Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy

Phase 3 Completed 747 enrolled Novartis Pharmaceuticals Orion Corporation, Orion Pharma · collab

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The CELC200A2401 study has been designed in order to evaluate the hypothesis that administering the combination carbidopa/levodopa/entacapone at the time that levodopa therapy is initiated results in a decrease in the risk of the development of motor complications for patients with Parkinson's disease.

Timeline

Start: 2004-09
Primary completion: 2008-11
Completion: 2008-11

Outcome

Sources disagree · no verdict is set; each source's reading is shown below

paper Initiating L-dopa therapy with LCE failed to delay the time of onset or reduce the frequency of dyskinesia compared to LC. reads as missed primary endpoint PMID 20582993 ↗

release “Orion disclosed the positive primary endpoint in its stock exchange release on 24 January 2008.” reads as met primary endpoint orionpharma.com ↗

Publications

Stocchi F, Rascol O, Kieburtz K, Poewe W, Jankovic J, Tolosa E, Barone P, Lang AE, Olanow CW. Initiating levodopa/carbidopa therapy with and without entacapone in early Parkinson disease: the STRIDE-PD study. Ann Neurol. 2010 Jul;68(1):18-27. doi: 10.1002/ana.22060.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Entacapone	Small molecule	200 mg	Oral
Comparator	Carbidopa	Unknown	12.5 mg	Oral
Comparator	Carbidopa	Unknown	25 mg	Oral
Comparator	Levodopa	Unknown	50 mg	Oral
Comparator	Levodopa	Unknown	100 mg	Oral