Document detail
ID
oai:HAL:hal-03416717v1
Topic
Parkinson's disease sleepiness clinical trial modafinil flecainide [SDV.NEU]Life Sciences [q-bio]/Neu...Author
Corvol, Jean‐christophe Azulay, Jean‐philippe Bosse, Björn Dauvilliers, Yves Defebvre, Luc Klostermann, Fabian Kovacs, Norbert Maltête, David Ondo, William, G Pahwa, Rajesh Rein, Werner Thobois, Stéphane Valis, Martin Videnovic, Aleksandar Rascol, OlivierLangue
enEditor
HAL CCSD;Wiley
Category
CNRS - Centre national de la recherche scientifique
Year
2021
listing date
12/15/2023
Keywords
modafinil eds trial disease pd efficacy flecainide parkinson thn102Abstract
International audience; BackgroundExcessive daytime sleepiness (EDS) is a frequent and disabling symptom of Parkinson's disease (PD) without approved treatment.
THN102 is a novel combination drug of modafinil and low-dose flecainide.ObjectiveThe aim of this study is to evaluate the safety and efficacy of THN102 in PD patients with EDS.MethodsThe method involved a randomized, double-blind, placebo-controlled, crossover trial testing two doses of THN102 (200 mg/d modafinil with 2 mg/d [200/2] or 18 mg/d flecainide [200/18]) versus placebo; 75 patients were exposed to treatment.
The primary endpoint was safety.
The primary efficacy outcome was the change in Epworth Sleepiness Scale (ESS) score.ResultsBoth doses of THN102 were well tolerated.
ESS significantly improved with THN102 200/2 (least square means vs. placebo [95% confidence interval, CI]: −1.4 [−2.49; −0.31], P = 0.012) but did not change significantly with the 200/18 dosage.ConclusionsTHN102 was well tolerated and showed a signal of efficacy at the 200/2 dose, supporting further development for the treatment of EDS in PD.
© 2021 International Parkinson and Movement Disorder Society
Corvol, Jean‐christophe,Azulay, Jean‐philippe,Bosse, Björn,Dauvilliers, Yves,Defebvre, Luc,Klostermann, Fabian,Kovacs, Norbert,Maltête, David,Ondo, William, G,Pahwa, Rajesh,Rein, Werner,Thobois, Stéphane,Valis, Martin,Videnovic, Aleksandar,Rascol, Olivier, 2021, THN 102 for excessive daytime sleepiness associated with Parkinson's disease: a phase 2a trial, HAL CCSD;Wiley
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