The Parkinson-control study: A 1-year randomize, double-blind trial comapring piribedil (150 mg/day) with bromocriptine (25 mg/day) in early combination with levodopa in Parkinson's disease

Alexandre Castro-Caldas, Paul Delwaide, Wolfgang Jost, Marcelo Merello, Adrian Williams, Paolo Lamberti, Miguel Aguilar, Susanna Del Signore, Pierre Cesaro, J. Bueri, M. M. Fernandez Pardal, S. Garcia, F. Micheli, P. Cras, F. Piessens, P. Tack, P. Bourgeois, N. De Klippel, M. Van Orshoven, M. DupuisM. Cornette, R. Benrabah, A. Blanc, J. M. Blard, J. P. Borsotti, C. Bossu, P. Contis, A. Danielli, R. Decombe, P. Der Agopian, B. Dubois, B. Dupuy, J. C. Getenet, P. Girard-Madoux, P. Gras, O. Guard, L. Laverhne, J. Maupetit, A. Mazingue, M. Merienne, G. Mick, B. Mihout, P. Péran, P. Prince, T. Soisson, C. Tranchant, H. Vespignani, J. Vaunaize, M. Verin, F. Viallet, A. R. Berg-Mantkowski, T. Gasser, J. Glass, F. Hoffman, U. Polzer, F. Piccoli, A. Bastos Lima, C. Costa, L. Cunha, J. Ferreira, M. Rosa, M. Calopa, A. Castro, J. Chacon, E. Diez Tejedor, S. Gimenez Roldan, R. Gonzalez Maldonado, J. Kulievsky, G. Linazasoro, J. Lopez del Val, L. Miquel, L. Vela Desojo, J. Vaamonde, P. Critchley, M. Steiger

Research output: Contribution to journalArticle

Abstract

Dopamine agonists have been recommended as early treatment Parkinson's disease (PD), alone or combined with levodopa. Piribedil is a non-ergot selective D2/D3 agonist with α2, antagonist properties shown to be effective in the treatment of PD. This 12-month international, randomized, double-blind trial aimed to assess the efficacy of piribedil 150 mg versus bromocriptine 25 mg, in early combination with levodopa in Stage I to III PD patients. Motor efficacy was assessed using the Unified Parkinson's Disease Rating Scale (UPDRS III, Items 18-31) as improvement from baseline. Response rate was defined as a 30% improvement. Among the 425 randomly assigned patients, 178 were also included in a substudy on cognitive follow-up evaluated by a dysexecutive syndrome oriented battery. A relevant improvement in UPDRS III over the 12-month study duration was observed both in the piribedil and bromocriptine groups (-7.9 ± 9.7 points from baseline versus -8.0 ± 9.5; not significant [n.s.]) with a response rate of 58.4% and 55.3% (n.s.), respectively. Piribedil and bromocriptine resulted in similar improvement on all UPDRS III subscores. Piribedil patients required less levodopa dose increase than those on bromocriptine. Cognitive performance remained generally unchanged in both groups, with a significant effect of piribedil limited to the Wisconsin Card Sorting Test. An overall good tolerability of piribedil was observed. Early combination of piribedil 150 mg with levodopa resulted in significant long-term improvement of all motor symptoms in PD patients insufficiently controlled by levodopa alone. Taking into account both efficacy and acceptability in the long-term, piribedil proved in this bromocriptine controlled study to be an effective and safe treatment for PD.

Original languageEnglish
Pages (from-to)500-509
Number of pages10
JournalMovement Disorders
Volume21
Issue number4
DOIs
Publication statusPublished - Apr 2006

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Keywords

  • Bromocriptine
  • Dopamine agonists
  • Levodopa
  • Parkinsons's disease
  • Piribedil

ASJC Scopus subject areas

  • Clinical Neurology
  • Neuroscience(all)

Cite this

Castro-Caldas, A., Delwaide, P., Jost, W., Merello, M., Williams, A., Lamberti, P., Aguilar, M., Del Signore, S., Cesaro, P., Bueri, J., Fernandez Pardal, M. M., Garcia, S., Micheli, F., Cras, P., Piessens, F., Tack, P., Bourgeois, P., De Klippel, N., Van Orshoven, M., ... Steiger, M. (2006). The Parkinson-control study: A 1-year randomize, double-blind trial comapring piribedil (150 mg/day) with bromocriptine (25 mg/day) in early combination with levodopa in Parkinson's disease. Movement Disorders, 21(4), 500-509. https://doi.org/10.1002/mds.20750