drugset / Trial / NCT02448914
A Study to Compare Plasma Levels of Levodopa, Carbidopa and Entacapone After TRIGEL or Duodopa Infusion in PD Patients
RandomizedCrossoverOpen-labelTreatment
Summary
This study evaluates the continuous addition of entacapone to infused levodopa and carbidopa on the pharmacokinetic (PK) profile in patients with advanced Parkinson's disease (PD). All patients will receive both study drugs, i.e. TRIGEL (levodopa, carbidopa, and entacapone) and Duodopa (levodopa and carbidopa), in randomized order.
Timeline
- Start
- 2015-05
- Primary completion
- 2015-07
- Completion
- 2015-07
Outcome
Met primary endpoint
registry analysis (non-inferiority or equivalence test); TRIGEL vs Duodopa; p <0.0001; back-transformed ratio 1.382 (95% CI 1.264 to 1.511); ANCOVA NCT02448914 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carbidopa | Unknown | 5 mg/ml | Other |
| Subject | Entacapone | Small molecule | 20 mg/ml | Other |
| Subject | Levodopa | Unknown | 20 mg/ml | Other |