drugset / Trial / NCT02615873
A Study of AP-CD/LD in Fluctuating Parkinson's Disease Patients Who Completed IN 11 004
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to allow evaluation of long-term clinical effect and safety outcome of treatment with AP-CD/LD, as well as to allow patients to benefit from extended treatment duration with AP-CD/LD after they have successfully completed the Phase 3 core study IN 11 004 ('core study', a phase III, multicenter, randomized, double-blind, double-dummy, active-controlled Phase 3 study to assess the safety and efficacy of AP CD/LD versus IR CD/LD in fluctuating PD patients).
Timeline
- Start
- 2016-07
- Primary completion
- 2019-12
- Completion
- 2019-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carbidopa | Unknown | 50 mg | — |
| Subject | Levodopa | Small molecule | 400 mg | — |
| Subject | Levodopa | Small molecule | 500 mg | — |