Conditions: Parkinson's Disease
Keywords: Parkinson's Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 471
Healthy volunteers: no

Brief summary:
This is a study to evaluate the safety and efficacy of IPX066 in advanced Parkinson's disease.

Detailed description:
A randomized, double-blind, active-control, parallel-group 13-week comparison of IPX066 versus regular carbidopa-levodopa (CD-LD). Prior to randomization, subjects on a stable regular LD regimen will enter a 3-week dose-adjustment period for IR CD-LD, followed by a 6-week dose-conversion period to IPX066.

Arms:
arm 1: Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IPX066. arm 2: Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IR CD-LD (active comparator).

Interventions: intervention 1: IPX066 intervention 2: IR CD-LD
Intervention descriptions: intervention 1: extended-release carbidopa-levodopa capsules intervention 2: immediate-release carbidopa-levodopa tablets

Protocol document: