An interventional study of Amylin and Placebo in Headache Disorders, Secondary, Brain Diseases and Headache Disorders, sponsored by Danish Headache Center. Not yet recruiting at 1 site in Denmark. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-01-14.
Sponsored by Danish Headache Center · Not applicable, Interventional, and Basic science
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).
Amylin is a vasodilator released from nerve fibers within the trigeminovascular system, which is considered a key anatomical and physiological substrate in the pathogenesis of migraine and persistent post-traumatic headache (PTH). Persistent PTH attributed to mild traumatic brain injury frequently presents with migraine attacks, suggesting shared underlying mechanisms with migraine. This study aims to determine whether intravenous infusion of pramlintide, an analogue of amylin, can induce migraine-like headache in individuals with persistent post-traumatic headache. To test this hypothesis, we will conduct a randomized, double-blind, placebo-controlled, two-way crossover study.
192 studies on the registry are indexed under Post-Traumatic Headache; 54 are open to participants now.
This study's planned enrollment of 21 is below the median of 44 across 169 interventional studies indexed under Post-Traumatic Headache.
Browse Post-Traumatic Headache studies →Danish Headache Center is the lead sponsor of 129 studies on the registry; 15 are open to participants now.
Compared within Post-Traumatic Headache, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Headache Disorders, Secondary. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pramlintide (Amylin) will be administered by intravenous infusion.
Drug: Amylin
Placebo (isotonic saline) will be administered by intravenous infusion.
Drug: Placebo
The participants will receive continuous intravenous infusion of 6 μg/min of pramlintide (amylin) over 20 minutes.
The participants will receive continuous intravenous infusion of 20 mL of placebo (isotonic saline) over 20 minutes.
Incidence of migraine-like headache
Difference in incidence of migraine-like headache (0 to 12 hours) between pramlintide and placebo.
Time frame: 12 hours
Headache Intensity Scores
Difference in area under the curve (AUC) for headache intensity scores (0 to 12 hours) between pramlintide and placebo.
Time frame: 12 hours
Plan to share: Yes
Access criteria: Anonymized data not published within this article will be made available on reasonable request from any qualified investigator.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Islet Amyloid Polypeptide