Headache, Migraine
Conditions
Brief summary
Adenosine is a nucleoside that plays a role in both vascular and nociceptive systems, and it has been proposed that adenosine may cause headache in particularly sensitive subjects. Thus, considerable evidence implied that adenosine plays a role in migraine pathophysiology, it is still unknown if intravenous adenosine infusion provokes migraine attacks in healthy subject or in migraine patients. Furthermore, adenosine's effects on the cerebral hemodynamic remains unknown. This study aims to clarify a possible coherence between adenosine and headache/migraine. In general, the study will contribute to a greater understanding of migraine pathogenesis and possibly lead to development of specific migraine treatment.
Interventions
DRUGAdenosine
To investigate the role of adenosine on cerebral hemodynamic and headache in healthy volunteers and migraine patients
DRUGSaline
To investigate the role of saline on cerebral hemodynamic and headache in healthy volunteers and migraine patients
Sponsors
Danish Headache Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Migraine patients without aura who fulfill criteria in the international classification of headaches. This does not apply to healthy volunteers. * 18-60 years. * 50-90 kg. * Women of childbearing potential must use adequate contraception
Exclusion criteria
* Headache less than 48 hours before the tests start * All primary headaches, except migraine without aura for migraine patients, according to international classification of headache * Daily consumption of drugs of any kind other than oral contraceptives * Pregnant or nursing women. * Cardiovascular disease of any kind, including cerebrovascular diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence and change of migraine attack | Before (-10 minutes) and after infusion (+12 hours) of adenosine compared with before and after infusion of saline | Occurrence and of migraine according to international criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in cerebral hemodynamic | Before (-10 minutes) and after infusion (+12 hours) of adenosine compared with before and after infusion of saline | Change on velocity of media cerebri artery. |
| Occurrence and change of headache | Before (-10 minutes) and after infusion (+12 hours) of adenosine compared with before and after infusion of saline | Occurrence of headache measured by numerical rating scale (NRS) |
| Change of diameter of the artery | Before (-10 minutes) and after infusion (+12 hours) of adenosine compared with before and after infusion of saline | Change of diameter of superficial temporal artery and radial artery. The diameter will be measured by millimeter (mm). |
Countries
Denmark
Outcome results
None listed