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

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11150%2F22%3A10438267" target="_blank" >RIV/00216208:11150/22:10438267 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00179906:_____/22:10438267

Výsledek na webu

<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=EpC_ffMCuf" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=EpC_ffMCuf</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1002/mds.28840" target="_blank" >10.1002/mds.28840</a>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

Background Excessive daytime sleepiness (EDS) is a frequent and disabling symptom of Parkinson&apos;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. (c) 2021 International Parkinson and Movement Disorder Society

Název v anglickém jazyce

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

Popis výsledku anglicky

Background Excessive daytime sleepiness (EDS) is a frequent and disabling symptom of Parkinson&apos;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. (c) 2021 International Parkinson and Movement Disorder Society

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30103 - Neurosciences (including psychophysiology)

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2022

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Movement Disorders

ISSN

0885-3185

e-ISSN

1531-8257

Svazek periodika

37

Číslo periodika v rámci svazku

2

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

6

Strana od-do

410-415

Kód UT WoS článku

000711904900001

EID výsledku v databázi Scopus

2-s2.0-85118345022