Long-term, continuous, subcutaneous levodopa/carbidopa infusion with ND0612 in Parkinson's disease: 3-year outcomes from the open-label BeyoND study
Language English Country England, Great Britain Media print-electronic
Document type Clinical Trial, Phase II, Journal Article, Multicenter Study
PubMed
39884033
DOI
10.1016/j.parkreldis.2025.107293
PII: S1353-8020(25)00034-3
Knihovny.cz E-resources
- Keywords
- Infusion, Levodopa, Motor complications, ND0612, Parkinson's disease,
- MeSH
- Antiparkinson Agents * administration & dosage adverse effects pharmacology MeSH
- Drug Combinations MeSH
- Outcome Assessment, Health Care * MeSH
- Carbidopa * administration & dosage adverse effects pharmacology MeSH
- Levodopa * administration & dosage adverse effects pharmacology MeSH
- Middle Aged MeSH
- Humans MeSH
- Parkinson Disease * drug therapy MeSH
- Aged MeSH
- Infusions, Subcutaneous MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase II MeSH
- Multicenter Study MeSH
- Names of Substances
- Antiparkinson Agents * MeSH
- carbidopa, levodopa drug combination MeSH Browser
- Drug Combinations MeSH
- Carbidopa * MeSH
- Levodopa * 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
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