Hypersensitivity to Opening of BKCa Channels in Post-Traumatic Headache

• Sponsor: Danish Headache Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05378074
• Collaborator: (none)
• Enrollment: 21
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 19
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

The aim is to investigate whether opening of large conductance calcium-activated potassium (BKCa) channels 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
Post-Traumatic Headache	Drug: Maxipost; Drug: Placebo	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 Opening of BKCa Channels in Post-Traumatic Headache: A Randomized Clinical Trial
• Anticipated Study Start Date: Jun 1, 2022
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MaxiPost A time- and volume-controlled infusion pump is used to administer MaxiPost by intravenous infusion over 20 minutes.	Drug: Maxipost; Study participants will be allocated to receive continuous intravenous infusion of 0.05 mg/min MaxiPost.
Placebo Comparator: Placebo (isotonic saline) A time- and volume-controlled infusion pump is used to administer placebo (isotonic saline) by intravenous infusion over 20 minutes.	Drug: Placebo; Study participants will be allocated to receive continuous intravenous infusion of 20 mL placebo (isotonic saline).; Other Names: Isotonic Saline

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 MaxiPost 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 levcromakalim 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

	Site	City	State	Country	Postal Code
1	Danish Headache Center	Copenhagen		Denmark	2600

Sponsors and Collaborators

• Danish Headache Center

Investigators

• Principal Investigator: Hakan Ashina, MD, Danish Headache Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Håkan Ashina, MD, Danish Headache Center
• ClinicalTrials.gov Identifier: NCT05378074
• Other Study ID Numbers: H-21048424
• First Posted: May 17, 2022
• Last Update Posted: May 18, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Håkan Ashina, MD, Danish Headache Center: Headache; Pain
• Additional relevant MeSH terms: Post-Traumatic Headache; Hypersensitivity; Headache

Study Results

No Results Posted as of May 18, 2022