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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2021-10-30

Brief Summary

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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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Detailed Description

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Conditions

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Headache, Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Adenosine

Group Type ACTIVE_COMPARATOR

Adenosine

Intervention Type DRUG

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

Saline

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

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

Interventions

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Adenosine

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

Intervention Type DRUG

Saline

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes