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

Not Applicable

Completed

• Conditions: Post-Traumatic Headache
• Interventions: Drug: Placebo; Drug: Levcromakalim

• Registration Number: NCT05243953
• Lead Sponsor: Danish Headache Center

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-08
• Study First Submitted QC: 2022-02-16
• Study First Posted: 2022-02-17
• Study Start: 2022-03-21
• Status Verified: 2022-07
• Primary Completion: 2022-07-07
• Study Completion: 2022-07-07
• Last Update Submitted: 2022-07-07
• Last Update Posted: 2022-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo (isotonic saline)	Placebo	A time- and volume-controlled infusion pump is used to administer placebo (isotonic saline) by intravenous infusion over 20 minutes.
Levcromakalim	Levcromakalim	A time- and volume-controlled infusion pump is used to administer levcromakalim by intravenous infusion over 20 minutes.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Danish Headache Center; 🇩🇰 Copenhagen, Denmark