Comparison of IPX054, IR Carbidopa-Levodopa, and CR Carbidopa-Levodopa in Subjects With Parkinson's Disease

PHASE2CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

January 31, 2006

Primary Completion Date

December 31, 2007

Study Completion Date

December 31, 2007

Conditions
Idiopathic Parkinson's Disease
Interventions
DRUG

IPX054 200 mg

IPX054 tablet containing 50 mg carbidopa and 200 mg levodopa

DRUG

IPX054 250 mg

IPX054 tablet containing 62.5 mg carbidopa and 250 mg levodopa

DRUG

CD-LD IR

Active comparator containing 25 mg carbidopa and 100 mg levodopa

DRUG

CD-LD CR

Active comparator containing 50 mg carbidopa and 200 mg levodopa

DRUG

IPX054 200 mg Placebo

Placebo to match IPX054 200 mg

DRUG

IPX054 250 mg Placebo

Placebo to match IPX054 250 mg

DRUG

CD-LD IR Placebo

Placebo to match CD-LD IR

DRUG

CD-LD CR Placebo

Placebo to match CD-LD CR

Trial Locations (2)

48025

Quest Research Institute, Bingham Farms

97239

Oregon Health Sciences University - Parkinson's Center of Oregon, Portland

Sponsors
All Listed Sponsors
lead

Impax Laboratories, LLC

INDUSTRY

NCT00279825 - Comparison of IPX054, IR Carbidopa-Levodopa, and CR Carbidopa-Levodopa in Subjects With Parkinson's Disease | Biotech Hunter | Biotech Hunter