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

NCT05243953 | Completed

• 1 other identifier: H-21043704
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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).

Conditions

Post-Traumatic Headache

Keywords

Headache; Pain

Outcome Measures

Primary Outcomes (1)

• Incidence of Migraine-Like Headache

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

  12 Hours

Secondary Outcomes (1)

• Headache Intensity Scores

  12 Hours

Study Arms (2)

Levcromakalim

EXPERIMENTAL

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

Drug: Levcromakalim

Placebo (isotonic saline)

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Levcromakalim DRUG

Study participants will be allocated to receive continuous intravenous infusion of 0.05 mg/min (20 ml of 50 mg/ml) levcromakalim.

Levcromakalim

Placebo DRUG

Study participants will be allocated to receive continuous intravenous infusion of 20 mL placebo (isotonic saline).

Also known as: Isotonic Saline

Placebo (isotonic saline)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \> 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)
• 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

Sponsors & Collaborators

• Danish Headache Center: lead

Study Sites (1)

Danish Headache Center

Copenhagen, 2600, Denmark

Location

Related Publications (1)

• Al-Khazali HM, Christensen RH, Dodick DW, Chaudhry BA, Burstein R, Ashina H. Hypersensitivity to opening of ATP-sensitive potassium channels in post-traumatic headache. Cephalalgia. 2023 Nov;43(11):3331024231210930. doi: 10.1177/03331024231210930.

  PMID: 37917826 DERIVED

MeSH Terms

Conditions

Post-Traumatic Headache; Headache; Pain

Interventions

Cromakalim; Sodium Chloride

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Hakan Ashina, MD

  Danish Headache Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 17, 2022
• Study Start: March 21, 2022
• Primary Completion: July 7, 2022
• Study Completion: July 7, 2022
• Last Updated: July 8, 2022

Record last verified: 2022-07

Locations

DK (1)