MigraineNCT07451769
Selective Activation of the Adrenomedullin Receptors in Migraine
A study testing Adrenomedullin in people with Migraine and Brain Diseases, run by Danish Headache Center at 1 site in Denmark.
Trial summary
Adrenomedullin is a neuropeptide implicated in the pathogenesis of migraine. This study investigates whether its administration, after pre-treatment with erenumab (a CGRP-receptor blocking monoclonal antibody), can trigger migraine attacks in individuals with migraine without aura. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine, Brain Diseases, Central Nervous System Diseases
- What is being tested?
- Adrenomedullin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Mar 2026to 20 Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent has been obtained prior to the initiation of any study-specific procedures.
- Age ≥18 years at the time of screening.
- History of migraine without aura for at least 12 months prior to screening, with a frequency of 1-5 migraine attacks per month, based on medical records and/or patient self-report, and diagnosed in accordance with the ICHD-3 criteria.
Who cannot join
- History of any other primary headache disorder, except for tension-type headache with <5 headache days per month, based on ICHD-3 classification.
- History of any secondary headache disorder, per ICHD-3 criteria, prior to screening.
- Use of prophylactic migraine medication within 30 days or within 5 plasma half-lives (whichever is longer) prior to screening.
- Previous use of any therapies targeting the CGRP signaling pathway, including anti-CGRP ligand monoclonal antibodies, anti-CGRP receptor monoclonal antibodies, or small molecule CGRP receptor antagonists.
- Known risk of self-harm or harm to others, including a history of suicidal behavior.
- Any clinically significant disorder, condition, or disease (other than those permitted in the protocol) that, in the opinion of the investigator, could compromise participant safety or interfere with study procedures or data integrity.
Show all 10Show fewer
- Positive urine pregnancy test at screening or on Day 1 in female participants of childbearing potential.
- Pregnancy or breastfeeding, or plans to become pregnant or breastfeed during the study period.
- Evidence of current pregnancy or breastfeeding based on self-report or medical records.
- Inability or unwillingness to complete all protocol-required visits and procedures, or concerns regarding protocol adherence, as judged by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Danish Headache Center
Glostrup Municipality, 2600
Hakan Ashina, MD, Ph.D, Ass. Professor, +4528102495, haakan.ashina@regionh.dk
Annette Maria Ellekaer Fuchs, MD, +4526232421, annette.maria.ellekaer.fuchs@regionh.dk
About this study
Official title: Selective Activation of the Adrenomedullin Receptors in Migraine: A Randomized, Double-Blind, Placebo-Controlled Crossover Study
Adrenomedullin is a neuropeptide implicated in the pathogenesis of migraine. This study investigates whether its administration, after pre-treatment with erenumab (a CGRP-receptor blocking monoclonal antibody), can trigger migraine attacks in individuals with migraine without aura.
Read the detailed description
Adrenomedullin is an endogenous neuropeptide structurally related to CGRP that can activate both the adrenomedullin receptor and, to a lesser extent, the CGRP receptor. Prior human provocation studies have shown that administration of adrenomedullin can elicit migraine attacks in people with migraine. Because adrenomedullin lacks receptor selectivity, physiological responses observed after its administration might represent a composite of adrenomedullin-receptor activation and potential off-target activation of the CGRP receptor. The extent to which selective activation of the adrenomedullin receptor alone can provoke migraine-relevant responses remains unknown.
To isolate adrenomedullin receptor-mediated effects, participants will receive the monoclonal antibody erenumab prior to adrenomedullin administration in order to block CGRP receptor activation.
This study therefore aims to determine whether selective activation of adrenomedullin receptors - isolated from confounding CGRP receptor activation - can induce migraine-relevant physiological responses.
- Conditions
- Migraine, Brain Diseases, Central Nervous System Diseases, Adrenomedullin, Pain, Peptides
- Being tested
- Adrenomedullin, Placebo
- Keywords
- Migraine Disorders, Adrenomedulin, Pain
- Medical subject headings
- Migraine Disorders, Brain Diseases, Central Nervous System Diseases, Pain, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdrenomedullinDrug
Continous intravenous infusion of 20 mL (19.9 pmol/kg/min) adrenomedulin over 20 minutes
PlaceboOther
Continous intravenous infusion of 20 mL isotonic saline over 20 minutes
| Study group | Role | What they receive |
|---|---|---|
| Adrenomedullin | Experimental | Not described Receives: Drug: Adrenomedullin |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of migraine attacks
Incidence of migraine attacks, defined by either:
- Headache fulfilling criteria C and D for migraine without aura according to ICHD-3 2
- Criterion C: At least two of the following:
- Unilateral location
- Pulsating quality
- Moderate to severe pain intensity (≥4 on an 11-point numerical rating scale)
- Aggravation by cough (in-hospital setting) or avoidance of routine physical activity (out-hospital setting)
- Criterion D: At least one of the following:
- Nausea and/or vomiting
- Photophobia and phonophobia OR II. Headache that mimics the participant's usual spontaneous migraine attacks and is treated with acute migraine (rescue) medication.
Measured: Assessed from baseline to 12 hours post-infusion of adrenomedullin or placebo
Secondary outcomes (1)
Headache intensity
Headache intensity, assessed using a numerical rating scale (NRS) from 0 to 10:
- 0 = No headache
- 10 = Worst headache imaginable
Measured: Assessed from baseline to 12 hours post-infusion of adrenomedullin or placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start12 Mar 2026
- Primary completion10 Mar 2027 (estimated)
- Study completion20 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This single-center trial applies a randomized, double-blind, placebo-controlled, two-way crossover design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Håkan Ashina, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07451769
- Sponsor's protocol ID
- 118122
- Status last verified
- Jan 2026
- First submitted
- 28 Feb 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data not published within this article will be made available on reasonable request from any qualified investigator
Publications
Do TP, Younis S, Ashina M. Erenumab [Internet]. 2021. p. 121-9.Available from: https://link.springer.com/10.1007/978-3-030-69032-8_9
Goadsby PJ, Reuter U, Hallstrom Y, Broessner G, Bonner JH, Zhang F, Sapra S, Picard H, Mikol DD, Lenz RA. A Controlled Trial of Erenumab for Episodic Migraine. N Engl J Med. 2017 Nov 30;377(22):2123-2132. doi: 10.1056/NEJMoa1705848.
PubMed 29171821de Hoon J, Van Hecken A, Vandermeulen C, Yan L, Smith B, Chen JS, Bautista E, Hamilton L, Waksman J, Vu T, Vargas G. Phase I, Randomized, Double-blind, Placebo-controlled, Single-dose, and Multiple-dose Studies of Erenumab in Healthy Subjects and Patients With Migraine. Clin Pharmacol Ther. 2018 May;103(5):815-825. doi: 10.1002/cpt.799. Epub 2017 Oct 24.
PubMed 28736918Giamberardino MA, Affaitati G, Costantini R, Cipollone F, Martelletti P. Calcitonin gene-related peptide receptor as a novel target for the management of people with episodic migraine: current evidence and safety profile of erenumab. J Pain Res. 2017 Dec 8;10:2751-2760. doi: 10.2147/JPR.S128143. eCollection 2017.
PubMed 29263689Meeran K, O'Shea D, Upton PD, Small CJ, Ghatei MA, Byfield PH, Bloom SR. Circulating adrenomedullin does not regulate systemic blood pressure but increases plasma prolactin after intravenous infusion in humans: a pharmacokinetic study. J Clin Endocrinol Metab. 1997 Jan;82(1):95-100. doi: 10.1210/jcem.82.1.3656.
PubMed 8989240Ashina M, Hansen JM, A Dunga BO, Olesen J. Human models of migraine - short-term pain for long-term gain. Nat Rev Neurol. 2017 Dec;13(12):713-724. doi: 10.1038/nrneurol.2017.137. Epub 2017 Oct 6.
PubMed 28984313Hay DL, Garelja ML, Poyner DR, Walker CS. Update on the pharmacology of calcitonin/CGRP family of peptides: IUPHAR Review 25. Br J Pharmacol. 2018 Jan;175(1):3-17. doi: 10.1111/bph.14075. Epub 2017 Nov 28.
PubMed 29059473Ghanizada H, Al-Karagholi MA, Arngrim N, Morch-Rasmussen M, Walker CS, Hay DL, Ashina M. Effect of Adrenomedullin on Migraine-Like Attacks in Patients With Migraine: A Randomized Crossover Study. Neurology. 2021 May 18;96(20):e2488-e2499. doi: 10.1212/WNL.0000000000011930. Epub 2021 Apr 7.
PubMed 33827963Shi L, Lehto SG, Zhu DX, Sun H, Zhang J, Smith BP, Immke DC, Wild KD, Xu C. Pharmacologic Characterization of AMG 334, a Potent and Selective Human Monoclonal Antibody against the Calcitonin Gene-Related Peptide Receptor. J Pharmacol Exp Ther. 2016 Jan;356(1):223-31. doi: 10.1124/jpet.115.227793. Epub 2015 Nov 11.
PubMed 26559125Lipton RB, Bigal ME, Diamond M, Freitag F, Reed ML, Stewart WF; AMPP Advisory Group. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2007 Jan 30;68(5):343-9. doi: 10.1212/01.wnl.0000252808.97649.21.
PubMed 17261680Steiner TJ, Jensen R, Katsarava Z, Linde M, MacGregor EA, Osipova V, Paemeleire K, Olesen J, Peters M, Martelletti P. Aids to management of headache disorders in primary care (2nd edition) : on behalf of the European Headache Federation and Lifting The Burden: the Global Campaign against Headache. J Headache Pain. 2019 May 21;20(1):57. doi: 10.1186/s10194-018-0899-2.
PubMed 31113373Stovner LJ, Andree C. Prevalence of headache in Europe: a review for the Eurolight project. J Headache Pain. 2010 Aug;11(4):289-99. doi: 10.1007/s10194-010-0217-0. Epub 2010 May 16.
PubMed 20473702Robbins MS, Lipton RB. The epidemiology of primary headache disorders. Semin Neurol. 2010 Apr;30(2):107-19. doi: 10.1055/s-0030-1249220. Epub 2010 Mar 29.
PubMed 20352581Ashina M, Terwindt GM, Al-Karagholi MA, de Boer I, Lee MJ, Hay DL, Schulte LH, Hadjikhani N, Sinclair AJ, Ashina H, Schwedt TJ, Goadsby PJ. Migraine: disease characterisation, biomarkers, and precision medicine. Lancet. 2021 Apr 17;397(10283):1496-1504. doi: 10.1016/S0140-6736(20)32162-0. Epub 2021 Mar 25.
PubMed 33773610Ashina M. Migraine. N Engl J Med. 2020 Nov 5;383(19):1866-1876. doi: 10.1056/NEJMra1915327. No abstract available.
PubMed 33211930
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Activation of the Adrenomedullin Receptors in Migraine: A Randomized, Double-Blind, Placebo-Controlled Crossover Study
- ClinicalTrials.gov ID
- NCT07451769
- Acronym / sponsor ID
- 118122
- Conditions
- Migraine, Brain Diseases, Central Nervous System Diseases, Adrenomedullin, Pain, Peptides
- Keywords
- Migraine Disorders, Adrenomedulin, Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- 12 Mar 2026 (actual)
- Primary completion
- 10 Mar 2027 (estimated)
- Study completion
- 20 Dec 2032 (estimated)
- First posted
- 5 Mar 2026 (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.
Adrenomedullin is a neuropeptide implicated in the pathogenesis of migraine. This study investigates whether its administration, after pre-treatment with erenumab (a CGRP-receptor blocking monoclonal antibody), can trigger migraine attacks in individuals with migraine without aura.
Detailed description
Adrenomedullin is an endogenous neuropeptide structurally related to CGRP that can activate both the adrenomedullin receptor and, to a lesser extent, the CGRP receptor. Prior human provocation studies have shown that administration of adrenomedullin can elicit migraine attacks in people with migraine. Because adrenomedullin lacks receptor selectivity, physiological responses observed after its administration might represent a composite of adrenomedullin-receptor activation and potential off-target activation of the CGRP receptor. The extent to which selective activation of the adrenomedullin receptor alone can provoke migraine-relevant responses remains unknown.
To isolate adrenomedullin receptor-mediated effects, participants will receive the monoclonal antibody erenumab prior to adrenomedullin administration in order to block CGRP receptor activation.
This study therefore aims to determine whether selective activation of adrenomedullin receptors - isolated from confounding CGRP receptor activation - can induce migraine-relevant physiological responses.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This single-center trial applies a randomized, double-blind, placebo-controlled, two-way crossover design
| Arm | Type | Receives |
|---|---|---|
| Adrenomedullin | Experimental | Drug: Adrenomedullin |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent has been obtained prior to the initiation of any study-specific procedures.
- Age ≥18 years at the time of screening.
- History of migraine without aura for at least 12 months prior to screening, with a frequency of 1-5 migraine attacks per month, based on medical records and/or patient self-report, and diagnosed in accordance with the ICHD-3 criteria.
Key exclusion criteria (10 listed)
- History of any other primary headache disorder, except for tension-type headache with <5 headache days per month, based on ICHD-3 classification.
- History of any secondary headache disorder, per ICHD-3 criteria, prior to screening.
- Use of prophylactic migraine medication within 30 days or within 5 plasma half-lives (whichever is longer) prior to screening.
- Previous use of any therapies targeting the CGRP signaling pathway, including anti-CGRP ligand monoclonal antibodies, anti-CGRP receptor monoclonal antibodies, or small molecule CGRP receptor antagonists.
- Known risk of self-harm or harm to others, including a history of suicidal behavior.
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 |
|---|---|---|
| AdrenomedullinContinous intravenous infusion of 20 mL (19.9 pmol/kg/min) adrenomedulin over 20 minutes | Drug | Adrenomedullin |
| PlaceboContinous intravenous infusion of 20 mL isotonic saline over 20 minutes | Other | Placebo |
Primary outcome
Incidence of migraine attacks
Time frame: Assessed from baseline to 12 hours post-infusion of adrenomedullin or placebo
Incidence of migraine attacks, defined by either: I. Headache fulfilling criteria C and D for migraine without aura according to ICHD-3 2 * Criterion C: At least two of the following: * Unilateral location * Pulsating quality * Moderate to severe pain intensity (≥4 on an 11-point numerical rating scale) * Aggravation by cough (in-hospital setting) or avoidance of routine physical activity (out-hospital setting) * Criterion D: At least one of the following: * Nausea and/or vomiting * Photophobia and phonophobia OR II. Headache that mimics the participant's usual spontaneous migraine attacks and is treated with acute migraine (rescue) medication.
1 secondary outcome
Headache intensity
Time frame: Assessed from baseline to 12 hours post-infusion of adrenomedullin or placebo
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- BackgroundDo TP, Younis S, Ashina M. Erenumab [Internet]. 2021. p. 121-9.Available from: https://link.springer.com/10.1007/978-3-030-69032-8_9
- Background: PubMed 29171821Goadsby PJ, Reuter U, Hallstrom Y, Broessner G, Bonner JH, Zhang F, Sapra S, Picard H, Mikol DD, Lenz RA. A Controlled Trial of Erenumab for Episodic Migraine. N Engl J Med. 2017 Nov 30;377(22):2123-2132. doi: 10.1056/NEJMoa1705848.
- Background: PubMed 28736918de Hoon J, Van Hecken A, Vandermeulen C, Yan L, Smith B, Chen JS, Bautista E, Hamilton L, Waksman J, Vu T, Vargas G. Phase I, Randomized, Double-blind, Placebo-controlled, Single-dose, and Multiple-dose Studies of Erenumab in Healthy Subjects and Patients With Migraine. Clin Pharmacol Ther. 2018 May;103(5):815-825. doi: 10.1002/cpt.799. Epub 2017 Oct 24.
- Background: PubMed 29263689Giamberardino MA, Affaitati G, Costantini R, Cipollone F, Martelletti P. Calcitonin gene-related peptide receptor as a novel target for the management of people with episodic migraine: current evidence and safety profile of erenumab. J Pain Res. 2017 Dec 8;10:2751-2760. doi: 10.2147/JPR.S128143. eCollection 2017.
- Background: PubMed 8989240Meeran K, O'Shea D, Upton PD, Small CJ, Ghatei MA, Byfield PH, Bloom SR. Circulating adrenomedullin does not regulate systemic blood pressure but increases plasma prolactin after intravenous infusion in humans: a pharmacokinetic study. J Clin Endocrinol Metab. 1997 Jan;82(1):95-100. doi: 10.1210/jcem.82.1.3656.
- Background: PubMed 28984313Ashina M, Hansen JM, A Dunga BO, Olesen J. Human models of migraine - short-term pain for long-term gain. Nat Rev Neurol. 2017 Dec;13(12):713-724. doi: 10.1038/nrneurol.2017.137. Epub 2017 Oct 6.
- Background: PubMed 29059473Hay DL, Garelja ML, Poyner DR, Walker CS. Update on the pharmacology of calcitonin/CGRP family of peptides: IUPHAR Review 25. Br J Pharmacol. 2018 Jan;175(1):3-17. doi: 10.1111/bph.14075. Epub 2017 Nov 28.
- Background: PubMed 33827963Ghanizada H, Al-Karagholi MA, Arngrim N, Morch-Rasmussen M, Walker CS, Hay DL, Ashina M. Effect of Adrenomedullin on Migraine-Like Attacks in Patients With Migraine: A Randomized Crossover Study. Neurology. 2021 May 18;96(20):e2488-e2499. doi: 10.1212/WNL.0000000000011930. Epub 2021 Apr 7.
- Background: PubMed 26559125Shi L, Lehto SG, Zhu DX, Sun H, Zhang J, Smith BP, Immke DC, Wild KD, Xu C. Pharmacologic Characterization of AMG 334, a Potent and Selective Human Monoclonal Antibody against the Calcitonin Gene-Related Peptide Receptor. J Pharmacol Exp Ther. 2016 Jan;356(1):223-31. doi: 10.1124/jpet.115.227793. Epub 2015 Nov 11.
- Background: PubMed 17261680Lipton RB, Bigal ME, Diamond M, Freitag F, Reed ML, Stewart WF; AMPP Advisory Group. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2007 Jan 30;68(5):343-9. doi: 10.1212/01.wnl.0000252808.97649.21.
- Background: PubMed 31113373Steiner TJ, Jensen R, Katsarava Z, Linde M, MacGregor EA, Osipova V, Paemeleire K, Olesen J, Peters M, Martelletti P. Aids to management of headache disorders in primary care (2nd edition) : on behalf of the European Headache Federation and Lifting The Burden: the Global Campaign against Headache. J Headache Pain. 2019 May 21;20(1):57. doi: 10.1186/s10194-018-0899-2.
- Background: PubMed 20473702Stovner LJ, Andree C. Prevalence of headache in Europe: a review for the Eurolight project. J Headache Pain. 2010 Aug;11(4):289-99. doi: 10.1007/s10194-010-0217-0. Epub 2010 May 16.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized data not published within this article will be made available on reasonable request from any qualified investigator
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adrenomedullin in people with Migraine and Brain Diseases, 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 3 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 28 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annette Maria Ellekaer Fuchs, PhD Fellow (+4526232421, annette.maria.ellekaer.fuchs@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of migraine attacks (time frame: Assessed from baseline to 12 hours post-infusion of adrenomedullin or placebo). 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 NCT07451769, which also lists 15 linked publications.
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 28 Aug 2026.