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Hypersensitivity to Phosphodiesterase 3 Inhibition in Post-Traumatic Headache

Primary Purpose

Post-Traumatic Headache

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Cilostazol
Placebo
Sponsored by
Danish Headache Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Post-Traumatic Headache

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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
  • 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

Sites / Locations

  • Danish Headache CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cilostazol

Placebo

Arm Description

Oral administration of 200 mg cilostazol.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 23, 2022
Last Updated
February 4, 2023
Sponsor
Danish Headache Center
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1. Study Identification

Unique Protocol Identification Number
NCT05595993
Brief Title
Hypersensitivity to Phosphodiesterase 3 Inhibition in Post-Traumatic Headache
Official Title
Hypersensitivity to Phosphodiesterase 3 Inhibition in Post-Traumatic Headache: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 25, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Headache Center

4. Oversight

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
Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Headache

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cilostazol
Arm Type
Experimental
Arm Description
Oral administration of 200 mg cilostazol.
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Cilostazol
Intervention Description
Study participants will be allocated to receive oral administration of 200 mg cilostazol.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Study participants will be allocated to receive oral administration of placebo.
Primary Outcome Measure Information:
Title
Incidence of Migraine-Like Headache
Description
Difference in incidence of headache with migraine-like features (0 to 12 hours) between cilostazol and placebo.
Time Frame
12 Hours
Secondary Outcome Measure Information:
Title
Headache Intensity Scores
Description
Difference in area under the curve (AUC) for headache intensity scores (0 to 12 hours) between cilostazol and placebo.
Time Frame
12 Hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hakan Ashina, MD
Phone
+4528102495
Email
haakan.ashina@regionh.dk
Facility Information:
Facility Name
Danish Headache Center
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hakan Ashina, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Hypersensitivity to Phosphodiesterase 3 Inhibition in Post-Traumatic Headache

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