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

To measure the cerebral hemodynamic effect of L-kynurenine.

Study Overview

• Status: Completed
• Conditions: Headache
• Intervention / Treatment: Drug: 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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• Denmark
  • Nordre Ringvej 57
    • Glostrup, Nordre Ringvej 57, Denmark, 2600
      • Rigshospitalet-Glostrup

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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.

Collaborators and Investigators

• Sponsor: Danish Headache Center
• Investigators: Principal Investigator: Messoud Ashina, Professor, Professor of Neurology

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2017
• Primary Completion (ACTUAL): January 20, 2019
• Study Completion (ACTUAL): January 20, 2019

Study Registration Dates

• First Submitted: July 4, 2017
• First Submitted That Met QC Criteria: July 6, 2017
• First Posted (ACTUAL): July 11, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 23, 2019
• Last Update Submitted That Met QC Criteria: January 20, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Headache; Cerebral hemodynamic; L-kynurenine; Mohammad Al-Mahdi Al-Karagholi
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Headache
• Other Study ID Numbers: L-kynurenin H-16033148

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 1. Using a controlled access approach, using a transparent and robust system to review requests and provide secure data access; 2. seeking consent for sharing IPD from trial participants in all future clinical trials with adequate assurance that patient privacy and confidentiality can be maintained; and 3. Establishing an approach to resource the sharing of IPD which would include support from trial funders, sponsor organisations and users of IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No