Hypersensitivity to PACAP-38 in Post-Traumatic Headache

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