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Pracoviště
Department of Neurology C Pierre Wert... 1 Department of Neurology Centre d'Inve... 1 Department of Neurology Charité Unive... 1 Department of Neurology Charles Unive... 1 Department of Neurology Massachusetts... 1 Department of Neurology Medical Schoo... 1 Department of Neurology Rouen Univers... 1 Department of Neurology and Movement ... 1 Department of Neurology and Movement ... 1 Departments of Neurology and Clinical... 1 Movement Disorders Division Universit... 1 Movement Disorders Methodist Neurolog... 1 Scope International Mannheim Germany 1 Sleep Wake Disorders Center Departmen... 1 Theranexus SA Lyon France 1
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- Autor
- Organizace
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Pracoviště
Department of Neurology C Pierre Wert... 1 Department of Neurology Centre d'Inve... 1 Department of Neurology Charité Unive... 1 Department of Neurology Charles Unive... 1 Department of Neurology Massachusetts... 1 Department of Neurology Medical Schoo... 1 Department of Neurology Rouen Univers... 1 Department of Neurology and Movement ... 1 Department of Neurology and Movement ... 1 Departments of Neurology and Clinical... 1 Movement Disorders Division Universit... 1 Movement Disorders Methodist Neurolog... 1 Scope International Mannheim Germany 1 Sleep Wake Disorders Center Departmen... 1 Theranexus SA Lyon France 1
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NLK
Medline Complete (EBSCOhost)
od 2012-01-01 do Před 1 rokem
PubMed
34709684
DOI
10.1002/mds.28840
Knihovny.cz E-zdroje
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.
- MeSH
- dvojitá slepá metoda MeSH
- fixní kombinace léků MeSH
- flekainid * škodlivé účinky MeSH
- lidé MeSH
- modafinil * škodlivé účinky MeSH
- Parkinsonova nemoc * farmakoterapie MeSH
- poruchy nadměrné spavosti * etiologie MeSH
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- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze II MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
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