TY - JOUR
T1 - THN 102 for Excessive Daytime Sleepiness Associated with Parkinson's Disease
T2 - A Phase 2a Trial
AU - for the THN102-202 Study Investigators
AU - Corvol, Jean Christophe
AU - Azulay, Jean Philippe
AU - Bosse, Björn
AU - Dauvilliers, Yves
AU - Defebvre, Luc
AU - Klostermann, Fabian
AU - Kovacs, Norbert
AU - Maltête, David
AU - Ondo, William G.
AU - Pahwa, Rajesh
AU - Rein, Werner
AU - Thobois, Stéphane
AU - Valis, Martin
AU - Videnovic, Aleksandar
AU - Rascol, Olivier
AU - Corvol, Jean Christophe
AU - Azulay, Jean Philippe
AU - Baláž, Marek
AU - Bodenschatz, Ralf
AU - Bokor, Magdolna
AU - Brožová, Hana
AU - Dauvilliers, Yves
AU - Defebvre, Luc
AU - Fiala, Ondraj
AU - Folyovich, Andràs
AU - Herbst, Heinz Peter
AU - Klostermann, Fabian
AU - Lajtos, Julianna
AU - Lingor, Paul
AU - Maltête, David
AU - Oehlwein, Christian
AU - Pahwa, Rajesh
AU - Peregrin, Jan
AU - Rascol, Olivier
AU - Rau, Daniela
AU - Safavi, Ali
AU - Springub, Joachim
AU - Svátová, Jindra
AU - Thobois, Stéphane
AU - Lyon, Univ
AU - Valis, Martin
AU - Vécsei, Làszlo
AU - Videnovic, Aleksandar
AU - Waln, Olga
AU - Zárubová, Katarina
N1 - Funding Information:
Research reported in this publication was funded by Theranexus. This research was partially supported by grant projects of the Ministry of Health of the Czech Republic (FN HK 00179906) and of the Charles University in Prague, Czech Republic (PROGRES Q40). We are thankful to the patients who participated in the study.
Funding Information:
This study was funded by Theranexus. Funding agency:
Publisher Copyright:
© 2021 International Parkinson and Movement Disorder Society
PY - 2022/2/1
Y1 - 2022/2/1
N2 - 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.
AB - 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.
KW - Parkinson's disease; sleepiness; clinical trial; modafinil; flecainide
KW - Disorders of Excessive Somnolence/etiology
KW - Parkinson Disease/drug therapy
KW - Double-Blind Method
KW - Humans
KW - Modafinil/adverse effects
KW - Drug Combinations
KW - Flecainide/adverse effects
UR - http://www.scopus.com/inward/record.url?scp=85118345022&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85118345022&partnerID=8YFLogxK
U2 - 10.1002/mds.28840
DO - 10.1002/mds.28840
M3 - Article
C2 - 34709684
AN - SCOPUS:85118345022
SN - 0885-3185
VL - 37
SP - 410
EP - 415
JO - Movement Disorders
JF - Movement Disorders
IS - 2
ER -