Trial reportCNS drugs2015
Long-Term Treatment with Extended-Release Carbidopa-Levodopa (IPX066) in Early and Advanced Parkinson's Disease: A 9-Month Open-Label Extension Trial.
Trial report in CNS drugs, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
15 citing papers in PubMed, 35 citations in OpenAlex.
- Conversion to IPX066 from Standard Levodopa Formulations in Advanced Parkinson's Disease: Experience in Clinical Trials.Journal of Parkinson's disease · 2015Trial
- Model-based optimization of controlled release formulation of levodopa for Parkinson's disease.Scientific reports · 2023Article
- Transcriptome profiling of five brain regions in a 6-hydroxydopamine rat model of Parkinson's disease.CNS neuroscience & therapeutics · 2021Article
- Potency of Selected Berries, Grapes, and Citrus Fruit as Neuroprotective Agents.Evidence-based complementary and alternative medicine : eCAM · 2020Review
- Less Pulsatile Levodopa Therapy (6 Doses Daily) Is Associated with a Reduced Incidence of Dyskinesia.Journal of movement disorders · 2019Article
- Improved Bioavailability of Levodopa Using Floatable Spray-Coated Microcapsules for the Management of Parkinson's Disease.Neuromolecular medicine · 2018Article
- Levodopa in Parkinson's Disease: Current Status and Future Developments.Current neuropharmacology · 2018Review
- Extended-release oral capsule of carbidopa-levodopa in Parkinson disease.Therapeutic advances in neurological disorders · 2018Review
- Onset and duration of effect of extended-release carbidopa-levodopa in advanced Parkinson's disease.Neuropsychiatric disease and treatment · 2018Article
- Pharmacokinetics of RytaryClinical pharmacokinetics · 2017Review
- Continuous Transdermal Delivery of L-DOPA Based on a Self-Assembling Nanomicellar System.Pharmaceutical research · 2017Article
- Recent advances in treating Parkinson's disease.F1000Research · 2017Review
- Novel Levodopa Formulations for Parkinson's Disease.CNS drugs · 2016Review
- Novel Approaches to Optimization of Levodopa Therapy for Parkinson's Disease.Current neurology and neuroscience reports · 2016Review
- Carbidopa/Levodopa ER Capsules (Rytary(®), Numient™): A Review in Parkinson's Disease.CNS drugs · 2016Review
Corrections and comments
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Authors and funding
11 authors at 4 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectiveIPX066 is a multiparticulate extended-release formulation of carbidopa-levodopa, designed to produce prolonged therapeutic levodopa plasma concentrations. This 9-month open-label extension study assessed its long-term safety and clinical utility in early and advanced Parkinson's disease (PD).
methodsParticipants were enrolled from two phase III IPX066 studies and one open-label phase II study. Early PD patients were titrated to an appropriate dosing regimen while advanced patients started with regimens established in the antecedent studies. Adjustment was allowed throughout the extension. Clinical utility measures included the Unified Parkinson's Disease Rating Scale (UPDRS) and Patient Global Impression (PGI) ratings.
resultsAmong 268 early PD patients, 53.4 % reported adverse events (AEs) and 1.1 % (three patients) discontinued due to AEs; the most frequent AEs were nausea (5.6 %) and insomnia (5.6 %). Among 349 advanced patients, 60.2 % reported AEs and 3.7 % (13 patients) discontinued due to AEs; the most frequent AEs were dyskinesia (6.9 %) and fall (6.6 %). At month 9 (or early termination), 78.3 % of early patients were taking IPX066 three times daily (median: 720 mg/day) and 87.7 % of advanced patients were taking IPX066 three or four times daily (median: 1450 mg/day). Adjusting for 70 % bioavailability relative to immediate-release (IR) carbidopa-levodopa, the median dosages correspond to ~500 and ~1015 mg/day of IR levodopa in early and advanced PD, respectively. Based on the plasma profiles previously observed in PD patients, the IPX066 regimens in the extension can be estimated to provide a levodopa Cmax (maximum plasma drug concentration) similar to or lower than that provided by IR regimens during the antecedent trials. UPDRS and PGI findings showed sustained treatment effects throughout the extension.
conclusionDuring 9 months of extended use, IPX066 exhibited a safety/tolerability profile consistent with dopaminergic PD therapy.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.