-
Je něco špatně v tomto záznamu ?
Long-term, continuous, subcutaneous levodopa/carbidopa infusion with ND0612 in Parkinson's disease: 3-year outcomes from the open-label BeyoND study
AL. Ellenbogen, W. Poewe, AJ. Espay, T. Simuni, T. Gurevich, T. Yardeni, N. Lopes, N. Sasson, R. Case, F. Stocchi, BeyoND study group
Jazyk angličtina Země Anglie, Velká Británie
Typ dokumentu časopisecké články, multicentrická studie
- MeSH
- antiparkinsonika * aplikace a dávkování škodlivé účinky MeSH
- fixní kombinace léků * MeSH
- karbidopa * aplikace a dávkování MeSH
- levodopa * aplikace a dávkování škodlivé účinky MeSH
- lidé středního věku MeSH
- lidé MeSH
- Parkinsonova nemoc * farmakoterapie MeSH
- senioři MeSH
- subkutánní infuze * MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
INTRODUCTION: ND0612 is being investigated as a continuous, subcutaneous levodopa/carbidopa infusion, in combination with oral levodopa/carbidopa, for motor fluctuations in Parkinson's disease (PD). One-year data from the ongoing BeyoND study (NCT02726386) showed that the ND0612 regimen was safe and well tolerated and provided a sustained ≥2-h improvement in daily Good ON-time through 12 months of treatment. METHODS: We describe 3-year safety and efficacy outcomes for participants who completed 12 months of ND0612 treatment in the core study period and entered the extension phase. RESULTS: Of the 214 enrolled participants, 120 completed the core 1-year period, and 114 participants continued into the extension phase. Of these, 95/114 (83.3 %) completed 2 years and 77/114 (67.5 %) completed 3 years of study treatment. Key reasons for discontinuation were treatment-emergent adverse events (TEAEs) (n = 5 and n = 11 after 2 and 3 years, respectively) and withdrawal of consent (n = 9 and n = 5, respectively). TEAEs were reported by 105/114 (92.1 %) participants in Year 1, 77/114 (67.5 %) in Year 2, and 73/95 (76.8 %) in Year 3. While most participants experienced infusion site reactions, these led to discontinuation in only five participants during this extension. At Month 36, the mean reduction in OFF-time from baseline was 2.81 h and the increase in Good ON-time was 2.79 h. CONCLUSIONS: Three-year results from this open-label study support the long-term safety, tolerability, and efficacy of ND0612. For participants who entered the extension phase, the high rate of retention supports a favorable benefit-risk ratio of the ND0612 regimen for patients with PD experiencing motor fluctuations.
Department of Neurology Medical University Innsbruck Innsbruck Austria
Department of Neurology Northwestern University Feinberg School of Medicine Chicago IL USA
Michigan Institute for Neurological Disorders Farmington Hills MI USA
Citace poskytuje Crossref.org
- 000
- 00000naa a2200000 a 4500
- 001
- bmc25009659
- 003
- CZ-PrNML
- 005
- 20250429134906.0
- 007
- ta
- 008
- 250415e20250116enk f 000 0|eng||
- 009
- AR
- 024 7_
- $a 10.1016/j.parkreldis.2025.107293 $2 doi
- 035 __
- $a (PubMed)39884033
- 040 __
- $a ABA008 $b cze $d ABA008 $e AACR2
- 041 0_
- $a eng
- 044 __
- $a enk
- 100 1_
- $a Ellenbogen, Aaron L $u Michigan Institute for Neurological Disorders, Farmington Hills, MI, USA. Electronic address: aaron@questri.com
- 245 10
- $a Long-term, continuous, subcutaneous levodopa/carbidopa infusion with ND0612 in Parkinson's disease: 3-year outcomes from the open-label BeyoND study / $c AL. Ellenbogen, W. Poewe, AJ. Espay, T. Simuni, T. Gurevich, T. Yardeni, N. Lopes, N. Sasson, R. Case, F. Stocchi, BeyoND study group
- 520 9_
- $a INTRODUCTION: ND0612 is being investigated as a continuous, subcutaneous levodopa/carbidopa infusion, in combination with oral levodopa/carbidopa, for motor fluctuations in Parkinson's disease (PD). One-year data from the ongoing BeyoND study (NCT02726386) showed that the ND0612 regimen was safe and well tolerated and provided a sustained ≥2-h improvement in daily Good ON-time through 12 months of treatment. METHODS: We describe 3-year safety and efficacy outcomes for participants who completed 12 months of ND0612 treatment in the core study period and entered the extension phase. RESULTS: Of the 214 enrolled participants, 120 completed the core 1-year period, and 114 participants continued into the extension phase. Of these, 95/114 (83.3 %) completed 2 years and 77/114 (67.5 %) completed 3 years of study treatment. Key reasons for discontinuation were treatment-emergent adverse events (TEAEs) (n = 5 and n = 11 after 2 and 3 years, respectively) and withdrawal of consent (n = 9 and n = 5, respectively). TEAEs were reported by 105/114 (92.1 %) participants in Year 1, 77/114 (67.5 %) in Year 2, and 73/95 (76.8 %) in Year 3. While most participants experienced infusion site reactions, these led to discontinuation in only five participants during this extension. At Month 36, the mean reduction in OFF-time from baseline was 2.81 h and the increase in Good ON-time was 2.79 h. CONCLUSIONS: Three-year results from this open-label study support the long-term safety, tolerability, and efficacy of ND0612. For participants who entered the extension phase, the high rate of retention supports a favorable benefit-risk ratio of the ND0612 regimen for patients with PD experiencing motor fluctuations.
- 650 _2
- $a lidé $7 D006801
- 650 12
- $a Parkinsonova nemoc $x farmakoterapie $7 D010300
- 650 12
- $a levodopa $x aplikace a dávkování $x škodlivé účinky $7 D007980
- 650 12
- $a karbidopa $x aplikace a dávkování $7 D002230
- 650 _2
- $a mužské pohlaví $7 D008297
- 650 _2
- $a ženské pohlaví $7 D005260
- 650 _2
- $a senioři $7 D000368
- 650 12
- $a fixní kombinace léků $7 D004338
- 650 _2
- $a lidé středního věku $7 D008875
- 650 12
- $a antiparkinsonika $x aplikace a dávkování $x škodlivé účinky $7 D000978
- 650 12
- $a subkutánní infuze $7 D055104
- 650 _2
- $a výsledek terapie $7 D016896
- 655 _2
- $a časopisecké články $7 D016428
- 655 _2
- $a multicentrická studie $7 D016448
- 700 1_
- $a Poewe, Werner $u Department of Neurology, Medical University Innsbruck, Innsbruck, Austria
- 700 1_
- $a Espay, Alberto J $u James J. and Joan A. Gardner Family Center for Parkinson's Disease and Movement Disorders, University of Cincinnati, Cincinnati, OH, USA
- 700 1_
- $a Simuni, Tanya $u Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA
- 700 1_
- $a Gurevich, Tanya $u Movement Disorders Unit, Neurological Institute, Tel Aviv Medical Centre, Faculty of Medicine, Sagol School of Neurosciences, Tel Aviv University, Tel Aviv, Israel
- 700 1_
- $a Yardeni, Tami $u NeuroDerm Ltd., Rehovot, Israel
- 700 1_
- $a Lopes, Nelson $u NeuroDerm Ltd., Rehovot, Israel
- 700 1_
- $a Sasson, Nissim $u NeuroDerm Ltd., Rehovot, Israel
- 700 1_
- $a Case, Ryan $u Mitsubishi Tanabe Pharma America, Inc., Jersey City, NJ, USA
- 700 1_
- $a Stocchi, Fabrizio $u University San Raffaele Roma and Institute for Research and Medical Care IRCCS San Raffaele, Roma, Italy
- 710 2_
- $a BeyoND study group
- 773 0_
- $w MED00006198 $t Parkinsonism & related disorders $x 1873-5126 $g Roč. 132 (20250116), s. 107293
- 856 41
- $u https://pubmed.ncbi.nlm.nih.gov/39884033 $y Pubmed
- 910 __
- $a ABA008 $b sig $c sign $y - $z 0
- 990 __
- $a 20250415 $b ABA008
- 991 __
- $a 20250429134902 $b ABA008
- 999 __
- $a ok $b bmc $g 2311183 $s 1246740
- BAS __
- $a 3
- BAS __
- $a PreBMC-MEDLINE
- BMC __
- $a 2025 $b 132 $c - $d 107293 $e 20250116 $i 1873-5126 $m Parkinsonism & related disorders $n Parkinsonism Relat Disord $x MED00006198
- LZP __
- $a Pubmed-20250415
