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To measure the cerebral hemodynamic effect of L-kynurenine.
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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-kynurenine | Drug | intravenous infusion of L-kynurenine to healthy individuals. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Messoud Ashina, Professor | Professor of neurology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet-Glostrup | Glostrup Municipality | Nordre Ringvej 57 | 2600 | Denmark |
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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| ID | Term |
|---|---|
| D006261 | Headache |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007737 | Kynurenine |
| ID | Term |
|---|---|
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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Pilot, Open label
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