A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa

Summary

The purpose of this study is to achieve approval for the use of carbidopa/levodopa/entacapone in early Parkinson's disease (PD) by demonstrating that when used as initial levodopa therapy in early PD, carbidopa/levodopa/entacapone provides significantly greater symptomatic benefit than immediate release carbidopa/levodopa administered at the same levodopa dosage level of 100 mg three times a day (t.i.d.).

Timeline

Start

2005-08

Primary completion

2007-09

Completion

2007-09

Outcome

Met primary endpoint

paper prespecified primary outcome measure) was 1.7 (standard error = 0.84) points favoring LCE (P = 0.045). PMID 19058133 ↗

release “statistically significant positive result for the primary endpoint was obtained in the Phase 3 clinical FIRST- STEP study” orionpharma.com ↗

Publications

• Hauser RA, Panisset M, Abbruzzese G, Mancione L, Dronamraju N, Kakarieka A; FIRST-STEP Study Group. Double-blind trial of levodopa/carbidopa/entacapone versus levodopa/carbidopa in early Parkinson's disease. Mov Disord. 2009 Mar 15;24(4):541-50. doi: 10.1002/mds.22343.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Carbidopa	Unknown	25 mg	—
Subject	Entacapone	Small molecule	200 mg	—
Subject	Levodopa	Unknown	100 mg	—

Indications