Hypersensitivity to Opening of BKCa Channels in Post-Traumatic Headache

NCT ID: NCT05378074

Last Updated: 2022-09-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2023-12-31

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).

Conditions

Post-Traumatic Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

MaxiPost

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

Group Type: EXPERIMENTAL

Maxipost

Intervention Type: DRUG

Study participants will be allocated to receive continuous intravenous infusion of 0.05 mg/min MaxiPost.

Placebo (isotonic saline)

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Maxipost

Study participants will be allocated to receive continuous intravenous infusion of 0.05 mg/min MaxiPost.

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Isotonic Saline

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Danish Headache Center

OTHER

Sponsor Role: lead

Responsible Party

Håkan Ashina

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hakan Ashina, MD

Role: PRINCIPAL_INVESTIGATOR

Danish Headache Center

Locations

Danish Headache Center

Copenhagen, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Hakan Ashina, MD

Role: CONTACT

haakan.ashina@regionh.dk

00 45 28 10 24 95

Facility Contacts

Håkan Ashina, MD

Role: primary

haakan.ashina@regionh.dk

+45 28 10 24 95

References

Al-Khazali HM, Christensen RH, Dodick DW, Chaudhry BA, Melchior AG, Burstein R, Ashina H. Hypersensitivity to BKCa channel opening in persistent post-traumatic headache. J Headache Pain. 2024 Jun 18;25(1):102. doi: 10.1186/s10194-024-01808-0.

Reference Type: DERIVED

PMID: 38890563 (View on PubMed)

Other Identifiers

H-21048424

Identifier Type: -

Identifier Source: org_study_id