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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03496870 | A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of Opicapone in Subjects With Parkinson's Disease Taking Levodopa. | PHASE1 | COMPLETED | 16 | — | — | Feb 8, 2018 | Jul 2, 2018 | Mar 22, 2019 | 3 | United States |
Area under the plasma concentration versus time curve from 0 to 24 hours for analytes with quantifiable concentrations at 24 hours postdose
Area under the plasma concentration versus time curve from 0 hour to the time of the last measurable concentration for analytes below the limit of quantification at 24 hours postdose
Maximum plasma concentration
Time to maximum plasma concentration
Area under the plasma concentration versus time curve from 0 hours to time before next levodopa dose
Maximum plasma concentration
| Arm | Type | Description |
|---|---|---|
| Opicapone once daily with Carbidopa/Levodopa | EXPERIMENTAL | Opicapone administered once daily for 14 days; carbidopa/levodopa administered at set frequency on Study Days 1, 2 \& 15 |
| Name | Type | Description |
|---|---|---|
| Opicapone | DRUG | catechol-O-methyltransferase (COMT) inhibitor |
| Carbidopa Levodopa | DRUG | Levodopa: dopamine precursor Carbidopa: DOPA decarboxylase inhibitor |
Inclusion Criteria: 1. Have a clinical diagnosis of idiopathic Parkinson's Disease (PD) for at least 3 years with clear improvement with levodopa treatment 2. Be at a stable dose of maintenance medication(s) for PD, including stable doses of CD/LD 3. Subjects of childbearing potential who do not pr...