Hypersensitivity to PACAP-38 in Post-Traumatic Headache

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    21
  • sponsor
    Danish Headache Center
Updated on 14 July 2022

Summary

The aim is to investigate whether signaling molecule PACAP-38 induces headache with migraine-like features in people with persistent post-traumatic headache (PTH) attributed to mild traumatic brain injury (mTBI).

Details
Condition Post-Traumatic Headache
Treatment Placebo, Pituitary adenylate cyclase activating polypeptide-38
Clinical Study IdentifierNCT05378061
SponsorDanish Headache Center
Last Modified on14 July 2022

Eligibility

Yes No Not Sure

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 headache with migraine-like features or self-reported baseline headache that mimics the subjects' usual headache with migraine-like features
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