Conditions: Parkinson's Disease
Keywords: Parkinson's
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 27
Healthy volunteers: no

Brief summary:
This study evaluated the pharmacokinetics, motor effects, and assessed the safety of IPX066 compared with an immediate-release cabridopa-levodopa formulation in subjects with advanced Parkinson's disease.

Detailed description:
This was a randomized, multicenter, open-label, single and multiple oral dose, two-treatment, two-period, crossover study in LD-experienced subjects with Parkinson's disease (PD). Subjects received 7 days of one treatment (IPX066 or IR CD-LD) followed by an approximate 7-day washout period followed by another 7 days of the other treatment (IR CD-LD or IPX066). During the approximate 7-day washout period, subjects took their prestudy CD-LD regimen. Pharmacokinetic and efficacy/pharmacodynamic measurements were done on Days 1 and 8. Safety measures (electrocardiograms \[ECGs\], clinical laboratory tests, vital signs, adverse events \[AEs\], and concomitant medications) were evaluated over the course of the study.

Arms:
arm 1: Treatment Period 1:

IPX066 - 7 days; Washout Period - 7 days;

Treatment Period 2:

IR CD-LD- 7 days arm 2: Treatment Period 1:

IR CD-LD - 7 days; Washout period - 7 days;

Treatment Period 2:

IPX066- 7 days

Interventions: intervention 1: IPX066 intervention 2: IR CD-LD
Intervention descriptions: intervention 1: experimental drug product: extended-release carbidopa-levodopa capsules intervention 2: active comparator: immediate-release carbidopa-levodopa capsules

Protocol document: