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Aix-en-Provence, France

Viallet F.,Center Hospitalier du Pays dAix | Pitel S.,Qualissima | Lancrenon S.,Sylia Statistics | Blin O.,Marseille University Hospital Center
Current Medical Research and Opinion | Year: 2013

Objective: Rasagiline is a second-generation, irreversible MAO-B inhibitor (MAOB-I) previously shown to be efficacious and well-tolerated compared to placebo in the treatment of early Parkinson's disease (PD). ACTOR (ACceptabilité TOlérance Rasagiline) was a 15-week, multi-center, randomized, double-blind study aimed to assess the safety and tolerability of rasagiline compared to the dopaminergic agonist pramipexole in the treatment of early PD. Methods: Patients with early, untreated idiopathic PD were randomized to receive 1mg rasagiline (n=53) or 1.5mg pramipexole (n=56) daily. The primary outcome was the number of patients experiencing a 'clinically important adverse event' (classified as a serious adverse event, an event leading to withdrawal or severe according to the patient). Safety outcomes were evaluated by the investigator and the patient. Analysis of the primary criterion was a comparative analysis using the chi-squared test. The Wilcoxon Mann-Whitney test was conducted to test the severity of patient-reported adverse events. Other tests performed include a covariance analysis and Student's t-tests. Results: Mean disease duration was 3.4 months, and mean age was 62.6 years. Of patients taking pramipexole, 44.6% reported at least one 'clinically important' adverse event compared to 32.1% of patients taking rasagiline; non-inferiority of rasagiline was reached, with a difference in proportions of-12.6% [confidence interval of-27.8%; 2.6%]. There were no significant differences in clinical effectiveness between the treatments, measured by clinical and patient global impression of improvement (CGI-I, PGI-I) and PDQ-8 scales. A significant decrease in the incidence of gastrointestinal symptoms (p=0.015) and sleep disorders (p=0.027) was reported by physicians in the rasagiline group compared to the pramipexole group; the propensity to sleepiness improved significantly in the rasagiline group (p=0.020), and worsened in the pramipexole group (p=0.042). Limitations: Limitations of this study include the limited sample size due to the lower than anticipated recruitment and the accidental inclusion of a patient who had taken contraindicated medication. Conclusions: In this study, the safety profile of rasagiline had clinically favorable differences in gastrointestinal and sleep adverse events compared to pramipexole, whilst showing comparable clinician and patient-rated clinical effectiveness as a monotherapy for the treatment of early idiopathic PD. © 2013 Informa UK Ltd All rights reserved. Source

Pautier P.,Institute Gustave Roussy | Floquet A.,Institute Bergonie | Gladieff L.,Institute Claudius Regaud | Bompas E.,Center Rene Gauducheau | And 18 more authors.
Annals of Oncology | Year: 2013

Background: There is no proven benefit of adjuvant treatment of uterine sarcoma (US). SARCGYN phase III study compared adjuvant polychemotherapy followed by pelvic radiotherapy (RT) (arm A) versus RT alone (arm B) conducted to detect an increase ≥ 20% of 3-year PFS. Methods: Patients with FIGO stage ≤ III US, physiological age ≤ 65 years; chemotherapy: four cycles of doxorubicin 50 mg/m2 d1, ifosfamide 3 g/m2/day d1-2, cisplatin 75 mg/m2 d3, (API) + G-CSF q 3 weeks. Study was stopped because of lack of recruitment. Results: Eighty-one patients were included: 39 in arm A and 42 in arm B; 52 stage I, 16 stage II, 13 stage III; 53 leiomyosarcomas, 9 undifferenciated sarcomas, 19 carcinosarcomas. Gr 3-4 toxicity during API (/37 patients): thrombopenia (76%), febrile neutropenia (22%) with two toxic deaths; renal gr 3 (1 patient). After a median follow-up of 4.3 years, 41/81 patients recurred, 15 in arm A, 26 in arm B. The 3 years DFS is 55% in arm A, 41% in arm B (P = 0.048). The 3-year overall survival (OS) is 81% in arm A and 69% in arm B (P = 0.41). Conclusion: API adjuvant CT statistically increases the 3 year-DFS of patients with US. © The Author 2012. Source

Letanneux A.,Aix - Marseille University | Danna J.,Aix - Marseille University | Velay J.-L.,Aix - Marseille University | Viallet F.,Aix - Marseille University | And 2 more authors.
Movement Disorders | Year: 2014

Micrographia, an abnormal reduction in writing size, is a specific behavioral deficit associated with Parkinson's disease (PD). In recent years, the availability of graphic tablets has made it possible to study micrographia in unprecedented detail. Consequently, a growing number of studies show that PD patients also exhibit impaired handwriting kinematics. Is micrographia still the most characteristic feature of PD-related handwriting deficits? To answer this question, we identified studies that investigated handwriting in PD, either with conventional pencil-and-paper measures or with graphic tablets, and we reported their findings on key spatiotemporal and kinematic variables. We found that kinematic variables (velocity, fluency) differentiate better between control participants and PD patients, and between off- and on-treatment PD patients, than the traditional measure of static writing size. Although reduced writing size is an important feature of PD handwriting, the deficit is not restricted to micrographia stricto sensu. Therefore, we propose the term PD dysgraphia, which encompasses all deficits characteristic of Parkinsonian handwriting. We conclude that the computerized analysis of handwriting movements is a simple and useful tool that can contribute to both diagnosis and follow-up of PD. © 2014 International Parkinson and Movement Disorder Society . Source

Moreau C.,University of Lille Nord de France | Pennel-Ployart O.,University of Lille Nord de France | Pinto S.,CNRS Speech and Language Laboratory | Plachez A.,University of Lille Nord de France | And 5 more authors.
Movement Disorders | Year: 2011

Background: Parkinsonian dysarthria (as typically characterized by hypophonia, monotony of pitch, and rhythm abnormalities) is often accompanied by gait disturbances. The long-term effect of subthalamic nucleus deep brain stimulation (STN DBS) on dysarthria remains unclear. Methods: Given STN DBS's known improvement of gait disorders, we analyzed speech intelligibility and aerodynamic and acoustic parameters in 11 advanced PD patients in three double-blind, randomized conditions: "defined Off," 60 Hz STN DBS and 130 Hz STN DBS. Results: An improvement in aerodynamic speech parameters during 60 Hz STN DBS was accompanied by significant clinical benefit. Conclusions: Chronic treatment with low-frequency STN DBS may have a beneficial impact on dysarthropneumophonia, even in advanced PD patients. © 2011 Movement Disorder Society. Source

Payan C.A.M.,University Pierre and Marie Curie | Viallet F.,Center Hospitalier du Pays dAix | Landwehrmeyer B.G.,University of Ulm | Bonnet A.-M.,French Institute of Health and Medical Research | And 10 more authors.
PLoS ONE | Year: 2011

Background: The Natural History and Neuroprotection in Parkinson Plus Syndromes (NNIPPS) study was a large phase III randomized placebo-controlled trial of riluzole in Progressive Supranuclear Palsy (PSP, n = 362) and Multiple System Atrophy (MSA, n = 398). To assess disease severity and progression, we constructed and validated a new clinical rating scale as an ancillary study. Methods and Findings: Patients were assessed at entry and 6-montly for up to 3 years. Evaluation of the scale's psychometric properties included reliability (n = 116), validity (n = 760), and responsiveness (n = 642). Among the 85 items of the initial scale, factor analysis revealed 83 items contributing to 15 clinically relevant dimensions, including Activity of daily Living/Mobility, Axial bradykinesia, Limb bradykinesia, Rigidity, Oculomotor, Cerebellar, Bulbar/Pseudo-bulbar, Mental, Orthostatic, Urinary, Limb dystonia, Axial dystonia, Pyramidal, Myoclonus and Tremor. All but the Pyramidal dimension demonstrated good internal consistency (Cronbach α≥0.70). Inter-rater reliability was high for the total score (Intra-class coefficient = 0.94) and 9 dimensions (Intra-class coefficient = 0.80-0.93), and moderate (Intra-class coefficient = 0.54-0.77) for 6. Correlations of the total score with other clinical measures of severity were good (rho≥0.70). The total score was significantly and linearly related to survival (p<0.0001). Responsiveness expressed as the Standardized Response Mean was high for the total score slope of change (SRM = 1.10), though higher in PSP (SRM = 1.25) than in MSA (SRM = 1.0), indicating a more rapid progression of PSP. The slope of change was constant with increasing disease severity demonstrating good linearity of the scale throughout disease stages. Although MSA and PSP differed quantitatively on the total score at entry and on rate of progression, the relative contribution of clinical dimensions to overall severity and progression was similar. Conclusions: The NNIPPS-PPS has suitable validity, is reliable and sensitive, and therefore is appropriate for use in clinical studies with PSP or MSA. Trial Registration: ClinicalTrials.gov NCT00211224. © 2011 Payan et al. Source

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