The Effect of Levcromakalim Infusion on the Cranial Arteries Over Several Hours Using a High Resolution MRA Technique in a Randomized, Double-blind Placebo-controlled Design in Healthy Volunteers.

NCT03609008 | Completed DMC

• 1 other identifier: Levcromakalim & MRI
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Healthy participants vill randomly be allocated in a 2:1 order to receive 1 mg levcromakalim or placebo (isotonic saline) for 20 min. The investigator here examine the effect of levcromakalim infusion on the MMA and the MCA circumference over several hours using a high resolution MRA technique in a randomized, double-blind placebo-controlled design in healthy volunteers. The investigator hypothesized that levcromakalim induces dilatation of cranial arteries.

Conditions

Dilatation of Cranial Arteries; MMA, STA and MCA; Headache

Outcome Measures

Primary Outcomes (1)

• Change is assessed of cranaial arteries; MMA, STA and MCA

  The investigator will obtain repeated MRA measurements covering the diameter of MMA and MCA before and after levcromakalim/placebo infusion.

  Before and after infusion of levcromakalim compared with before and after infusion of saline. Time of measurements is baseline, 20 min, 110 min, 200 min, 290 min and 350 min after the infusion.

Secondary Outcomes (1)

• Headache

  Before (-10 min) and after infusion (+16 hours) of levcromakalim compared with before and after infusion of saline

Study Arms (2)

Levcromakalim

ACTIVE COMPARATOR

18 participants will randomly be allocated in a 2:1 order to receive 1 mg levcromakalim or placebo (isotonic saline)

Drug: Levcromakalim

Saline

PLACEBO COMPARATOR

18 participants will randomly be allocated in a 2:1 order to receive 1 mg levcromakalim or placebo (isotonic saline)

Drug: Saline

Interventions

Levcromakalim DRUG

Intravenous administration of levcromakalim or placebo for 20 minutes. To investigate the role of levcromakalim/placebo on cerebral hemodynamic in healthy volunteers.

Levcromakalim

Saline DRUG

Intravenous administration of levcromakalim or placebo for 20 minutes. To investigate the role of levcromakalim/placebo on cerebral hemodynamic in healthy volunteers.

Saline

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers of both sexes.
• years.
• kg.
• Women of childbearing potential must use adequate contraception.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Danish Headache Center: lead

Study Sites (1)

Danish headache center

Copenhagen, Glostrup, 2600, Denmark

Location

Related Publications (1)

• Al-Karagholi MA, Ghanizada H, Hansen JM, Skovgaard LT, Olesen J, Larsson HBW, Amin FM, Ashina M. Levcromakalim, an Adenosine Triphosphate-Sensitive Potassium Channel Opener, Dilates Extracerebral but not Cerebral Arteries. Headache. 2019 Oct;59(9):1468-1480. doi: 10.1111/head.13634. Epub 2019 Sep 18.

  PMID: 31535367 DERIVED

MeSH Terms

Conditions

Headache

Interventions

Cromakalim; Sodium Chloride

Condition Hierarchy (Ancestors)

Pain; 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 Design

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

Model Details: Randomized, double-blind placebo-controlled study with healthy volunteers.

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: August 1, 2018
• Study Start: June 26, 2018
• Primary Completion: August 15, 2018
• Study Completion: August 15, 2018
• Last Updated: July 5, 2022

Record last verified: 2022-07

Locations

DK (1)