Status:
UNKNOWN
Hypersensitivity to PACAP-38 in Post-Traumatic Headache
Lead Sponsor:
Danish Headache Center
Conditions:
Post-Traumatic Headache
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 in...
Eligibility Criteria
Inclusion
- 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
- \> 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
Key Trial Info
Start Date :
June 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT05378061
Start Date
June 16 2022
End Date
December 31 2023
Last Update
June 22 2022
Active Locations (1)
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1
Danish Headache Center
Copenhagen, Denmark, 2600