Clinical trial NCT04577443: The Effect of Adenosine on Cranial Hemodynamic, Headache and Migraine Induction Properties.
Official title: To Investigate the Headache Induction and the Cerebral Hemodynamic Changes After Infusion of Adenosine in Healthy Volunteers and Migraine Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache, Migraine
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Occurrence and change of migraine attack
timeFrame: Before (-10 minutes) and after infusion (+12 hours) of adenosine compared with before and after infusion of saline
Secondary outcomes:
measure: Change in cerebral hemodynamic
timeFrame: Before (-10 minutes) and after infusion (+12 hours) of adenosine compared with before and after infusion of saline
measure: Occurrence and change of headache
timeFrame: Before (-10 minutes) and after infusion (+12 hours) of adenosine compared with before and after infusion of saline
measure: Change of diameter of the artery
timeFrame: Before (-10 minutes) and after infusion (+12 hours) of adenosine compared with before and after infusion of saline
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Rigshospitalet-Glostrup
state: Nordre Ringvej 57
Study officials:
affiliation: Danish Headache Center
name: Messoud Ashina
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thuraiaiyah J, Al-Karagholi MA, Elbahi FA, Zhuang ZA, Ashina M. Adenosine causes short-lasting vasodilation and headache but not migraine attacks in migraine patients: a randomized clinical trial. Pain. 2023 May 1;164(5):1118-1127. doi: 10.1097/j.pain.0000000000002804. Epub 2022 Oct 17.