Neurological assessments
Conditions
Brief summary
Saccadic eye movements, Smooth pursuit eye movements, Adaptive tracking, N-Back (working memory load), Visual Analog Scales (VAS) Bond and Lader; Bowdle, Visual Verbal Learning Test (VVLT) memory testing, Change from baseline in MEP, Change from baseline TMS evoked potential (TEP) measured using single pulse and paired pulse TMS at ISIs 2, 15 and 100 ms, Body Sway
Detailed description
PK parameters of cannabidiol by non-compartmental analysis of the plasma concentration-time data, Treatment-emergent (serious) adverse events ((S)AEs) throughout the study at every study visit, Concomitant medication throughout the study at every study visit, Vital signs (Pulse Rate (bpm), Systolic blood pressure (mmHg), Diastolic blood pressure (mmHg)) as per assessment schedule
Interventions
DRUGAmygdalae Oleum
Raffinatum
DRUGClinican CBD 10% oil flavored
Sponsors
Centre for Human Drug Research
Eligibility
Sex/Gender
Male
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Saccadic eye movements, Smooth pursuit eye movements, Adaptive tracking, N-Back (working memory load), Visual Analog Scales (VAS) Bond and Lader; Bowdle, Visual Verbal Learning Test (VVLT) memory testing, Change from baseline in MEP, Change from baseline TMS evoked potential (TEP) measured using single pulse and paired pulse TMS at ISIs 2, 15 and 100 ms, Body Sway | — |
Secondary
| Measure | Time frame |
|---|---|
| PK parameters of cannabidiol by non-compartmental analysis of the plasma concentration-time data, Treatment-emergent (serious) adverse events ((S)AEs) throughout the study at every study visit, Concomitant medication throughout the study at every study visit, Vital signs (Pulse Rate (bpm), Systolic blood pressure (mmHg), Diastolic blood pressure (mmHg)) as per assessment schedule | — |
Countries
Netherlands
Outcome results
None listed