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

D

Danish Headache Center

Status

Completed

Conditions

Headache, Migraine

Treatments

Drug: Adenosine
Drug: Saline

Study type

Interventional

Funder types

Other

Identifiers

NCT04577443
Adenosine H-20027630

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

18 participants in 2 patient groups, including a placebo group

Adenosine
Active Comparator group
Treatment:
Drug: Adenosine
Saline
Placebo Comparator group
Treatment:
Drug: Saline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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