Hypersensitivity to Phosphodiesterase 3 Inhibition in Post-Traumatic Headache

NCT ID: NCT05595993

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-25
• Study Completion Date: 2023-12-31

Brief Summary

To investigate whether cilostazol (phosphodiesterase 3 inhibitor) induces headache with migraine-like features in people with persistent post-traumatic headache (PTH) attributed to mild traumatic brain injury (mTBI).

Conditions

Post-Traumatic Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Cilostazol

Oral administration of 200 mg cilostazol.

Group Type: EXPERIMENTAL

Cilostazol

Intervention Type: DRUG

Study participants will be allocated to receive oral administration of 200 mg cilostazol.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Study participants will be allocated to receive oral administration of placebo.

Interventions

Cilostazol

Study participants will be allocated to receive oral administration of 200 mg cilostazol.

Intervention Type: DRUG

Placebo

Study participants will be allocated to receive oral administration of placebo.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Danish Headache Center

OTHER

Sponsor Role: lead

Responsible Party

Håkan Ashina

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Danish Headache Center

Copenhagen, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Hakan Ashina, MD

Role: CONTACT

haakan.ashina@regionh.dk

+4528102495

Facility Contacts

Hakan Ashina, MD

Role: primary

References

Al-Khazali HM, Christensen RH, Chaudhry BA, Melchior AG, Ashina M, Burstein R, Ashina H. Effects of PDE-3 inhibition in persistent post-traumatic headache: evidence of cAMP-dependent signaling. J Headache Pain. 2024 Apr 17;25(1):56. doi: 10.1186/s10194-024-01762-x.

Reference Type: DERIVED

PMID: 38627631 (View on PubMed)

Other Identifiers

H-21067676

Identifier Type: -

Identifier Source: org_study_id