The Effect of Intravenous L-kynurenine (LKYN) on Cerebral Hemodynamics in Healthy Volunteers
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|ClinicalTrials.gov Identifier: NCT03212430|
Recruitment Status : Completed
First Posted : July 11, 2017
Last Update Posted : January 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Headache||Drug: L-kynurenine||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Pilot, Open label|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||The Effect of Intravenous L-kynurenine (LKYN) on Cerebral Hemodynamics in Healthy Volunteers|
|Actual Study Start Date :||March 1, 2017|
|Actual Primary Completion Date :||January 20, 2019|
|Actual Study Completion Date :||January 20, 2019|
- Drug: L-kynurenine
intravenous infusion of L-kynurenine to healthy individuals.
- 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)
- 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)
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03212430
|Glostrup, Nordre Ringvej 57, Denmark, 2600|
|Principal Investigator:||Messoud Ashina, Professor||Professor of neurology|