THN 102 for Excessive Daytime Sleepiness Associated with Parkinson's Disease: A Phase 2a Trial

for the THN102-202 Study Investigators

doi:10.1002/mds.28840

THN 102 for Excessive Daytime Sleepiness Associated with Parkinson's Disease: A Phase 2a Trial

for the THN102-202 Study Investigators

Research output: Contribution to journal › Article › peer-review

5 Scopus citations

Abstract

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.

Original language	English (US)
Pages (from-to)	410-415
Number of pages	6
Journal	Movement Disorders
Volume	37
Issue number	2
DOIs	https://doi.org/10.1002/mds.28840
State	Published - Feb 1 2022

Keywords

Parkinson's disease; sleepiness; clinical trial; modafinil; flecainide
Disorders of Excessive Somnolence/etiology
Parkinson Disease/drug therapy
Double-Blind Method
Humans
Modafinil/adverse effects
Drug Combinations
Flecainide/adverse effects

ASJC Scopus subject areas

Clinical Neurology
Neurology

Access to Document

10.1002/mds.28840

Cite this

@article{15e3187983d04ec49eb22709d4f409b3,

title = "THN 102 for Excessive Daytime Sleepiness Associated with Parkinson's Disease: A Phase 2a Trial",

abstract = "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. {\textcopyright} 2021 International Parkinson and Movement Disorder Society.",

keywords = "Parkinson's disease; sleepiness; clinical trial; modafinil; flecainide, Disorders of Excessive Somnolence/etiology, Parkinson Disease/drug therapy, Double-Blind Method, Humans, Modafinil/adverse effects, Drug Combinations, Flecainide/adverse effects",

author = "{for the THN102-202 Study Investigators} and Corvol, {Jean Christophe} and Azulay, {Jean Philippe} and Bj{\"o}rn Bosse and Yves Dauvilliers and Luc Defebvre and Fabian Klostermann and Norbert Kovacs and David Malt{\^e}te and Ondo, {William G.} and Rajesh Pahwa and Werner Rein and St{\'e}phane Thobois and Martin Valis and Aleksandar Videnovic and Olivier Rascol and Corvol, {Jean Christophe} and Azulay, {Jean Philippe} and Marek Bal{\'a}{\v z} and Ralf Bodenschatz and Magdolna Bokor and Hana Bro{\v z}ov{\'a} and Yves Dauvilliers and Luc Defebvre and Ondraj Fiala and Andr{\`a}s Folyovich and Herbst, {Heinz Peter} and Fabian Klostermann and Julianna Lajtos and Paul Lingor and David Malt{\^e}te and Christian Oehlwein and Rajesh Pahwa and Jan Peregrin and Olivier Rascol and Daniela Rau and Ali Safavi and Joachim Springub and Jindra Sv{\'a}tov{\'a} and St{\'e}phane Thobois and Univ Lyon and Martin Valis and L{\`a}szlo V{\'e}csei and Aleksandar Videnovic and Olga Waln and Katarina Z{\'a}rubov{\'a}",

note = "Publisher Copyright: {\textcopyright} 2021 International Parkinson and Movement Disorder Society",

year = "2022",

month = feb,

day = "1",

doi = "10.1002/mds.28840",

language = "English (US)",

volume = "37",

pages = "410--415",

journal = "Movement Disorders",

issn = "0885-3185",

publisher = "Wiley",

number = "2",

}

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

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 -

THN 102 for Excessive Daytime Sleepiness Associated with Parkinson's Disease: A Phase 2a Trial

Abstract

Keywords

ASJC Scopus subject areas

Access to Document

Other files and links

Fingerprint

Cite this