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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.

Author information

1
Henry Ford Hospital and Wayne State University School of Medicine, West Bloomfield, Michigan, USA. plewitt1@hfhs.org.
2
University of South Florida Byrd Parkinson Disease and Movement Disorders Center, Tampa, Florida, USA.
3
Institute of Neurological Sciences, Glasgow, United Kingdom.
4
IRCCS San Raffaele, Rome, Italy.
5
Boston University School of Medicine, Boston, Massachusetts, USA.
6
Quest Research Institute and Michigan Institute for Neurological Disorders, Farmington Hills, Michigan, USA.
7
4Pharma AB, Stockholm, Sweden.
8
Virginia Mason Medical Center, Seattle, Washington, USA.
9
Acorda Therapeutics, Chelsea, Massachusetts, USA.
10
Clintrex LLC, Rye, New York, USA.

Abstract

BACKGROUND:

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.

METHODS:

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.

RESULTS:

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).

CONCLUSIONS:

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.

KEYWORDS:

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

PMID:
27090868
DOI:
10.1002/mds.26611
[Indexed for MEDLINE]

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