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

Peter A. LeWitt, Robert A. Hauser, Donald G. Grosset, Fabrizio Stocchi, Marie Helene Saint-Hilaire, Aaron Ellenbogen, Mika Leinonen, Neil B. Hampson, Tia DeFeo-Fraulini, Martin I. Freed, Karl D. Kieburtz

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)1356-1365
Number of pages10
JournalMovement Disorders
Volume31
Issue number9
DOIs
Publication statusPublished - Sep 1 2016

Keywords

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

ASJC Scopus subject areas

  • Medicine(all)
  • Neurology
  • Clinical Neurology

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