Headache Disorders, PrimaryNCT07340788
Amylin-Induced Migraine Attacks Without Aura
A study testing Amylin in people with Headache Disorders, Primary and Headache Disorders, run by Danish Headache Center at 1 site in Denmark.
Trial summary
Pramlintide is a peptide analogue of human amylin which is a vasoactive signaling molecule involved in the pathogenesis of migraine. This study investigates whether pramlintide induces migraine attacks without aura in people with migraine without aura. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Headache Disorders, Primary, Headache Disorders, Brain Diseases
- What is being tested?
- Amylin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2026to 30 Oct 2028
- 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
- Age 18 to 65 years of age upon entry into screening
- A body weight of 50 to 100 kg
- History of migraine without aura for ≥12 months and in accordance with ICHD-3
- Between 1-5 monthly migraine days without aura on average across the 3 months prior to screening
- Provision of informed consent prior to initiation of any study-specific activities/procedures
Who cannot join
- Any history of a primary or secondary headache disorder other than migraine without aura and infrequent episodic tension-type headache
- Any history of moderate to severe traumatic brain injury
- Any history of cardiovascular disease, including cerebrovascular diseases
- Any history of pulmonary disease
- Any other clinically significant disorders, conditions, or diseases that might impact the safety of the subject or interfere with the study's evaluation, procedures, or completion, aside from those mentioned above. This includes any relevant medical history or evidence that, in the opinion of the site investigator, might pose a risk to the subject or impact the validity of the study results
- The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior
Show all 17Show fewer
- Female subjects of childbearing potential with a positive pregnancy test during any study visit
- Cardiovascular disease of any kind, including cerebrovascular diseases
- Hypertension (systolic blood pressure of ≥150 mmHg and/or diastolic blood pressure of ≥100 mmHg) prior to the start of infusion on the experimental day
- Hypotension (systolic blood pressure of ≤90 mmHg and/or diastolic blood pressure of ≤50 mmHg)
- Abnormalities on the electrocardiogram that, in the opinion of the site investigator, might pose a risk to the subject or impact the validity of the study results
- Daily use of any medication other than contraceptives
- Intake of any medication other than contraceptives within 48 hours of infusion start
- Intake of caffeine, nicotine, and alcohol within 12 hours of infusion start
- Headache of any intensity within 48 hours of infusion start
- Migraine attack within 48 hours of infusion start
- Aura within 48 hours of infusion start
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
Rigshospitalet Glostrup
Glostrup Municipality, 2600
Haidar Al-Khazali, MD, PhD, +4541598494, haidardk@hotmail.com
Hakan Ashina, MD, PhD, +4528102495, haakan.ashina@regionh.dk
About this study
Official title: Amylin-Induced Migraine Attacks Without Aura: A Randomized Clinical Trial
Pramlintide is a peptide analogue of human amylin which is a vasoactive signaling molecule involved in the pathogenesis of migraine. This study investigates whether pramlintide induces migraine attacks without aura in people with migraine without aura.
Read the detailed description
Amylin is a vasoactive substance that acts on vascular smooth muscle and can cause vasodilation. It is naturally present in the trigeminovascular system, an important structure involved in headache development. Recent studies indicate that intravenous infusion of pramlintide, an amylin analogue, can trigger migraine attacks in people with migraine. This study aims to determine whether intravenous pramlintide can induce migraine attacks without aura in individuals who experience migraine without aura. To test this, the investigators will conduct a randomized, double-blind, placebo-controlled, two-way crossover trial.
- Conditions
- Headache Disorders, Primary, Headache Disorders, Brain Diseases, Nervous System Diseases, Central Nervous System Diseases, Neurologic Manifestations
- Being tested
- Amylin, Placebo
- Keywords
- Migraine, Headache, Pain, Amylin
- Medical subject headings
- Headache Disorders, Primary, Headache Disorders, Brain Diseases, Nervous System Diseases, Central Nervous System Diseases, Neurologic Manifestations, Signs and Symptoms, Pathological Conditions, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmylinDrug
The participants will receive continuous intravenous infusion of 20 mL (6 μg/min) of pramlintide (amylin) over 20 minutes.
PlaceboDrug
The participants will receive continuous intravenous infusion of 20 mL of placebo (isotonic saline) over 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Amylin | Experimental | Pramlintide (Amylin) will be administered by intravenous infusion. Receives: Drug: Amylin |
| Placebo | Placebo comparator | Placebo (isotonic saline) will be administered by intravenous infusion. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of migraine attacks without aura
The difference in the incidence of migraine attacks without aura between pramlintide and placebo during the 12-hour observational period after infusion start.
Measured: 12 hours
Secondary outcomes (1)
Headache intensity scores
The secondary outcome is the difference in the area under the curve (AUC) for median headache intensity scores between pramlintide and placebo during the 12-hour observational period after infusion start.
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completion30 Oct 2028 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Headache Disorders, PrimaryStudies 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
- 21 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
- NCT07340788
- Sponsor's protocol ID
- H-24025082
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Asmar M, Bache M, Knop FK, Madsbad S, Holst JJ. Do the actions of glucagon-like peptide-1 on gastric emptying, appetite, and food intake involve release of amylin in humans? J Clin Endocrinol Metab. 2010 May;95(5):2367-75. doi: 10.1210/jc.2009-2133. Epub 2010 Mar 1.
PubMed 20194711Hay DL, Chen S, Lutz TA, Parkes DG, Roth JD. Amylin: Pharmacology, Physiology, and Clinical Potential. Pharmacol Rev. 2015 Jul;67(3):564-600. doi: 10.1124/pr.115.010629.
PubMed 26071095Ghanizada H, Al-Karagholi MA, Walker CS, Arngrim N, Rees T, Petersen J, Siow A, Morch-Rasmussen M, Tan S, O'Carroll SJ, Harris P, Skovgaard LT, Jorgensen NR, Brimble M, Waite JS, Rea BJ, Sowers LP, Russo AF, Hay DL, Ashina M. Amylin Analog Pramlintide Induces Migraine-like Attacks in Patients. Ann Neurol. 2021 Jun;89(6):1157-1171. doi: 10.1002/ana.26072. Epub 2021 Apr 8.
PubMed 33772845Hansen JM, Hauge AW, Olesen J, Ashina M. Calcitonin gene-related peptide triggers migraine-like attacks in patients with migraine with aura. Cephalalgia. 2010 Oct;30(10):1179-86. doi: 10.1177/0333102410368444. Epub 2010 May 12.
PubMed 20855363Ashina M, Hansen JM, Do TP, Melo-Carrillo A, Burstein R, Moskowitz MA. Migraine and the trigeminovascular system-40 years and counting. Lancet Neurol. 2019 Aug;18(8):795-804. doi: 10.1016/S1474-4422(19)30185-1. Epub 2019 May 31.
PubMed 31160203Ashina 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 33773610Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.
PubMed 29368949Ashina 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 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amylin-Induced Migraine Attacks Without Aura: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07340788
- Acronym / sponsor ID
- H-24025082
- Conditions
- Headache Disorders, Primary, Headache Disorders, Brain Diseases, Nervous System Diseases, Central Nervous System Diseases, Neurologic Manifestations
- Keywords
- Migraine, Headache, Pain, Amylin
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- 30 Oct 2028 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 14 Jan 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.
Pramlintide is a peptide analogue of human amylin which is a vasoactive signaling molecule involved in the pathogenesis of migraine. This study investigates whether pramlintide induces migraine attacks without aura in people with migraine without aura.
Detailed description
Amylin is a vasoactive substance that acts on vascular smooth muscle and can cause vasodilation. It is naturally present in the trigeminovascular system, an important structure involved in headache development. Recent studies indicate that intravenous infusion of pramlintide, an amylin analogue, can trigger migraine attacks in people with migraine. This study aims to determine whether intravenous pramlintide can induce migraine attacks without aura in individuals who experience migraine without aura. To test this, the investigators will conduct a randomized, double-blind, placebo-controlled, two-way crossover trial.
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 |
|---|---|---|
| Amylin | Experimental | Drug: AmylinPramlintide (Amylin) will be administered by intravenous infusion. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (isotonic saline) will be administered by intravenous infusion. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 to 65 years of age upon entry into screening
- A body weight of 50 to 100 kg
- History of migraine without aura for ≥12 months and in accordance with ICHD-3
- Between 1-5 monthly migraine days without aura on average across the 3 months prior to screening
- Provision of informed consent prior to initiation of any study-specific activities/procedures
Key exclusion criteria (17 listed)
- Any history of a primary or secondary headache disorder other than migraine without aura and infrequent episodic tension-type headache
- Any history of moderate to severe traumatic brain injury
- Any history of cardiovascular disease, including cerebrovascular diseases
- Any history of pulmonary disease
- Any other clinically significant disorders, conditions, or diseases that might impact the safety of the subject or interfere with the study's evaluation, procedures, or completion, aside from those mentioned above. This includes any relevant medical history or evidence that, in the opinion of the site investigator, might pose a risk to the subject or impact the validity of the study results
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 |
|---|---|---|
| AmylinThe participants will receive continuous intravenous infusion of 20 mL (6 μg/min) of pramlintide (amylin) over 20 minutes. | Drug | Amylin |
| PlaceboThe participants will receive continuous intravenous infusion of 20 mL of placebo (isotonic saline) over 20 minutes. | Drug | Placebo |
Primary outcome
Incidence of migraine attacks without aura
Time frame: 12 hours
The difference in the incidence of migraine attacks without aura between pramlintide and placebo during the 12-hour observational period after infusion start.
1 secondary outcome
Headache intensity scores
Time frame: 12 hours
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 14 Jan 2026.
- Background: PubMed 20194711Asmar M, Bache M, Knop FK, Madsbad S, Holst JJ. Do the actions of glucagon-like peptide-1 on gastric emptying, appetite, and food intake involve release of amylin in humans? J Clin Endocrinol Metab. 2010 May;95(5):2367-75. doi: 10.1210/jc.2009-2133. Epub 2010 Mar 1.
- Background: PubMed 26071095Hay DL, Chen S, Lutz TA, Parkes DG, Roth JD. Amylin: Pharmacology, Physiology, and Clinical Potential. Pharmacol Rev. 2015 Jul;67(3):564-600. doi: 10.1124/pr.115.010629.
- Background: PubMed 33772845Ghanizada H, Al-Karagholi MA, Walker CS, Arngrim N, Rees T, Petersen J, Siow A, Morch-Rasmussen M, Tan S, O'Carroll SJ, Harris P, Skovgaard LT, Jorgensen NR, Brimble M, Waite JS, Rea BJ, Sowers LP, Russo AF, Hay DL, Ashina M. Amylin Analog Pramlintide Induces Migraine-like Attacks in Patients. Ann Neurol. 2021 Jun;89(6):1157-1171. doi: 10.1002/ana.26072. Epub 2021 Apr 8.
- Background: PubMed 20855363Hansen JM, Hauge AW, Olesen J, Ashina M. Calcitonin gene-related peptide triggers migraine-like attacks in patients with migraine with aura. Cephalalgia. 2010 Oct;30(10):1179-86. doi: 10.1177/0333102410368444. Epub 2010 May 12.
- Background: PubMed 31160203Ashina M, Hansen JM, Do TP, Melo-Carrillo A, Burstein R, Moskowitz MA. Migraine and the trigeminovascular system-40 years and counting. Lancet Neurol. 2019 Aug;18(8):795-804. doi: 10.1016/S1474-4422(19)30185-1. Epub 2019 May 31.
- Background: PubMed 33773610Ashina 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.
- Background: PubMed 29368949Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.
- Background: PubMed 33211930Ashina M. Migraine. N Engl J Med. 2020 Nov 5;383(19):1866-1876. doi: 10.1056/NEJMra1915327. No abstract available.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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 Amylin in people with Headache Disorders, Primary and Headache Disorders, 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 5 inclusion and 17 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: opening soon, as of the sponsor's last update on 14 Jan 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 Haidar Al-Khazali, MD, PhD (+4541598494, haidardk@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of migraine attacks without aura (time frame: 12 hours). 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 NCT07340788, which also lists 8 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 14 Jan 2026.