Hypersensitivity to Amylin in Post-Traumatic Headache

Starting soon · Not applicable · Has a placebo group

Conditions studied: 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

In brief

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).

Key facts

Study ID

NCT07340775

Run by

Danish Headache Center

People needed

21

Starts

2026-02-01

Expected to finish

2028-12-01

Last updated by the study team

2026-01-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• > 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

Where it is running

• Rigshospitalet Glostrup — Glostrup Municipality, Denmark

Full record on ClinicalTrials.gov

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