and stroke-like episodes (MELAS), lactic acidosis, Mitochondrial encephalomyopathy
Conditions
Brief summary
Incidence of treatment-emergent adverse events (TEAEs)
Detailed description
Vital sign measurements, ECG assessments, clinical laboratory tests, and C-SSRS responses at each scheduled timepoint, DEXA hip and lumbar spine BMD at each scheduled timepoint, Concentrations of CTX and P1NP at each scheduled timepoint, Incidence of SLE. Time to first SLE from Day 1, NMDAS scores at each scheduled timepoint, Concentrations of lactate, GDF-15, FGF-21, B2M, serum amyloid P component, TNFR-2, vWF, ICAM-1, NfL, and VCAM-1 at each scheduled timepoint, CGI-C overall MELAS scale score at each scheduled timepoint, eGFR and UACR at each scheduled timepoint, HbA1c level at each scheduled timepoint, Concentrations of troponin I, NT-proBNP, and creatine kinase (CK)-MB at each scheduled timepoint, Exploratory pharmacokinetics: Concentrations of zagociguat at each scheduled time point
Interventions
DRUGzagociguat 15 mg
Sponsors
Tisento Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) | — |
Secondary
| Measure | Time frame |
|---|---|
| Vital sign measurements, ECG assessments, clinical laboratory tests, and C-SSRS responses at each scheduled timepoint, DEXA hip and lumbar spine BMD at each scheduled timepoint, Concentrations of CTX and P1NP at each scheduled timepoint, Incidence of SLE. Time to first SLE from Day 1, NMDAS scores at each scheduled timepoint, Concentrations of lactate, GDF-15, FGF-21, B2M, serum amyloid P component, TNFR-2, vWF, ICAM-1, NfL, and VCAM-1 at each scheduled timepoint, CGI-C overall MELAS scale score at each scheduled timepoint, eGFR and UACR at each scheduled timepoint, HbA1c level at each scheduled timepoint, Concentrations of troponin I, NT-proBNP, and creatine kinase (CK)-MB at each scheduled timepoint, Exploratory pharmacokinetics: Concentrations of zagociguat at each scheduled time point | — |
Countries
Germany, Italy
Outcome results
None listed