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

Sponsor
Danish Headache Center (Other)
Overall Status
Completed
CT.gov ID
NCT03212430
Collaborator
(none)
6
Enrollment
1
Location
22.7
Actual Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To measure the cerebral hemodynamic effect of L-kynurenine.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Pilot, Open labelPilot, Open label
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Other
Official Title:
The Effect of Intravenous L-kynurenine (LKYN) on Cerebral Hemodynamics in Healthy Volunteers
Actual Study Start Date :
Mar 1, 2017
Actual Primary Completion Date :
Jan 20, 2019
Actual Study Completion Date :
Jan 20, 2019

Outcome Measures

Primary Outcome Measures

  1. 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)

  2. 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)

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rigshospitalet-Glostrup Glostrup Nordre Ringvej 57 Denmark 2600

Sponsors and Collaborators

  • Danish Headache Center

Investigators

  • Principal Investigator: Messoud Ashina, Professor, Professor of neurology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohammad Al-Mahdi Al-Karagholi, MD, PhD student, Principal investigator, Danish Headache Center
ClinicalTrials.gov Identifier:
NCT03212430
Other Study ID Numbers:
  • L-kynurenin H-16033148
First Posted:
Jul 11, 2017
Last Update Posted:
Jan 23, 2019
Last Verified:
Jan 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mohammad Al-Mahdi Al-Karagholi, MD, PhD student, Principal investigator, Danish Headache Center
L-kynurenine
Cerebral hemodynamic
Headache
Mohammad Al-Mahdi Al-Karagholi
Additional relevant MeSH terms:
Headache

Study Results

No Results Posted as of Jan 23, 2019