Migraine With Aura
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine With Aura
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Rehaler
First posted: 2018-03-21
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A study to test the efficacy of a partial rebreathing device in treating and/or preventing migraine pain


Eligibility criteria: Inclusion Criteria:

* - 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

Exclusion Criteria:

* - 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

Primary outcomes:
measure: Headache Intensity Difference at 0 vs 2 hours post-treatment
timeFrame: 2 hours
Secondary outcomes:
measure: Headache Intensity Difference at 0 and 1 hour post-treatment (0-3 point scale)
timeFrame: 1 hour
measure: Pain reduction/relief at 1 hour
timeFrame: 1 hour
measure: Pain reduction/relief at 2 hours
timeFrame: 2 hours
measure: Nausea Intensity Difference 0 vs 1 hour post-treatment
timeFrame: 1 hour
measure: Nausea Intensity Difference 0 vs 2 hours post-treatment
timeFrame: 2 hours
measure: Photo - and/or phono-phobia Intensity Difference 0 vs 1 hour post-treatment
timeFrame: 1 hour
measure: Photo - and/or phono-phobia Intensity Difference 0 vs 2 hours post-treatment
timeFrame: 2 hours
measure: Functional Disability Difference 0 vs 1 hour post-treatment
timeFrame: 1 hour
measure: Functional Disability Difference 0 vs 2 hours post-treatment
timeFrame: 2 hours
measure: Sustained pain freedom at 24 hours
timeFrame: 24 hours
measure: Treatment preference vs. patient's normal treatment
timeFrame: 24 hours
measure: Aura symptoms aborted after one use of device
timeFrame: 20 minutes
measure: Side effects
timeFrame: through study completion (1 to 10 months)
measure: Adverse events
timeFrame: through study completion (1 to 10 months)
measure: Medicine use in 24 hours after device use
timeFrame: 24 hours
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Pain and Headache Clinic, Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Flemming W Bach, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.