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.
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| http://dx.doi.org/10.1002/mds.28840 | DOI Listing |
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Article Synopsis
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- Research using transgenic Drosophila models showed that flies overexpressing α-syn experienced excessive daytime sleepiness and difficulties in anticipating activities, alongside identified deficits in specific neurons linked to sleep and circadian rhythm.
- The study found that disrupting lipid metabolism through the inhibition of Sterol Regulatory Element-Binding Protein (SREBP) improved daytime sleep duration in α-syn overexpressing flies, suggesting potential therapeutic strategies for PD-related sleep disturbances.
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