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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03212430
Recruitment Status : Completed
First Posted : July 11, 2017
Last Update Posted : January 23, 2019
Information provided by (Responsible Party):
Mohammad Al-Mahdi Al-Karagholi, Danish Headache Center

Brief Summary:
To measure the cerebral hemodynamic effect of L-kynurenine.

Condition or disease Intervention/treatment Phase
Headache Drug: L-kynurenine 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Pilot, 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 : March 1, 2017
Actual Primary Completion Date : January 20, 2019
Actual Study Completion Date : January 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

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

Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03212430

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Glostrup, Nordre Ringvej 57, Denmark, 2600
Sponsors and Collaborators
Danish Headache Center
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Principal Investigator: Messoud Ashina, Professor Professor of neurology
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Responsible Party: Mohammad Al-Mahdi Al-Karagholi, MD, PhD student, Principal investigator, Danish Headache Center Identifier: NCT03212430    
Other Study ID Numbers: L-kynurenin H-16033148
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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

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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, Danish Headache Center:
Cerebral hemodynamic
Mohammad Al-Mahdi Al-Karagholi
Additional relevant MeSH terms:
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Neurologic Manifestations
Signs and Symptoms