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

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ClinicalTrials.gov Identifier: NCT04577443
Recruitment Status : Recruiting
First Posted : October 8, 2020
Last Update Posted : December 10, 2020
Sponsor:
Information provided by (Responsible Party):
Mohammad Al-Mahdi Al-Karagholi, Danish Headache Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Headache, Migraine Drug: Adenosine Drug: Saline Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: To Investigate the Headache Induction and the Cerebral Hemodynamic Changes After Infusion of Adenosine in Healthy Volunteers and Migraine Patient
Actual Study Start Date : November 1, 2020
Estimated Primary Completion Date : October 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache Migraine
Drug Information available for: Adenosine

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Adenosine Drug: Adenosine
To investigate the role of adenosine on cerebral hemodynamic and headache in healthy volunteers and migraine patients
Placebo Comparator: Saline Drug: Saline
To investigate the role of saline on cerebral hemodynamic and headache in healthy volunteers and migraine patients


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04577443


Contacts
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Contact: Mohammad Al-Karagholi 31191647 mahdi.alkaragholi@gmail.com

Locations
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Denmark
Rigshospitalet-Glostrup Recruiting
Glostrup, Nordre Ringvej 57, Denmark, 2600
Contact: Mohammad A Al-Karagholi, MD    00 45 31 19 16 47    mahdi.alkaragholi@gmail.com   
Contact: Song Guo, MD, PhD         
Sponsors and Collaborators
Danish Headache Center
Investigators
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Principal Investigator: Messoud Ashina Danish Headache Center
More Information
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Responsible Party: Mohammad Al-Mahdi Al-Karagholi, Principal investigator, Danish Headache Center
ClinicalTrials.gov Identifier: NCT04577443    
Other Study ID Numbers: Adenosine H-20027630
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: December 10, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Adenosine
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action