THN 102 for excessive daytime sleepiness associated with Parkinson's disease: a phase 2a trial
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
Domaines
Neurosciences [q-bio.NC]
Fichier principal
Corvol et al. - THN 102 for Excessive Daytime Sleepiness Associate.pdf (1.2 Mo)
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