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

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

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.

Study Overview

• Status: Completed
• Conditions: Headache, Migraine
• Intervention / Treatment: Drug: Saline; Drug: Adenosine

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Nordre Ringvej 57
    • Glostrup, Nordre Ringvej 57, Denmark, 2600
      • Rigshospitalet-Glostrup

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Danish Headache Center
• Investigators: Principal Investigator: Messoud Ashina, Danish Headache Center

Publications and helpful links

General Publications

• 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. 2022 Oct 17. doi: 10.1097/j.pain.0000000000002804. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): October 30, 2021
• Study Completion (Actual): October 30, 2021

Study Registration Dates

• First Submitted: September 30, 2020
• First Submitted That Met QC Criteria: September 30, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Actual): November 16, 2022
• Last Update Submitted That Met QC Criteria: November 15, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Vasodilator Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Purinergic Agents; Purinergic P1 Receptor Agonists; Purinergic Agonists; Adenosine
• Other Study ID Numbers: Adenosine H-20027630

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No