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

Not Applicable

Completed

• Conditions: Headache, Migraine
• Interventions: Drug: Saline; Drug: Adenosine

• Registration Number: NCT04577443
• Lead Sponsor: Danish Headache Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-30
• Study First Submitted QC: 2020-09-30
• Study First Posted: 2020-10-08
• Study Start: 2020-11-01
• Primary Completion: 2021-10-30
• Study Completion: 2021-10-30
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-15
• Last Update Posted: 2022-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Saline	Saline	-
Adenosine	Adenosine	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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)

Trial Locations

Locations (1)

Rigshospitalet-Glostrup; 🇩🇰 Glostrup, Nordre Ringvej 57, Denmark