Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02459886 | Single-Ascending Dose Study of BIIB054 in Healthy Participants and Early Parkinson's Disease | PHASE1 | COMPLETED | 66 | — | — | Jul 1, 2015 | Nov 20, 2017 | Aug 8, 2019 | 9 | United States |
After a range of single BIIB054 doses administered as a single IV infusion in healthy participants and participants with early Parkinson's Disease, clinical laboratory test data, vital signs, neurological and physical examination findings, 12-lead electrocardiogram (ECG) data, and brain magnetic resonance imaging (MRI) findings will be used in the evaluation of AEs/SAEs.
The Columbia Suicide Severity Rating Scale, or C-SSRS, is a suicidal ideation rating scale created by researchers at Columbia University to evaluate suicidality.
The Montreal Cognitive Assessment MoCA is a brief cognitive screening tool for Mild Cognitive Impairment.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Single intravenous (IV) low dose infusion with staggered participant dosing |
| Cohort 2 | EXPERIMENTAL | Single IV ascending dose infusion with staggered participant dosing |
| Cohort 3 | EXPERIMENTAL | Single IV ascending dose infusion with staggered participant dosing |
| Cohort 4 | EXPERIMENTAL | Single IV ascending dose infusion with staggered participant dosing |
| Cohort 5 | EXPERIMENTAL | Single IV ascending dose infusion with staggered participant dosing |
| Cohort 6 | EXPERIMENTAL | Single IV ascending dose infusion with staggered participant dosing |
| Cohort 7 | EXPERIMENTAL | Single IV ascending dose infusion with staggered participant dosing |
| Name | Type | Description |
|---|---|---|
| BIIB054 | DRUG | IV infusion |
| Placebo | DRUG | IV infusion |
Key Inclusion Criteria: 1. All women of childbearing potential and all men must practice effective contraception during the study and for 6 months after their last dose of study treatment. 2. Must have a body mass index from 19 to 32 kg/m2, inclusive. 3. Must be in good health as determined by the ...