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

Primary Purpose

Headache, Migraine

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Adenosine
Saline
Sponsored by
Danish Headache Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Headache, Migraine

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts 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.

Sites / Locations

  • Rigshospitalet-Glostrup

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Adenosine

Saline

Arm Description

Outcomes

Primary Outcome Measures

Occurrence and change of migraine attack
Occurrence and of migraine according to international criteria

Secondary Outcome Measures

Change in cerebral hemodynamic
Change on velocity of media cerebri artery.
Occurrence and change of headache
Occurrence of headache measured by numerical rating scale (NRS)
Change of diameter of the artery
Change of diameter of superficial temporal artery and radial artery. The diameter will be measured by millimeter (mm).

Full Information

First Posted
September 30, 2020
Last Updated
November 15, 2022
Sponsor
Danish Headache Center
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1. Study Identification

Unique Protocol Identification Number
NCT04577443
Brief Title
The Effect of Adenosine on Cranial Hemodynamic, Headache and Migraine Induction Properties.
Official Title
To Investigate the Headache Induction and the Cerebral Hemodynamic Changes After Infusion of Adenosine in Healthy Volunteers and Migraine Patient
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
October 30, 2021 (Actual)
Study Completion Date
October 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Headache Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache, Migraine

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adenosine
Arm Type
Active Comparator
Arm Title
Saline
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Adenosine
Intervention Description
To investigate the role of adenosine on cerebral hemodynamic and headache in healthy volunteers and migraine patients
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
To investigate the role of saline on cerebral hemodynamic and headache in healthy volunteers and migraine patients
Primary Outcome Measure Information:
Title
Occurrence and change of migraine attack
Description
Occurrence and of migraine according to international criteria
Time Frame
Before (-10 minutes) and after infusion (+12 hours) of adenosine compared with before and after infusion of saline
Secondary Outcome Measure Information:
Title
Change in cerebral hemodynamic
Description
Change on velocity of media cerebri artery.
Time Frame
Before (-10 minutes) and after infusion (+12 hours) of adenosine compared with before and after infusion of saline
Title
Occurrence and change of headache
Description
Occurrence of headache measured by numerical rating scale (NRS)
Time Frame
Before (-10 minutes) and after infusion (+12 hours) of adenosine compared with before and after infusion of saline
Title
Change of diameter of the artery
Description
Change of diameter of superficial temporal artery and radial artery. The diameter will be measured by millimeter (mm).
Time Frame
Before (-10 minutes) and after infusion (+12 hours) of adenosine compared with before and after infusion of saline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Messoud Ashina
Organizational Affiliation
Danish Headache Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet-Glostrup
City
Glostrup
State/Province
Nordre Ringvej 57
ZIP/Postal Code
2600
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36251971
Citation
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.
Results Reference
derived

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

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