A randomized trial of inhaled levodopa (CVT-301) for motor fluctuations in Parkinson's disease

LeWitt, P.A. et al. (2016) A randomized trial of inhaled levodopa (CVT-301) for motor fluctuations in Parkinson's disease. Movement Disorders, 31(9), pp. 1356-1365. (doi:10.1002/mds.26611) (PMID:27090868)

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Abstract

Although levodopa is the most effective oral PD therapy, many patients experience motor fluctuations, including sudden loss of dose effect and delayed benefit. CVT-301 is a levodopa inhalation powder with the potential for rapid onset of action. The objective of this study was to evaluate CVT-301 self-administered by PD patients to relieve OFF episodes.PD patients with ≥2 hours per day of OFF time despite oral levodopa ≥4 times per day were randomized to CVT-301 or placebo for 4 weeks, to be used up to 3 times per day for OFF episodes. After 2 weeks, the study-drug dose was escalated from 35 to 50 mg. The primary end point was mean change in UPDRS Part III score from a predose OFF state to the average of postdose scores obtained at 10, 20, 30, and 60 minutes, as assessed in-clinic at the end of week 4. Home diaries were recorded.Eighty-six patients used the study drug at an average frequency of 2.1 times per day for CVT-301 and for placebo. At 4 weeks, least-squares mean change in UPDRS Part III score favored CVT-301 by 7.0 points (P < 0.001). A treatment effect was evident at 10 minutes. At 4 weeks, least-squares mean OFF-time change from baseline favored CVT-301 by 0.9 hours per day (P = 0.045). The most frequently reported adverse events in the CVT-301 group were dizziness, cough, and nausea, each in 7% (3 of 43 patients).CVT-301 self-administered during OFF episodes provided rapid improvement of motor function, and daily OFF time was significantly reduced at the higher dose. CVT-301 was generally safe and well-tolerated.

Item Type:Articles
Additional Information:Funding agencies:: This study was supported by Civitas, now wholly owned by Acorda Therapeutics.
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Grosset, Dr Donald
Authors: LeWitt, P.A., Hauser, R.A., Grosset, D.G., Stocchi, F., Saint-Hilaire, M.-H., Ellenbogen, A., Leinonen, M., Hampson, N.B., DeFeo-Fraulini, T., Freed, M.I., and Kieburtz, K.D.
College/School:College of Medical Veterinary and Life Sciences > Institute of Neuroscience and Psychology
Journal Name:Movement Disorders
Publisher:Wiley
ISSN:0885-3185
ISSN (Online):1531-8257
Published Online:19 April 2016
Copyright Holders:Copyright © 2016 The Authors
First Published:First published in Movement Disorders 31:1356-1365
Publisher Policy:Reproduced under a creative commons licence
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