Vanishing White Matter disease
Conditions
Brief summary
AEs and SAEs during the Safety Evaluation Period, Vital signs, ECGs, clinical laboratory tests, and suicidality assessments during the Safety Evaluation Period, Plasma concentrations of A-1684909 at pre-specified visits from Baseline up to Week 96 for all cohorts, CSF concentrations of A-1684909 at Week 12, Week 48, and Week 96 for all cohorts, Plasma PK parameters of A-1684909 following dosing at V4 (Study Day 14) for Cohorts 1 and 1b: Cmax; Tmax; AUC0-24h; Ctrough; and t1/2, functional
Detailed description
AEs and SAEs at last visit (Week 197), Vital signs, ECGs, clinical laboratory tests and suicudality up to last vist (Week 197)
Interventions
DRUGABBV-CLS-7262
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AEs and SAEs during the Safety Evaluation Period, Vital signs, ECGs, clinical laboratory tests, and suicidality assessments during the Safety Evaluation Period, Plasma concentrations of A-1684909 at pre-specified visits from Baseline up to Week 96 for all cohorts, CSF concentrations of A-1684909 at Week 12, Week 48, and Week 96 for all cohorts, Plasma PK parameters of A-1684909 following dosing at V4 (Study Day 14) for Cohorts 1 and 1b: Cmax; Tmax; AUC0-24h; Ctrough; and t1/2, functional | — |
Secondary
| Measure | Time frame |
|---|---|
| AEs and SAEs at last visit (Week 197), Vital signs, ECGs, clinical laboratory tests and suicudality up to last vist (Week 197) | — |
Countries
Netherlands
Outcome results
None listed