Hypersensitivity to Phosphodiesterase 3 Inhibition in Post-Traumatic Headache

Sponsor
Danish Headache Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05595993
Collaborator
(none)
21
2
14.2

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
21 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Hypersensitivity to Phosphodiesterase 3 Inhibition in Post-Traumatic Headache: A Randomized Clinical Trial
Anticipated Study Start Date :
Oct 25, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cilostazol

Oral administration of 200 mg cilostazol.

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

Placebo Comparator: Placebo

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

Outcome Measures

Primary Outcome Measures

  1. Incidence of Migraine-Like Headache [12 Hours]

    Difference in incidence of headache with migraine-like features (0 to 12 hours) between cilostazol and placebo.

Secondary Outcome Measures

  1. Headache Intensity Scores [12 Hours]

    Difference in area under the curve (AUC) for headache intensity scores (0 to 12 hours) between cilostazol and placebo.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Danish Headache Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Håkan Ashina, MD, Danish Headache Center
ClinicalTrials.gov Identifier:
NCT05595993
Other Study ID Numbers:
  • H-21067676
First Posted:
Oct 27, 2022
Last Update Posted:
Oct 27, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 27, 2022