3 and Huntington's disease, Spinocerebellar ataxia types 1
Conditions
Brief summary
Incidence and dose relationships of treatment-related: o AEs, o SAEs, o AESI o Severe events (NCI- CTCAE Grade 3 or higher)., Changes in clinical safety parameters including physical and neurological examinations, vital signs, body weight, ECG, cardiac monitoring, suicidal ideation and behaviour risk monitoring by the C-SSRS, and review of structural MRI scans, Changes in laboratory safety parameters in blood (haematology, haemostasis, and clinical chemistry), CSF (cell counts, protein, and glucose), and urine (urinalysis), Adverse changes in clinical status based on exploratory clinical, biochemical and neuroimaging assessments
Detailed description
The CSF concentration-time profile of VO659, including the derived PK parameter of elimination t1/2, if possible, The plasma concentration-time profile of VO659, including the derived PK parameters such as the area under the curve, peak plasma concentration t1/2.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and dose relationships of treatment-related: o AEs, o SAEs, o AESI o Severe events (NCI- CTCAE Grade 3 or higher)., Changes in clinical safety parameters including physical and neurological examinations, vital signs, body weight, ECG, cardiac monitoring, suicidal ideation and behaviour risk monitoring by the C-SSRS, and review of structural MRI scans, Changes in laboratory safety parameters in blood (haematology, haemostasis, and clinical chemistry), CSF (cell counts, protein, and glucose), and urine (urinalysis), Adverse changes in clinical status based on exploratory clinical, biochemical and neuroimaging assessments | — |
Secondary
| Measure | Time frame |
|---|---|
| The CSF concentration-time profile of VO659, including the derived PK parameter of elimination t1/2, if possible, The plasma concentration-time profile of VO659, including the derived PK parameters such as the area under the curve, peak plasma concentration t1/2. | — |
Countries
Denmark, France, Germany, Netherlands