Amylin-Induced Migraine Attacks Without Aura

Danish Headache Center

Status: Not yet enrolling

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

Treatments: Drug: Placebo; Drug: Amylin

Study type: Interventional

Funder types: Other

Identifiers

NCT07340788

H-24025082

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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
• Migraine attack within 48 hours of infusion start
• Aura within 48 hours of infusion start

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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21 participants in 2 patient groups, including a placebo group

Amylin

Experimental group

Description:

Pramlintide (Amylin) will be administered by intravenous infusion.

Treatment:

Drug: Amylin

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo