Headache, MigraineNCT04577443
The Effect of Adenosine on Cranial Hemodynamic, Headache and Migraine Induction Properties.
A study testing Adenosine and Saline in people with Headache, Migraine, run by Danish Headache Center at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Headache, Migraine
- What is being tested?
- Adenosine and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2020to 30 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Denmark1 site
Rigshospitalet-Glostrup
Glostrup Municipality, Nordre Ringvej 57, 2600
About this study
Official title: To Investigate the Headache Induction and the Cerebral Hemodynamic Changes After Infusion of Adenosine in Healthy Volunteers and Migraine Patient
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.
- Conditions
- Headache, Migraine
- Being tested
- Adenosine, Saline
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdenosineDrug
To investigate the role of adenosine on cerebral hemodynamic and headache in healthy volunteers and migraine patients
SalineDrug
To investigate the role of saline on cerebral hemodynamic and headache in healthy volunteers and migraine patients
| Study group | Role | What they receive |
|---|---|---|
| Adenosine | Active comparator | Not described Receives: Drug: Adenosine |
| Saline | Placebo comparator | Not described Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence and change of migraine attack
Occurrence and of migraine according to international criteria
Measured: Before (-10 minutes) and after infusion (+12 hours) of adenosine compared with before and after infusion of saline
Secondary outcomes (3)
Change in cerebral hemodynamic
Change on velocity of media cerebri artery.
Measured: Before (-10 minutes) and after infusion (+12 hours) of adenosine compared with before and after infusion of saline
Occurrence and change of headache
Occurrence of headache measured by numerical rating scale (NRS)
Measured: Before (-10 minutes) and after infusion (+12 hours) of adenosine compared with before and after infusion of saline
Change of diameter of the artery
Change of diameter of superficial temporal artery and radial artery. The diameter will be measured by millimeter (mm).
Measured: Before (-10 minutes) and after infusion (+12 hours) of adenosine compared with before and after infusion of saline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start1 Nov 2020
- Primary completion30 Oct 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Headache, MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Al-Mahdi Al-Karagholi, Danish Headache Center
- Investigators
- Messoud Ashina, Principal investigator, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04577443
- Sponsor's protocol ID
- Adenosine H-20027630
- Status last verified
- Nov 2022
- First submitted
- 30 Sep 2020
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36251971
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Investigate the Headache Induction and the Cerebral Hemodynamic Changes After Infusion of Adenosine in Healthy Volunteers and Migraine Patient
- ClinicalTrials.gov ID
- NCT04577443
- Acronym / sponsor ID
- Adenosine H-20027630
- Conditions
- Headache, Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adenosine | Active comparator | Drug: Adenosine |
| Saline | Placebo comparator | Drug: Saline |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdenosineTo investigate the role of adenosine on cerebral hemodynamic and headache in healthy volunteers and migraine patients | Drug | Adenosine |
| SalineTo investigate the role of saline on cerebral hemodynamic and headache in healthy volunteers and migraine patients | Drug | Saline |
Primary outcome
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
3 secondary outcomes
Change in cerebral hemodynamic
Time frame: Before (-10 minutes) and after infusion (+12 hours) of adenosine compared with before and after infusion of saline
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- Derived from this study: PubMed 36251971Thuraiaiyah 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Messoud Ashina principal investigator
Danish Headache Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adenosine and Saline in people with Headache, Migraine, run by Danish Headache Center at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04577443, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2022; AzTrials last refreshed its copy on 7 Nov 2026.