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A multi-centre, randomized, double-blind, placebo-controlled, parallel-group, multiple oral dose study to assess the efficacy, safety and tolerability of AQW051 in Parkinson’s patients with L-dopa induced dyskinesias

Trenkwalder, Claudia and Berg, Daniela and Eggert, Karla and Oehlwein, Christian and Ceballos-Baumann, Andres and Feigin, Andrew and Coorvol, Jean Christophe and Rascol, Olivier and Stocchi, Fabrizio and Linazasoro, Gurutz and Di Paolo, Thérèse and Maruff, Paul and Feuerbach, Dominik and Sovago, Judit and Weiss, Markus and Rozenberg, Izabela and Johns, Donald and Gomez-Mancilla, Baltazar (2016) A multi-centre, randomized, double-blind, placebo-controlled, parallel-group, multiple oral dose study to assess the efficacy, safety and tolerability of AQW051 in Parkinson’s patients with L-dopa induced dyskinesias. Movement Disorders.

Abstract

In this study, administrationof AQW051 did not show any efect on dyskinesias or artiparkinsonian effect. However, The results of cognition assessments for the PD population indicated that the study drug AQW051 wasnot associated with statistically significant benefits to any cognitive domain or individual cognitive function. However when the magnitude of change under drug was compared to that under placebo,moderate to large effects were observed for the Memory Composite scores and the tasks comprisingthe Memory Composite score (ONB and ISLT), which were also found significant in the Safetypopulation for 50 mg versus placebo for ISLT and the Memory Composite score. Psychiatric and sleep problems are observed in 30-40% of PD patients. Some of the study patients showed mild to moderate depression at baseline, and mild sleep abnormalities. However, there was no overall effect of AQW051 in regards of SCOPA, BDI and PDSS results during the study.
Exposure to AQW051 in patients with Parkinson’s disease was as expected in an elderly population.
In regard to safety, administration of AQW051 showed good tolerability as in previous AQW051
studies, and the majority of AEs were mild to moderate in severity. Seven AEs were reported to be
severe in intensity of which 2 events were suspected to be related to study medication.

Item Type: Article
Keywords: AQW051 Parkinson's disease
Date Deposited: 26 Apr 2016 23:46
Last Modified: 26 Apr 2016 23:46
URI: https://oak.novartis.com/id/eprint/20791

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