Treatment of End-of-Dose Wearing-Off in Parkinson’s Disease: Stalevo® (Levodopa/Carbidopa/Entacapone) and Levodopa/DDCI Given in Combination with Comtess®/Comtan® (Entacapone) Provide Equivalent Improvements in Symptom Control Superior to That of Traditional Levodopa/DDCI Treatment

Vol. 53, No. 4, 2005

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Original Paper

Treatment of End-of-Dose Wearing-Off in Parkinson's Disease: Stalevo^® (Levodopa/Carbidopa/Entacapone) and Levodopa/DDCI Given in Combination with Comtess^®/Comtan^® (Entacapone) Provide Equivalent Improvements in Symptom Control Superior to That of Traditional Levodopa/DDCI Treatment
D.J. Brooks^a, Y. Agid^b, K. Eggert^c, H. Widner^d, K. Østergaard^e, A. Holopainen^f, and the TC-INIT Study Group

^aMRC Clinical Sciences Centre and Division of Neuroscience, Faculty of Medicine, Imperial College, Hammersmith Hospital, London, UK;
^bHopital de la Salpétrière, Paris, France;
^cDepartment of Neurology, Philipps University, Marburg, Germany;
^dDepartment of Neurology, Lund University Hospital, Lund, Sweden;
^eAarhus Kommunehospital, Neurologisk Afdeling F, Aarhus, Denmark;
^fOrion Corporation, Orion Pharma, Espoo, Finland

Address of Corresponding Author

Eur Neurol 2005;53:197-202 (DOI: 10.1159/000086479)

Key Words

Parkinson's disease
Stalevo^®
Levodopa
Dopa-decarboxylase inhibitor
Catechol-O-methyltransferase inhibition
Wearing-off

Abstract

The aim of this study was to evaluate the efficacy of the new optimised levodopa, Stalevo^® (levodopa, carbidopa and entacapone) in patients with Parkinson's disease experiencing end-of-dose wearing-off. Treatment with Stalevo was compared to treatment with traditional immediate-release levodopa and dopa-decarboxylase inhibitor (DDCI) formulations along with adjunct entacapone (Comtess^®/Comtan^®). A European, open, parallel-group, active treatment-controlled phase IIIb study evaluating 176 patients randomised to switch from their current regimen of levodopa/DDCI to either an equivalent dose of Stalevo or levodopa/DDCI plus entacapone. After 6 weeks, treatments were assessed using the Clinical Global Impression of Change, the Unified Parkinson's Disease Rating Scale and a Motor Fluctuations Questionnaire. Over 70% of patients in both the Stalevo and adjunct entacapone arms felt that they were clinically improved and over 80% experienced a reduction in fluctuations. Although there was no significant difference between Stalevo and levodopa/DDCI plus entacapone with regard to motor improvement and side effects, 81% of patients stated that they preferred treatment with Stalevo compared with taking two separate tablets (i.e. levodopa/DDCI and entacapone). Stalevo was well tolerated and safe when substituted for levodopa DDCI preparations.

Author Contacts

Prof. David Brooks, MD, DSc, FRCP, FMedSci
Cyclotron Building, Hammersmith Hospital
Ducane Road
London W12 0NN (UK)
Tel. +44 208 383 3172, Fax +44 208 383 1783, E-Mail david.brooks@csc.mrc.ac.uk

Article Information

Principle Investigators and Study Coordinators of the TC-INIT Study Group are listed in the appendix.

Received: February 9, 2005
Accepted: April 13, 2005
Published online: June 20, 2005
Number of Print Pages : 6
Number of Figures : 2, Number of Tables : 2, Number of References : 19

Medline Abstract (ID 15970632)

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