Efficacy and Safety Study of Inhaled CVT 301 in Parkinson's Disease Patients for Treatment of OFF Episodes

Completed · Phase 2 · Has a placebo group

Conditions studied: Idiopathic Parkinson's Disease

In brief

This randomized, multicenter, placebo-controlled, double-blind study will evaluate the efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing motor response fluctuations (OFF phenomena) as an outpatient (i.e., at home) and in the clinic.

Key facts

Study ID

NCT01777555

Run by

Acorda Therapeutics

People needed

89

Starts

2013-04-01

Expected to finish

2014-01-01

Last updated by the study team

2018-08-08

Who can join

Age: 30 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Idiopathic Parkinson's Disease (PD) diagnosed between the ages of 30 and 80 years;
• Hoehn and Yahr Stage 1-3 in an "on" state;
• Require levodopa-containing medication regimen at least 4 times during the waking day;
• Experience motor fluctuations with a minimum of 2 hours of average daily "off" time per waking day (excluding early morning "off" time) and demonstrate levodopa responsiveness;
• Are on stable PD medication regimen.

You may not qualify if…

• Pregnant or lactating females;
• Previous surgery for PD or plan to have stereotactic surgery during the study period;
• History of psychotic symptoms requiring treatment, or suicide ideation or attempt within last year;
• Adequate lung function as measured by spirometry;
• Any significant condition, severe concurrent disease, abnormality or finding that would make patients unsuitable or may compromise patient safety.

Where it is running

• Civitas Investigational Site 1013 — Little Rock, Arkansas, United States
• Civitas Investigational Site 1004 — Boca Raton, Florida, United States
• Civitas Investigational Site 1002 — Port Charlotte, Florida, United States
• Civitas Investigational Site 1015 — Tampa, Florida, United States
• Civitas Investigational Site 1007 — Kansas City, Kansas, United States
• Civitas Investigational Site 1010 — Boston, Massachusetts, United States
• Civitas Investigational Site 1001 — Bingham Farms, Michigan, United States
• Civitas Investigational Site 1008 — Roseville, Michigan, United States
• Civitas Investigational Site 1009 — Saint Louis, Michigan, United States
• Civitas Investigational Site 1005 — West Bloomfield, Michigan, United States
• Civitas Investigational Site 1011 — Kingston, New York, United States
• Civitas Investigational Site 1014 — Cleveland, Ohio, United States
• Civitas Investigational Site 1003 — Kirkland, Washington, United States
• Civitas Investigational Site 4003 — Cassino, Italy
• Civitas Investigational Site 4002 — Chieti, Italy
• Civitas Investigational Site 4001 — Rome, Italy
• Civitas Investigational Site 3001 — Belgrade, Serbia
• Civitas Investigational Site 3002 — Belgrade, Serbia
• Civitas Investigational Site 2004 — Cambridge, United Kingdom
• Civitas Investigational Site 200 — Glasgow, United Kingdom
• Civitas Investigational Site 2001 — London, United Kingdom
• Civitas Investigational Site 2003 — Stoke-on-Trent, United Kingdom

Full record on ClinicalTrials.gov

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