drugset / Trial / NCT01883505
A Safety, Tolerability and Levodopa Pharmacokinetics Study of Repeated ND0612 in Parkinson's Disease Patients
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a randomized, placebo-controlled, double-blind, 2-period study evaluating the safety and pharmacokinetics (PK) of ND0612 in Parkinson's disease (PD) patients on an optimized oral levodopa (LD) regimen and experiencing ≥2 h/day of OFF time. Safety and tolerability, PK profile, pump usability, and the potential clinical effect of ND0612 will be explored in subjects with PD and motor fluctuations.
Timeline
- Start
- 2014-01-06
- Primary completion
- 2015-04-26
- Completion
- 2015-04-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Entacapone | Small molecule | 200 mg | Oral |
| Subject | ND0612 | Unknown | — | Subcutaneous |