Amylin-Induced Migraine Attacks Without Aura

NCT07340788 | Not Yet Recruiting DMC

• 1 other identifier: H-24025082
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Nervous System Diseases; Central Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Migraine Disorders; Headache; Pain; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Amylin; Pramlintide

Keywords

Migraine; Headache; Pain; Amylin

Outcome Measures

Primary Outcomes (1)

• 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.

  12 hours

Secondary Outcomes (1)

• Headache intensity scores

  12 hours

Other Outcomes (2)

• Superficial temporal artery dilation

  2 hours

• Middle cerebral artery blood flow velocity

  2 hours

Study Arms (2)

Amylin

EXPERIMENTAL

Pramlintide (Amylin) will be administered by intravenous infusion.

Drug: Amylin

Placebo

PLACEBO COMPARATOR

Placebo (isotonic saline) will be administered by intravenous infusion.

Drug: Placebo

Interventions

Amylin DRUG

The participants will receive continuous intravenous infusion of 20 mL (6 μg/min) of pramlintide (amylin) over 20 minutes.

Amylin

Placebo DRUG

The participants will receive continuous intravenous infusion of 20 mL of placebo (isotonic saline) over 20 minutes.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Danish Headache Center: lead

Study Sites (1)

Rigshospitalet Glostrup

Glostrup Municipality, 2600, Denmark

Location

Related Publications (8)

• 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.

  PMID: 20194711 BACKGROUND

• Hay 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.

  PMID: 26071095 BACKGROUND

• Ghanizada 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.

  PMID: 33772845 BACKGROUND

• Hansen 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.

  PMID: 20855363 BACKGROUND

• Ashina 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.

  PMID: 31160203 BACKGROUND

• Ashina 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.

  PMID: 33773610 BACKGROUND

• Headache 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.

  PMID: 29368949 BACKGROUND

• Ashina M. Migraine. N Engl J Med. 2020 Nov 5;383(19):1866-1876. doi: 10.1056/NEJMra1915327. No abstract available.

  PMID: 33211930 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Nervous System Diseases; Central Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Migraine Disorders; Headache; Pain

Interventions

Islet Amyloid Polypeptide

Intervention Hierarchy (Ancestors)

Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Amyloidogenic Proteins; Amyloid; Proteins

Central Study Contacts

Haidar Al-Khazali, MD, PhD

CONTACT

+4541598494; haidardk@hotmail.com

Hakan Ashina, MD, PhD

CONTACT

+4528102495; haakan.ashina@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This single-center trial applies a randomized, double-blind, placebo-controlled, two-way crossover design.

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 14, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): October 30, 2028
• Study Completion (Estimated): October 30, 2028
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Access Criteria: Anonymized data not published within this article will be made available on reasonable request from any qualified investigator.

Locations

DK (1)