Headache
Conditions
Keywords
L-kynurenine, Cerebral hemodynamic, Headache, Mohammad Al-Mahdi Al-Karagholi
Brief summary
To measure the cerebral hemodynamic effect of 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.
Interventions
DRUGL-kynurenine
intravenous infusion of L-kynurenine to healthy individuals.
Sponsors
Danish Headache Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
Pilot, Open label
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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. |
Countries
Denmark
Outcome results
None listed