Back to Search
Start Over
A randomized trial of inhaled levodopa (CVT-301) for motor fluctuations in Parkinson's disease
- Source :
- Movement Disorders. 31:1356-1365
- Publication Year :
- 2016
- Publisher :
- Wiley, 2016.
-
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
- Subjects :
- 0301 basic medicine
medicine.medical_specialty
Levodopa
Movement disorders
Parkinson's disease
Nausea
Placebo
law.invention
03 medical and health sciences
0302 clinical medicine
Randomized controlled trial
law
medicine
Clinical endpoint
Adverse effect
business.industry
medicine.disease
Surgery
030104 developmental biology
Neurology
Anesthesia
Neurology (clinical)
medicine.symptom
business
030217 neurology & neurosurgery
medicine.drug
Subjects
Details
- ISSN :
- 08853185
- Volume :
- 31
- Database :
- OpenAIRE
- Journal :
- Movement Disorders
- Accession number :
- edsair.doi...........7b7a3e7e3e0fd0751f837dd8a9e16c46