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

Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03212430
• Other study ID #: L-kynurenin H-16033148
• Status: Completed
• Phase: Phase 1
• Start date: March 1, 2017
• Est. completion date: January 20, 2019

Study information

• Verified date: January 2019
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To measure the cerebral hemodynamic effect of L-kynurenine.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: January 20, 2019
• Est. primary completion date: January 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Headache

Intervention

Drug:
• L-kynurenine
intravenous infusion of L-kynurenine to healthy individuals.

Locations

Country	Name	City	State
Denmark	Rigshospitalet-Glostrup	Glostrup	Nordre Ringvej 57

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Velocity of MCA (VMCA)	Measured in MCA (middle cerebral artery) bilaterally with ultrasound (TCD) (2 Mhz, DWL)	Change from baseline VMCA at two hours after administration of L-kynurenine
Primary	The diameter of the STA (superficial temporal artery)	Measured by high-frequency ultrasound 12 of 29 (Derma Scan C, Cortex Technology, Denmark)	Change from baseline VMCA at two hours after administration of L-kynurenine
Primary	Headache	Headache declared orally on a verbal rating scale (VRS) 0-10. 0 represents no pain and 10 the worst possible headache.	occurrence of headache undtil 24 hours after infusion.