-
Something wrong with this record ?
THN 102 for Excessive Daytime Sleepiness Associated with Parkinson's Disease: A Phase 2a Trial
JC. Corvol, JP. Azulay, B. Bosse, Y. Dauvilliers, L. Defebvre, F. Klostermann, N. Kovacs, D. Maltête, WG. Ondo, R. Pahwa, W. Rein, S. Thobois, M. Valis, A. Videnovic, O. Rascol, THN102-202 Study Investigators
Language English Country United States
Document type Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
PubMed
34709684
DOI
10.1002/mds.28840
Knihovny.cz E-resources
- MeSH
- Double-Blind Method MeSH
- Drug Combinations MeSH
- Flecainide * adverse effects MeSH
- Humans MeSH
- Modafinil * adverse effects MeSH
- Parkinson Disease * drug therapy MeSH
- Disorders of Excessive Somnolence * etiology MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase II MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
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.
Department of Neurology Charité Universitätsmedizin Berlin Campus Benjamin Franklin Berlin Germany
Department of Neurology Massachusetts General Hospital Boston Massachusetts USA
Department of Neurology Medical School University of Pecs Pecs Hungary
Movement Disorders Division University of Kansas Medical Center Kansas City Kansas USA
Movement Disorders Methodist Neurological Institute Weill Cornel Medical School Houston Texas USA
References provided by Crossref.org
- 000
- 00000naa a2200000 a 4500
- 001
- bmc22011198
- 003
- CZ-PrNML
- 005
- 20220506130120.0
- 007
- ta
- 008
- 220425s2022 xxu f 000 0|eng||
- 009
- AR
- 024 7_
- $a 10.1002/mds.28840 $2 doi
- 035 __
- $a (PubMed)34709684
- 040 __
- $a ABA008 $b cze $d ABA008 $e AACR2
- 041 0_
- $a eng
- 044 __
- $a xxu
- 100 1_
- $a Corvol, Jean-Christophe $u Department of Neurology, Centre d'Investigation Clinique Neurosciences, NS-PARK/FCRIN Network, Sorbonne Université, Assistance Publique Hôpitaux de Paris, Paris Brain Institute-ICM, INSERM, CNRS, Hôpital Pitié-Salpêtrière, Paris, France $1 https://orcid.org/0000000173250199
- 245 10
- $a THN 102 for Excessive Daytime Sleepiness Associated with Parkinson's Disease: A Phase 2a Trial / $c JC. Corvol, JP. Azulay, B. Bosse, Y. Dauvilliers, L. Defebvre, F. Klostermann, N. Kovacs, D. Maltête, WG. Ondo, R. Pahwa, W. Rein, S. Thobois, M. Valis, A. Videnovic, O. Rascol, THN102-202 Study Investigators
- 520 9_
- $a 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.
- 650 12
- $a poruchy nadměrné spavosti $x etiologie $7 D006970
- 650 _2
- $a dvojitá slepá metoda $7 D004311
- 650 _2
- $a fixní kombinace léků $7 D004338
- 650 12
- $a flekainid $x škodlivé účinky $7 D005424
- 650 _2
- $a lidé $7 D006801
- 650 12
- $a modafinil $x škodlivé účinky $7 D000077408
- 650 12
- $a Parkinsonova nemoc $x farmakoterapie $7 D010300
- 655 _2
- $a klinické zkoušky, fáze II $7 D017427
- 655 _2
- $a časopisecké články $7 D016428
- 655 _2
- $a randomizované kontrolované studie $7 D016449
- 655 _2
- $a práce podpořená grantem $7 D013485
- 700 1_
- $a Azulay, Jean-Philippe $u Department of Neurology and Movement Disorders, La Timone Hospital, Assistance Publique-Hôpitaux de Marseille, NS-PARK/FCRIN Network, Marseille, France
- 700 1_
- $a Bosse, Björn $u Scope International, Mannheim, Germany
- 700 1_
- $a Dauvilliers, Yves $u Sleep-Wake Disorders Center, Department of Neurology, Gui-de-Chauliac Hospital, CHU Montpellier, University of Montpellier, Montpellier, France
- 700 1_
- $a Defebvre, Luc $u Department of Neurology and Movement Disorders, Lille University Medical Center, NS-PARK/FCRIN Network, Lille, France
- 700 1_
- $a Klostermann, Fabian $u Department of Neurology, Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin, Berlin, Germany
- 700 1_
- $a Kovacs, Norbert $u Department of Neurology, Medical School University of Pecs, Pecs, Hungary
- 700 1_
- $a Maltête, David $u Department of Neurology, Rouen University Hospital and University of Rouen, NS-PARK/FCRIN Network, Rouen, France
- 700 1_
- $a Ondo, William G $u Movement Disorders-Methodist Neurological Institute, Weill Cornel Medical School, Houston, Texas, USA
- 700 1_
- $a Pahwa, Rajesh $u Movement Disorders Division, University of Kansas Medical Center, Kansas City, Kansas, USA
- 700 1_
- $a Rein, Werner $u Theranexus SA, Lyon, France
- 700 1_
- $a Thobois, Stéphane $u Department of Neurology C, Pierre-Wertheimer Neurological Hospital, Hospices Civils de Lyon, NS-PARK/FCRIN Network, Univ Lyon, CNRS, Institut des Sciences Cognitives Marc Jeannerod, Bron, France
- 700 1_
- $a Valis, Martin $u Department of Neurology, Charles University, Faculty of Medicine and University Hospital, Hradec Kralove, Czechia
- 700 1_
- $a Videnovic, Aleksandar $u Department of Neurology, Massachusetts General Hospital, Boston, Massachusetts, USA $1 https://orcid.org/0000000292371516
- 700 1_
- $a Rascol, Olivier $u Departments of Neurology and Clinical Pharmacology, Centre of Clinique Investigations, NS-Park/FCRIN Network, Centre of Excellence for Neurodegenerative Disorders (COEN) of Toulouse, CHU de Toulouse, Toulouse 3 University, NS-PARK/FCRIN Network, Toulouse, France
- 710 2_
- $a THN102-202 Study Investigators
- 773 0_
- $w MED00003420 $t Movement disorders : official journal of the Movement Disorder Society $x 1531-8257 $g Roč. 37, č. 2 (2022), s. 410-415
- 856 41
- $u https://pubmed.ncbi.nlm.nih.gov/34709684 $y Pubmed
- 910 __
- $a ABA008 $b sig $c sign $y p $z 0
- 990 __
- $a 20220425 $b ABA008
- 991 __
- $a 20220506130112 $b ABA008
- 999 __
- $a ok $b bmc $g 1789014 $s 1162396
- BAS __
- $a 3
- BAS __
- $a PreBMC
- BMC __
- $a 2022 $b 37 $c 2 $d 410-415 $e 20211028 $i 1531-8257 $m Movement disorders $n Mov Disord $x MED00003420
- LZP __
- $a Pubmed-20220425
