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Trial · Interventional

Not yet recruitingNot applicableRegistry data

Hypersensitivity to Amylin in Post-Traumatic Headache

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
Dec 2028 (estimated)
Completion
Dec 2028 (estimated)
First posted
14 Jan 2026
Last update posted
14 Jan 2026
Conditions
Headache Disorders, Secondary · Brain Diseases · Headache Disorders · Nervous System Diseases · Central Nervous System Diseases · Neurologic Manifestations · Signs and Symptoms · Pathological Conditions, Signs and Symptoms · Post-Traumatic 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

    Hypersensitivity to Amylin in Post-Traumatic Headache

    NCT07340775

    est. Feb 2026 to est. Dec 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 substance involved in the pathogenesis of headache. This study investigates whether pramlintide induces migraine-like headache in people with persistent post-traumatic headache (PTH) attributed to mild traumatic brain injury (mTBI).

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-like headache

    Time frame · 12 hours

    Registry description

    Difference in incidence of migraine-like headache (0 to 12 hours) between pramlintide and placebo.

Secondary outcomes(1)
  1. Headache Intensity Scores

    Time frame · 12 hours

    Registry description

    Difference in area under the curve (AUC) for headache intensity scores (0 to 12 hours) between pramlintide and placebo.

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 * History of persistent headache attributed to mild traumatic injury to the head for ≥ 12 months and in accordance with the International Classification of Headache Disorders, 3rd Edition (ICHD-3) * ≥ 4 monthly headache days on average across the 3 months prior to screening * Provision of informed consent prior to initiation of any study-specific activities/procedures Exclusion Criteria: * \> 1 mild traumatic injury to the head * History of any primary or secondary headache disorder prior to mild traumatic injury to the head (except for infrequent episodic tension-type headache) * History of moderate or severe injury to the head * History of whiplash injury * History of craniotomy * History or evidence of any other clinically significant disorder, condition or disease (except for those outlined above) than, in the opinion of the site investigator, would pose a risk to subject safety or interfere with study evaluation, procedures or completion * 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) * Initiation, discontinuation, or change of dosing of prophylactic medications within 2 months prior to study inclusion * Intake of acute medications (e.g. analgesics, triptans) within 48 hours of infusion start * Baseline headache intensity of \>3 on an 11-point numeric rating scale (0 being no headache, 10 being the worst imaginable headache) * Baseline migraine-like headache or self-reported baseline headache that mimics the subjects' usual migraine-like headache

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