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Starting soon Not applicable

Hypersensitivity to Amylin in Post-Traumatic Headache

NCT07340775 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2026-02
Last updated
2026-01-14

Condition(s) studied

Headache Disorders, SecondaryBrain DiseasesHeadache DisordersNervous System DiseasesCentral Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPost-Traumatic HeadachePainPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsAmylinPramlintide

Investigational drug(s) / intervention(s)

Amylin →Placebo

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

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

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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

Primary outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
Rigshospitalet Glostrup Glostrup Municipality Denmark
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07340775 on ClinicalTrials.gov ↗ ← All trials in Denmark