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

Headache, Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04577443
• Other study ID #: Adenosine H-20027630
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: October 30, 2021

Study information

• Verified date: November 2022
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 30, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Headache, Migraine
• Migraine Disorders

Intervention

Drug:
• Adenosine
To investigate the role of adenosine on cerebral hemodynamic and headache in healthy volunteers and migraine patients
• Saline
To investigate the role of saline on cerebral hemodynamic and headache in healthy volunteers and migraine patients

Locations

Country	Name	City	State
Denmark	Rigshospitalet-Glostrup	Glostrup	Nordre Ringvej 57

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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