The Effect of Adenosine on Cranial Hemodynamic, Headache and Migraine Induction Properties.

Study Overview
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Brief Summary
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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.

Official Title
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To Investigate the Headache Induction and the Cerebral Hemodynamic Changes After Infusion of Adenosine in Healthy Volunteers and Migraine Patient

Conditions
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Headache, Migraine

Intervention / Treatment
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* Drug: Adenosine
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Adenosine<br> | Drug: Adenosine<br>* To investigate the role of adenosine on cerebral hemodynamic and headache in healthy volunteers and migraine patients<br>|
| Placebo Comparator: Saline<br> | Drug: Saline<br>* To investigate the role of saline on cerebral hemodynamic and headache in healthy volunteers and migraine patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence and change of migraine attack | Occurrence and of migraine according to international criteria | Before (-10 minutes) and after infusion (+12 hours) of adenosine compared with before and after infusion of saline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cerebral hemodynamic | Change on velocity of media cerebri artery. | Before (-10 minutes) and after infusion (+12 hours) of adenosine compared with before and after infusion of saline | 
| Occurrence and change of headache | Occurrence of headache measured by numerical rating scale (NRS) | Before (-10 minutes) and after infusion (+12 hours) of adenosine compared with before and after infusion of saline | 
| Change of diameter of the artery | Change of diameter of superficial temporal artery and radial artery. The diameter will be measured by millimeter (mm). | Before (-10 minutes) and after infusion (+12 hours) of adenosine compared with before and after infusion of saline |