The Hemodynamics Effect of Glibenclamide on Levcromakalim Assessed by High Resolution Magnetic Resonance Angiography (MRA) Technique in a Randomized Double-blind Cross-over Placebo-controlled Study With Healthy Volunteers

Danish Headache Center

Status: Enrolling

Conditions: Cerebral Blood Flow; Hemodynamics of Cranial Arteries; Headache

Treatments: Drug: Saline; Drug: Levcromakalim

Study type: Interventional

Funder types: Other

Identifiers

NCT03886922

Glibenclamide H-18052188

Details and patient eligibility

About

To investigate the effect of levcromakalim/placebo infusion on cranial arteries after glibenclamide administration.

Full description

15 healthy participants will randomly be allocated to receive levcromakalim or placebo on to different days before and after oral glibenclamide administration.

The aim of the study is to investigate the effect of levcromakalim/placebo infusion on cranial arteries before and after glibenclamide administration.

Repeated magnetic resonance angiography (MRA) measurements covering the middle meningeal artery (MMA), superficial temporal artery (STA) and middle cerebral artery (MCA) before and after glibenclamide administration and levcromakalim/placebo infusion.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteers of both sexes.
• 18-60 years.
• 50-100 kg.
• Women of childbearing potential must use adequate contraception

Exclusion criteria

• A history of serious somatic disease
• Migraine or any other type of headache (except episodic tension-type headache less than once a month)
• Daily intake of any medication except contraceptives
• Contraindications for MRI scan.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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15 participants in 5 patient groups

Glibenclamide and Levcromakalim

Active Comparator group

Description:

Participants will receive levcromakalim infusion after glibenclamide administration

Treatment:

Drug: Levcromakalim

Glibenclamide and Saline

Active Comparator group

Description:

Participants will receive placebo infusion after glibenclamide administration

Treatment:

Drug: Saline

Placebo

Sham Comparator group

Description:

Participants will receive placebo infusion after placebo administration.

Treatment:

Drug: Saline

Levcromakalim and Glibenclamide

Active Comparator group

Description:

Participants will receive levcromakalim infusion before glibenclamide administration.

Treatment:

Drug: Levcromakalim

Levcromakalim and Placebo

Active Comparator group

Description:

Participants will receive levcromakalim infusion before placebo administration.

Treatment:

Drug: Saline

Drug: Levcromakalim