Conditions: Parkinson's Disease
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 110
Healthy volunteers: no

Brief summary:
This is a study to compare the efficacy of IPX066 and CLE in subjects with advanced Parkinson's disease.

Detailed description:
This is a randomized, double-blind, double-dummy, 2 treatment, 2-period crossover study followed by an open-label extension study period.

Arms:
arm 1: Dose conversion from CLE to IPX066, IPX066 (Part 1 Period 1), Open-label IPX066, CLE (Part 1 Period 2), OLE (Part 2) arm 2: Dose conversion from CLE to IPX066, CLE (Part 1 Period 1), Open-label IPX066, IPX066 (Part 1 Period 2), OLE (Part 2)

Interventions: intervention 1: IPX066 intervention 2: CLE
Intervention descriptions: intervention 1: experimental product intervention 2: active comparator

Protocol document: