Migraine With Aura Clinical Trial
— CapnoMigraOfficial title:
Partial Rebreathing in the Treatment of Migraine With Aura
Verified date | November 2016 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A study to test the efficacy of a partial rebreathing device in treating and/or preventing migraine pain
Status | Completed |
Enrollment | 18 |
Est. completion date | September 2017 |
Est. primary completion date | September 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Pain and Headache Clinic, Aarhus University Hospital | Aarhus |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus | Aarhus University Hospital, BalancAir |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Headache Intensity Difference at 0 and 1 hour post-treatment (0-3 point scale) | 0-3 point scale (0 = none, 1 = mild, 2= moderate, 3 =severe) | 1 hour | |
Secondary | Pain reduction/relief at 1 hour | percentage of study participants reporting no or mild pain 1 hour after first using the device | 1 hour | |
Secondary | Pain reduction/relief at 2 hours | percentage of study participants reporting no or mild pain 2 hours after first using the device | 2 hours | |
Secondary | Nausea Intensity Difference 0 vs 1 hour post-treatment | 0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe) | 1 hour | |
Secondary | Nausea Intensity Difference 0 vs 2 hours post-treatment | 0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe) | 2 hours | |
Secondary | Photo - and/or phono-phobia Intensity Difference 0 vs 1 hour post-treatment | 0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe) | 1 hour | |
Secondary | Photo - and/or phono-phobia Intensity Difference 0 vs 2 hours post-treatment | 0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe) | 2 hours | |
Secondary | Functional Disability Difference 0 vs 1 hour post-treatment | 0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe) | 1 hour | |
Secondary | Functional Disability Difference 0 vs 2 hours post-treatment | 0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe) | 2 hours | |
Secondary | Sustained pain freedom at 24 hours | percentage of study participants who are pain free 24 hours after device use | 24 hours | |
Secondary | Treatment preference vs. patient's normal treatment | -2 to +2 scale ((-2 = much worse than normal treatment, - 1 = somewhat worse, 0 = no difference, +1 = somewhat better, +2 = much better)) | 24 hours | |
Secondary | Aura symptoms aborted after one use of device | yes/no | 20 minutes | |
Secondary | Side effects | Qualitative analysis | through study completion (1 to 10 months) | |
Secondary | Adverse events | Qualitative analysis | through study completion (1 to 10 months) | |
Secondary | Medicine use in 24 hours after device use | qualitative comparison | 24 hours |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02253004 -
Induction of Migraine Aura With Cilostazol
|
Phase 0 | |
Recruiting |
NCT02202486 -
Investigation of the Blood-brain and Blood-dura Barrier Durin Migraine Attacks Using MRI
|
N/A | |
Completed |
NCT00123201 -
Study to Evaluate the Efficacy and Safety of Dronabinol Metered Dose Inhaler (MDI) in Acute Treatment of Migraine Headache
|
Phase 2 | |
Completed |
NCT04406649 -
A Study to Evaluate the Safety of STS101 in the Acute Treatment of Migraine
|
Phase 3 | |
Completed |
NCT03874832 -
A Phase I Study to Study the PK and Safety of Single Doses of STS101, DHE Injection and Nasal Spray in Healthy Subjects
|
Phase 1 | |
Recruiting |
NCT05565001 -
The Involvement of ATP Sensitive Potassium Channel in Migraine Aura and Migraine Pain.
|
N/A | |
Recruiting |
NCT06459635 -
Migraine Attack Pain Phase Prediction Study
|
||
Recruiting |
NCT05416476 -
Anisodine Hydrobromide For The Preventive Treatment Of Episodic Migraine
|
Phase 3 | |
Active, not recruiting |
NCT02906085 -
Endothelin-1 as a Potential Trigger of Migraine Aura
|
N/A | |
Recruiting |
NCT00893594 -
Efficacy of Sumatriptan With Naprosyn in Migraine With Aura
|
N/A | |
Completed |
NCT01388699 -
Migraine and Endothelial Dysfunction
|
||
Completed |
NCT00534560 -
Dose Ranging Study of the Efficacy and Tolerability of Tonabersat in the Prophylaxis of Migraine Headache
|
Phase 2 | |
Terminated |
NCT04936061 -
Transnasal Cooling for Migraine
|
N/A | |
Recruiting |
NCT05281770 -
Monoclonal CGRP Antibodies for Migraine Prevention - a Nationwide Real Life Study
|
||
Not yet recruiting |
NCT04063540 -
Acid-Sensing Ion Channel and Migraine Disease Proof of Concept Study on the Efficacy of Amiloride in the Prophylaxis of Migraine Aura
|
Phase 2 | |
Completed |
NCT00334178 -
Evaluation of the Efficacy and Safety of Laxymig® as Prophylactic Treatment in Patients With Migraine
|
Phase 3 | |
Recruiting |
NCT06051604 -
Mi-Helper Transnasal Cooling for Acute Treatment of Migraine
|
N/A | |
Recruiting |
NCT06414044 -
Italian Real-life obServational Study on the effecTiveness, sAfety and Tolerability of Atogepant in Migraine Patients
|
||
Completed |
NCT03472378 -
Can DFN-15 Terminate Migraine With Allodynia?
|
Phase 2 | |
Recruiting |
NCT05211154 -
Evaluation of the Efficacy of Diclofenac Potassium and Rimegepant for the Acute Treatment of Migraine
|
Phase 4 |