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

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ClinicalTrials.gov Identifier: NCT03212430
Recruitment Status : Recruiting
First Posted : July 11, 2017
Last Update Posted : July 11, 2017
Sponsor:
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 12, 24, and 36 nmol kg-1 min-1 over 20 min on 3 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)
Estimated 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
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache
U.S. FDA Resources


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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03212430


Contacts
Contact: Mohammad A Al-Karagholi, MD 00 45 31 19 16 47 mahdi.alkaragholi@gmail.com
Contact: Song Gu, MD 00 45 60 88 77 27 song60887727@gmail.com

Locations
Denmark
Rigshospitalet-Glostrup Recruiting
Glostrup, Nordre Ringvej 57, Denmark, 2600
Contact: Mohammad A Al-Karagholi, MD    00 45 31 19 16 47    mahdi.alkaragholi@gmail.com   
Contact: Song Guo, MD, PhD         
Sponsors and Collaborators
Danish Headache Center
Investigators
Principal Investigator: Messoud Ashina, Professor Professor of neurology

Responsible Party: Mohammad Al-Mahdi Al-Karagholi, MD, PhD student, Principal investigator, Danish Headache Center
ClinicalTrials.gov Identifier: NCT03212430     History of Changes
Other Study ID Numbers: L-kynurenin H-16033148
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017
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

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:
L-kynurenine
Cerebral hemodynamic
Headache
Mohammad Al-Mahdi Al-Karagholi

Additional relevant MeSH terms:
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms