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Trial · Interventional

Not yet recruitingNot applicableRegistry data

Amylin-Induced Migraine Attacks Without Aura

This trial does not test a peptide that PepBank tracks.

  • Measures Pramlintide (Symlin), does not give it. It appears in an outcome measure.

Overview

Status
Not yet recruiting
Phase
Not applicable
Enrollment
21 participants (estimated)
Sponsor
Danish Headache Center · Other
Design
Randomized · Quadruple masking
Countries
1 country

Denmark

Start
Feb 2026 (estimated)
Primary completion
30 Oct 2028 (estimated)
Completion
30 Oct 2028 (estimated)
First posted
14 Jan 2026
Last update posted
14 Jan 2026
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

Timeline

1 trial · 1 not yet recruiting

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2026202720282029
  1. N/A

    Amylin-Induced Migraine Attacks Without Aura

    NCT07340788

    est. Feb 2026 to est. 30 Oct 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • AmylinDrug
  • PlaceboDrug

Arms2

  • Experimental

    Amylin

    Pramlintide (Amylin) will be administered by intravenous infusion.

  • Placebo comparator

    Placebo

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Incidence of migraine attacks without aura

    Time frame · 12 hours

    Registry description

    The difference in the incidence of migraine attacks without aura between pramlintide and placebo during the 12-hour observational period after infusion start.

Secondary outcomes(1)
  1. Headache intensity scores

    Time frame · 12 hours

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2021

5 results

Amylin Analog Pramlintide Induces Migraine-like Attacks in Patients.

Ghanizada et al. 2021Annals of neurologycited by 92

PMID 33772845PMC8486152DOI 10.1002/ana.26072PUB-33772845

Rights unknown5 results

Indexing hint: Randomized controlled trial · 2010

1 result

Do the actions of glucagon-like peptide-1 on gastric emptying, appetite, and food intake involve release of amylin in humans?

Asmar et al. 2010The Journal of clinical endocrinology and metabolismcited by 34

PMID 20194711DOI 10.1210/jc.2009-2133PUB-20194711

Full text at the publisher1 result

More studies

1 study on this page

Indexing hint: Review · 2015

Amylin: Pharmacology, Physiology, and Clinical Potential.

Hay et al. 2015Pharmacological reviewscited by 318

PMID 26071095DOI 10.1124/pr.115.010629PUB-26071095

Rights unknown
Source link

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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