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

NCT04577443 | Completed

• 1 other identifier: Adenosine H-20027630
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Headache, Migraine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in cerebral hemodynamic

  Before (-10 minutes) and after infusion (+12 hours) of adenosine compared with before and after infusion of saline

• Occurrence and change of headache

  Before (-10 minutes) and after infusion (+12 hours) of adenosine compared with before and after infusion of saline

• Change of diameter of the artery

  Before (-10 minutes) and after infusion (+12 hours) of adenosine compared with before and after infusion of saline

Study Arms (2)

Adenosine

ACTIVE COMPARATOR

Drug: Adenosine

Saline

PLACEBO COMPARATOR

Drug: Saline

Interventions

Adenosine DRUG

To investigate the role of adenosine on cerebral hemodynamic and headache in healthy volunteers and migraine patients

Adenosine

Saline DRUG

To investigate the role of saline on cerebral hemodynamic and headache in healthy volunteers and migraine patients

Saline

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Migraine patients without aura who fulfill criteria in the international classification of headaches. This does not apply to healthy volunteers.
• years.
• kg.
• Women of childbearing potential must use adequate contraception

You may not qualify if:

• 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.

Sponsors & Collaborators

• Danish Headache Center: lead

Study Sites (1)

Rigshospitalet-Glostrup

Glostrup Municipality, Nordre Ringvej 57, 2600, Denmark

Location

Related Publications (1)

• 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.

  PMID: 36251971 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

Adenosine; Sodium Chloride

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Messoud Ashina

  Danish Headache Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 8, 2020
• Study Start: November 1, 2020
• Primary Completion: October 30, 2021
• Study Completion: October 30, 2021
• Last Updated: November 16, 2022

Record last verified: 2022-11

Locations

DK (1)