Overview

Hypersensitivity to Phosphodiesterase 5 Inhibition in Post-Traumatic Headache

Status:
Not yet recruiting
Trial end date:
2023-12-31
Target enrollment:
0
Participant gender:
All
Summary
To investigate whether sildenafil (phosphodiesterase 5 inhibitor) induces migraine-like headache in people with persistent post-traumatic headache (PTH) attributed to mild traumatic brain injury (mTBI).
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Danish Headache Center
Treatments:
Sildenafil Citrate
Criteria
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