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• W2805837906 abstract "Objective: Safety assessment of CVT-301 84 mg when administered with oral carbidopa/levodopa for early morning OFF symptoms. Background: CVT-301, an investigational therapy that delivers levodopa to the lungs, is in development for treatment of OFF period symptoms in patients with Parkinson’s disease (PD) on an oral levodopa/dopa-decarboxylase inhibitor regimen. Design/Methods: A randomized, double-blind, 2-way crossover study. Eligible subjects received a single dose of CVT-301 84 mg or placebo in 2 dosing periods. On the morning of dosing days, subjects delayed taking their standard early morning oral carbidopa/levodopa dose until they arrived at study site. A single dose of CVT-301 or placebo was administered in the OFF state immediately after their morning standard carbidopa/levodopa dose. Subjects resumed their standard regimen of oral carbidopa/levodopa and other PD medications in the interval between the dosing periods. Plasma carbidopa concentrations were assessed in a subset of subjects. Safety assessments included treatment-emergent adverse events (TEAEs), routine and orthostatic vital signs, and self-reported and examiner-reported dyskinesia. Results: Thirty-six subjects (mean age 62.9 years) were enrolled and completed the study. Overall, 9 (25.0%) subjects and 4 (11.1%) subjects reported TEAEs following CVT-301 and placebo administration, respectively. The most common TEAE was cough: 4 (11.1%) subjects in CVT-301 group vs 1 (2.8%) in placebo. A clear relationship between TEAEs and carbidopa trough concentrations was not observed. There were no apparent treatment-related trends in routine vital signs data. Orthostatic hypotension was similar following CVT-301 (7 subjects) and placebo (7 subjects) administration, and those events were asymptomatic. The incidence and severity of examiner-rated dyskinesia in the 3 hours postdose were similar following administration of CVT-301 and placebo. Conclusions: Single doses of CVT-301 84 mg when administered with oral carbidopa/levodopa for early morning OFF symptoms were well tolerated, with no notable safety concerns. Study Supported by: Acorda Therapeutics, Inc. Disclosure: Dr. Ellenbogen has nothing to disclose. Dr. Hauser has nothing to disclose. Dr. Isaacson has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Consultancy and/or promotional speaker fees: Acadia, Acorda, Adamas, Allergan, Amarantus, Biotie, Britannia, Cynapsus, GE Pharma, Impax, Ipsen, Kyowa, Lundbeck, Teva, UCB, and US WorldMeds. Research funding: AbbVie, Acadia, Acorda, Adamas, Addex, Allergan. Dr. Safirstein has nothing to disclose. Dr. Truong has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Research support from Acadia, Adamas, Axovant, Bristol-Myers Squibb, Civitas, Cynapsus, Impax, Intec, Kyowa, Lundbeck, Neuroderm, Parkinson Study Group, Revance, Sunovion, and UCB. Speaker bureau of US World Med. Royalties from Cambridge, Wiley Blackwell. Dr. Zhao 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. Komjathy 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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• W2805837906 date "2018-04-10" @default.
• W2805837906 modified "2023-09-25" @default.
• W2805837906 title "Inhaled Levodopa Administered With Oral Carbidopa/Levodopa for Early Morning OFF Symptoms in Patients With Parkinson’s Disease: Safety Assessment (S26.005)" @default.
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