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THN 102 for Excessive Daytime Sleepiness Associated with Parkinson's Disease: A Phase 2a Trial
Author(s) -
Corvol JeanChristophe,
Azulay JeanPhilippe,
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
Publication year - 2022
Publication title -
movement disorders
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.352
H-Index - 198
eISSN - 1531-8257
pISSN - 0885-3185
DOI - 10.1002/mds.28840
Subject(s) - modafinil , epworth sleepiness scale , placebo , excessive daytime sleepiness , medicine , parkinson's disease , clinical endpoint , crossover study , confidence interval , anesthesia , randomized controlled trial , psychology , pharmacology , sleep disorder , polysomnography , disease , insomnia , apnea , alternative medicine , pathology
Background 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. Objective The aim of this study is to evaluate the safety and efficacy of THN102 in PD patients with EDS. Methods 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. Results 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. Conclusions 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