Skip to main content
OpenTrials
Completed

NCT Number: NCT03212430

The Effect of Intravenous L-kynurenine (LKYN) on Cerebral Hemodynamics in Healthy Volunteers

To measure the cerebral hemodynamic effect of L-kynurenine.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Headache Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Rigshospitalet-Glostrup

Glostrup Municipality, Nordre Ringvej 57, 2600, Denmark

About this study

Aim: To investigate the physiological effect of L-Kynurenine after intravenous administration to healthy volunteers.

Hypothesis: L-kynurenine induces vasodilation in the cerebral vessels and trigger headache in healthy individuals.

Methods: 6 healthy volunteers will receive intravenous infusion of L-kynurenine using the following doses 50 microgram/kg, 100 microgram/kg, 150 microgram/kg, 300 microgram/kg, 500 microgram/kg, 1 mg/kg and 5 mg/kg over 20 min on 7 different days with at least 1 day in between. Before and after infusion (at 20, 40, 60, 80 and 100 min) we will record vital signs, circumferences of middle cerebral artery, superficial temporalis artery and headache intensity and characteristics.

The subjects will then have a questionnaire about headache for the following 24 hours.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy volunteers of both sexes.
  • 18-60 years.
  • 50-90 kg.
  • Women of childbearing potential must use adequate contraception.

Exclusion criteria

  • All primary headaches
  • First-degree relative with migraine
  • Headache less than 48 hours before the tests start
  • Daily consumption of drugs of any kind other than oral contraceptives.
  • Pregnant or nursing women. Cardiovascular disease of any kind, including cerebrovascular diseases.

Treatment and study plan

L-kynurenine

Drug

intravenous infusion of L-kynurenine to healthy individuals.

Primary outcomes

  1. Velocity of MCA (VMCA)

    Time frame: Change from baseline VMCA at two hours after administration of L-kynurenine

    Measured in MCA (middle cerebral artery) bilaterally with ultrasound (TCD) (2 Mhz, DWL)

  2. The diameter of the STA (superficial temporal artery)

    Time frame: Change from baseline VMCA at two hours after administration of L-kynurenine

    Measured by high-frequency ultrasound 12 of 29 (Derma Scan C, Cortex Technology, Denmark)

  3. Headache

    Time frame: occurrence of headache undtil 24 hours after infusion.

    Headache declared orally on a verbal rating scale (VRS) 0-10. 0 represents no pain and 10 the worst possible headache.

Sponsors and collaborators

Lead sponsor

Danish Headache Center

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 11, 2017
Registry last updated
Jan 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.