THN 102 for Excessive Daytime Sleepiness Associated with Parkinson's Disease: A Phase 2a Trial.
Parkinson's disease; sleepiness; clinical trial; modafinil; flecainide
Journal
Movement disorders : official journal of the Movement Disorder Society
ISSN: 1531-8257
Titre abrégé: Mov Disord
Pays: United States
ID NLM: 8610688
Informations de publication
Date de publication:
02 2022
02 2022
Historique:
revised:
30
09
2021
received:
10
04
2021
accepted:
02
10
2021
pubmed:
29
10
2021
medline:
18
3
2022
entrez:
28
10
2021
Statut:
ppublish
Résumé
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. The aim of this study is to evaluate the safety and efficacy of THN102 in PD patients with EDS. 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. 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. 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.
Sections du résumé
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.
Substances chimiques
Drug Combinations
0
Flecainide
K94FTS1806
Modafinil
R3UK8X3U3D
Types de publication
Clinical Trial, Phase II
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
410-415Investigateurs
Jean-Christophe Corvol
(JC)
Jean-Philippe Azulay
(JP)
Marek Baláž
(M)
Ralf Bodenschatz
(R)
Magdolna Bokor
(M)
Hana Brožová
(H)
Yves Dauvilliers
(Y)
Luc Defebvre
(L)
Ondraj Fiala
(O)
Andràs Folyovich
(A)
Heinz Peter Herbst
(HP)
Fabian Klostermann
(F)
Norbert Kovacs
(N)
Julianna Lajtos
(J)
Paul Lingor
(P)
David Maltête
(D)
Christian Oehlwein
(C)
Rajesh Pahwa
(R)
Jan Peregrin
(J)
Olivier Rascol
(O)
Daniela Rau
(D)
Ali Safavi
(A)
Joachim Springub
(J)
Jindra Svátová
(J)
Stéphane Thobois
(S)
Univ Lyon
(U)
Martin Valis
(M)
Làszlo Vécsei
(L)
Aleksandar Videnovic
(A)
Olga Waln
(O)
Katarina Zárubová
(K)
Informations de copyright
© 2021 International Parkinson and Movement Disorder Society.
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