THN 102 for Excessive Daytime Sleepiness Associated with Parkinson's Disease: A Phase 2a Trial
The result's identifiers
Result code in 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>
Alternative codes found
RIV/00179906:_____/22:10438267
Result on the web
<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>
Alternative languages
Result language
angličtina
Original language name
THN 102 for Excessive Daytime Sleepiness Associated with Parkinson's Disease: A Phase 2a Trial
Original language description
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. (c) 2021 International Parkinson and Movement Disorder Society
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30103 - Neurosciences (including psychophysiology)
Result continuities
Project
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Continuities
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Others
Publication year
2022
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Movement Disorders
ISSN
0885-3185
e-ISSN
1531-8257
Volume of the periodical
37
Issue of the periodical within the volume
2
Country of publishing house
US - UNITED STATES
Number of pages
6
Pages from-to
410-415
UT code for WoS article
000711904900001
EID of the result in the Scopus database
2-s2.0-85118345022