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Mov Disord. 2016 Sep;31(9):1356-65. doi: 10.1002/mds.26611. Epub 2016 Apr 19.

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

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Henry Ford Hospital and Wayne State University School of Medicine, West Bloomfield, Michigan, USA.
University of South Florida Byrd Parkinson Disease and Movement Disorders Center, Tampa, Florida, USA.
Institute of Neurological Sciences, Glasgow, United Kingdom.
IRCCS San Raffaele, Rome, Italy.
Boston University School of Medicine, Boston, Massachusetts, USA.
Quest Research Institute and Michigan Institute for Neurological Disorders, Farmington Hills, Michigan, USA.
4Pharma AB, Stockholm, Sweden.
Virginia Mason Medical Center, Seattle, Washington, USA.
Acorda Therapeutics, Chelsea, Massachusetts, USA.
Clintrex LLC, Rye, New York, USA.



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. © 2016 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.


CVT-301; Parkinson's disease; clinical trial; levodopa; motor fluctuations

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