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Hypersensitivity to Opening of ATP-Sensitive Potassium Channels in Post-Traumatic Headache

Primary Purpose

Post-Traumatic Headache

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Levcromakalim
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 focused on measuring Headache, Pain

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 Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Levcromakalim

Placebo (isotonic saline)

Arm Description

A time- and volume-controlled infusion pump is used to administer levcromakalim by intravenous infusion over 20 minutes.

A time- and volume-controlled infusion pump is used to administer placebo (isotonic saline) by intravenous infusion over 20 minutes.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 8, 2022
Last Updated
July 7, 2022
Sponsor
Danish Headache Center
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1. Study Identification

Unique Protocol Identification Number
NCT05243953
Brief Title
Hypersensitivity to Opening of ATP-Sensitive Potassium Channels in Post-Traumatic Headache
Official Title
Hypersensitivity to Opening of ATP-Sensitive Potassium Channels in Post-Traumatic Headache: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
March 21, 2022 (Actual)
Primary Completion Date
July 7, 2022 (Actual)
Study Completion Date
July 7, 2022 (Actual)

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim is to investigate whether opening of ATP-sensitive potassium (KATP) channels 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
Keywords
Headache, Pain

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Levcromakalim
Arm Type
Experimental
Arm Description
A time- and volume-controlled infusion pump is used to administer levcromakalim by intravenous infusion over 20 minutes.
Arm Title
Placebo (isotonic saline)
Arm Type
Placebo Comparator
Arm Description
A time- and volume-controlled infusion pump is used to administer placebo (isotonic saline) by intravenous infusion over 20 minutes.
Intervention Type
Drug
Intervention Name(s)
Levcromakalim
Intervention Description
Study participants will be allocated to receive continuous intravenous infusion of 0.05 mg/min (20 ml of 50 mg/ml) levcromakalim.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Isotonic Saline
Intervention Description
Study participants will be allocated to receive continuous intravenous infusion of 20 mL placebo (isotonic saline).
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 levcromakalim 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 levcromakalim 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hakan Ashina, MD
Organizational Affiliation
Danish Headache Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Danish Headache Center
City
Copenhagen
ZIP/Postal Code
2600
Country
Denmark

12. IPD Sharing Statement

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Hypersensitivity to Opening of ATP-Sensitive Potassium Channels in Post-Traumatic Headache

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