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

Phase 1

Completed

• Conditions: Headache

• Registration Number: NCT03212430
• Lead Sponsor: Danish Headache Center

Brief Summary

To measure the cerebral hemodynamic effect of L-kynurenine.

Detailed Description

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.

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2017-07-04
• Study First Submitted QC: 2017-07-06
• Study First Posted: 2017-07-11
• Status Verified: 2019-01
• Primary Completion: 2019-01-20
• Study Completion: 2019-01-20
• Last Update Submitted: 2019-01-20
• Last Update Posted: 2019-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

1. Healthy volunteers of both sexes.
2. 18-60 years.
3. 50-90 kg.
4. Women of childbearing potential must use adequate contraception.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Velocity of MCA (VMCA)	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)
Headache	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.
The diameter of the STA (superficial temporal artery)	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)

Trial Locations

Locations (1)

Rigshospitalet-Glostrup; 🇩🇰 Glostrup, Nordre Ringvej 57, Denmark