THN 102 for Excessive Daytime Sleepiness Associated with Parkinson's Disease

Corvol, Jean-Christophe and Azulay, Jean-Philippe and Bosse, Björn and Dauvilliers, Yves and Defebvre, Luc and Kovács, Norbert and Folyovich, András and Vécsei, László (2021) THN 102 for Excessive Daytime Sleepiness Associated with Parkinson's Disease. MOVEMENT DISORDERS. ISSN 0885-3185

Text 2021_MD_THN_CorvoletalMovDisord2021.pdf Restricted to Registered users only Download (260kB) | Request a copy

Abstract

Excessive 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.The aim of this study is to evaluate the safety and efficacy of THN102 in PD patients with EDS.The 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.Both 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.THN102 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.

Actions (login required)

Edit Item