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Hypersensitivity to Amylin in Post-Traumatic Headache
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: 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
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)
| Facility | City | Region | Status |
| Rigshospitalet Glostrup |
Glostrup Municipality |
Denmark |
|
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