PMID- 22316635
OWN - NLM
STAT- MEDLINE
DCOM- 20120910
LR  - 20131121
IS  - 1873-5126 (Electronic)
IS  - 1353-8020 (Linking)
VI  - 18
IP  - 4
DP  - 2012 May
TI  - Pardoprunox as adjunct therapy to levodopa in patients with Parkinson's disease 
      experiencing motor fluctuations: results of a double-blind, randomized, 
      placebo-controlled, trial.
PG  - 370-6
LID - 10.1016/j.parkreldis.2011.12.006 [doi]
AB  - AIMS: To determine the efficacy and safety of pardoprunox in levodopa-treated 
      patients with Parkinson's disease (PD) experiencing motor fluctuations. METHODS: 
      Patients were randomized to pardoprunox (up to 42 mg/day, n = 150) or placebo (n 
      = 144). Pardoprunox was titrated to an optimal dose over 7 weeks, followed by a 
      12-week stable dose period. The primary efficacy variable was the change from 
      baseline to study endpoint in total daily OFF time, based on patient diaries. 
      Secondary analyses included the change in ON time without troublesome 
      dyskinesias, UPDRS-ADL + Motor ON, UPDRS-ADL OFF and PDQ-39. Subgroup analyses 
      explored the impact of pardoprunox on dyskinesias (UPDRS items 32 + 33), 
      depression (Hospital Anxiety Depression Scale) and pain (Visual Analogue Scale). 
      RESULTS: Pardoprunox significantly reduced OFF time versus placebo (-1.62 h/day 
      versus -0.92 h/day, respectively, p = 0.0215). Compared to placebo, pardoprunox 
      improved ON time without troublesome dyskinesias (p = 0.0386), UPDRS-ADL + Motor 
      ON (p = 0.0003), and UPDRS-ADL OFF (p < 0.0001), while no significant difference 
      was observed on PDQ-39. A high drop-out rate due to adverse events (AEs) 
      (pardoprunox, 37%; placebo, 12%) suggested that the selected dose range may have 
      been too high, and/or titration was too rapid. CONCLUSIONS: Pardoprunox decreased 
      OFF time and increased ON time without troublesome dyskinesias in 
      levodopa-treated PD patients. The high drop-out rate at the selected doses 
      justifies the investigation of lower doses. The impact of pardoprunox on 
      dyskinesias and non-motor symptoms deserves further investigation.
CI  - Copyright (c) 2011 Elsevier Ltd. All rights reserved.
FAU - Rascol, O
AU  - Rascol O
AD  - Department of Clinical Pharmacology and Neurosciences, INSERM CIC9302 and UMR835, 
      University Hospital and University of Toulouse, 37 Allees Jules Guesde, 31000 
      Toulouse, France. rascol@cict.fr
FAU - Bronzova, J
AU  - Bronzova J
FAU - Hauser, R A
AU  - Hauser RA
FAU - Lang, A E
AU  - Lang AE
FAU - Sampaio, C
AU  - Sampaio C
FAU - Theeuwes, A
AU  - Theeuwes A
FAU - van de Witte, S V
AU  - van de Witte SV
LA  - eng
SI  - ClinicalTrials.gov/NCT00406588
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20120207
PL  - England
TA  - Parkinsonism Relat Disord
JT  - Parkinsonism & related disorders
JID - 9513583
RN  - 0 (Antiparkinson Agents)
RN  - 0 (Benzoxazoles)
RN  - 0 (Piperazines)
RN  - 46627O600J (Levodopa)
RN  - 5R72CHP32S (pardoprunox)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antiparkinson Agents/adverse effects
MH  - Benzoxazoles/*therapeutic use
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Dyskinesia, Drug-Induced/etiology/*prevention & control
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Levodopa/adverse effects
MH  - Male
MH  - Middle Aged
MH  - Pain Measurement
MH  - Parkinson Disease/*drug therapy/*physiopathology
MH  - Piperazines/*therapeutic use
MH  - Severity of Illness Index
MH  - Time Factors
MH  - Treatment Outcome
EDAT- 2012/02/10 06:00
MHDA- 2012/09/11 06:00
CRDT- 2012/02/10 06:00
PHST- 2011/07/18 00:00 [received]
PHST- 2011/11/28 00:00 [revised]
PHST- 2011/12/16 00:00 [accepted]
PHST- 2012/02/10 06:00 [entrez]
PHST- 2012/02/10 06:00 [pubmed]
PHST- 2012/09/11 06:00 [medline]
AID - S1353-8020(11)00431-7 [pii]
AID - 10.1016/j.parkreldis.2011.12.006 [doi]
PST - ppublish
SO  - Parkinsonism Relat Disord. 2012 May;18(4):370-6. doi: 
      10.1016/j.parkreldis.2011.12.006. Epub 2012 Feb 7.