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Hypersensitivity to Phosphodiesterase 5 Inhibition in Post-Traumatic Headache | Clinical Trials | Clareo Health

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Hypersensitivity to Phosphodiesterase 5 Inhibition in Post-Traumatic Headache

Hypersensitivity to Phosphodiesterase 5 Inhibition in Post-Traumatic Headache: A Randomized Clinical Trial

NCT05669885•Danish Headache Center

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).

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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
+5 more criteria

Locations (1)

Danish Headache Center

Copenhagen, Denmark

Key Dates

Start Date

January 2, 2023

Primary Completion Date

December 31, 2023

Completion Date

December 31, 2023

Last Updated

February 8, 2023

Enrollment

ESTIMATED participants

Conditions

Post-Traumatic Headache

Interventions

Sildenafil

DRUG

Placebo

DRUG

Contacts

Hakan Ashina, MD

CONTACT

+4528102495 haakan.ashina@regionh.dk

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COMPLETEDNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 8, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Hypersensitivity to Phosphodiesterase 5 Inhibition in Post-Traumatic Headache

Inclusion Criteria

Exclusion Criteria

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