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Completed

NCT Number: NCT04577443

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

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.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet-Glostrup

Glostrup Municipality, Nordre Ringvej 57, 2600, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adenosine

Drug

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

Saline

Drug

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

Primary outcomes

  1. Occurrence and change of migraine attack

    Time frame: 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 outcomes

  1. Change in cerebral hemodynamic

    Time frame: 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.

  2. Occurrence and change of headache

    Time frame: 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)

  3. Change of diameter of the artery

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Danish Headache Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 8, 2020
Registry last updated
Nov 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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