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• W2894489394 abstract "Objective: To characterize the pulmonary safety of CVT-301 84 mg vs standard-of-care over 12 months. Background: CVT-301 is an investigational therapy that delivers levodopa to the lungs. It is intended to treat OFF period symptoms in patients with Parkinson’s disease (PD) on an oral levodopa/dopa-decarboxylase inhibitor regimen. Design/Methods: A prospective, 12-month, open-label, randomized, controlled study of PD subjects experiencing motor fluctuations. Eligible subjects were randomized 2:1 to CVT-301 84 mg or to an observational cohort receiving oral standard-of-care. Major inclusion criteria: ability to perform spirometry in the ON/OFF states, screening forced expiratory volume in 1 second (FEV 1 ) ≥50%, and FEV 1 /forced vital capacity (FVC) ratio >60% in the ON state. Pulmonary safety was assessed using spirometry (FEV 1 , FVC, FEV 1 /FVC) and diffusion capacity of the lungs for carbon monoxide (DLco) assessments at screening, randomization (baseline), and at approximately 1, 3, 6, 9, and 12 months. Results: 408 subjects were randomized: 278 to CVT-301 and 130 to the observational cohort. In the CVT-301 group, 204 completed the study. Mean (SD) baseline characteristics for the CVT-301 group included: age 63.6 (8.5) years, PD duration 9.0 (4.8) years, daily OFF time 5.6 (2.0) hours/day, and number of OFF periods 3.6 (1.1)/day. Overall, the average number of CVT-301 doses was 2.3 (0.9)/day. The mean change (SD) from baseline in FEV 1 at week 52 was −0.117 L (0.214) for the observational cohort and −0.105 L (0.209) for the CVT-301 group. Similarly, there were no notable differences between CVT-301 and the observational cohort in the other spirometry parameters. Conclusions: Exposure to CVT-301 84 mg for up to 12 months did not alter the natural progression of pulmonary function, as shown by the spirometry and DLco assessments in a comparable observational cohort treated with oral PD medications. Study Supported by: Acorda Therapeutics, Inc. Disclosure: Dr. Grosset has nothing to disclose. Dr. Dhall has nothing to disclose. Dr. Gurevich has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Abbvie Israel, Neuroderm Ltd. Dr. Gurevich has received research support from Phonetica Ltd. Dr. Kassubek has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Jan Kassubek has been an investigator in clinical trials sponsored by Acorda. Dr. Poewe has nothing to disclose. Dr. Rascol has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Advisory Boards / Consultant: AbbVie, Adamas, Acorda, Addex, AlzProtect, Apopharma, Astrazeneca, Bial, Biogen, Britannia, Clevexel, Cynapsus, INC Reasearch, Lundbeck, Merck, MundiPharma, Neuroderm, Novartis, Oxford Biomedica, Parexel, Pfizer, Prexton Ther. Dr. Rascol has received research support from Grants Agence Nationale de la Recherche (ANR), CHU de Toulouse, France-Parkinson, INSERM-DHOS Recherche Clinique Translationnelle, MJFox Foundation, Programme Hospitalier de Recherche Clinique, European Commission (FP7, H2020). Dr. Rudzinska-Bar has nothing to disclose. Dr. Cormier has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee and stockholder of Acorda Therapeutics, Inc. Dr. Sedkov has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee and stockholder of Acorda Therapeutics, Inc. Dr. Oh has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee and stockholder of Acorda Therapeutics, Inc." @default.
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• W2894489394 date "2018-04-10" @default.
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• W2894489394 title "Long-Term Pulmonary Safety of Inhaled Levodopa in Parkinson’s Disease Subjects With Motor Fluctuations: a Phase 3 Open-Label Randomized Study (S26.006)" @default.
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