Efficacy and Safety Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes

Completed · Phase 3 · 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. Patients who successfully complete this study will be eligible to enroll into a 12 month treatment extension (CVT-301-004E) study.

Key facts

Study ID

NCT02240030

Run by

Acorda Therapeutics

People needed

351

Starts

2014-11-01

Expected to finish

2016-12-01

Last updated by the study team

2019-05-28

Who can join

Age: 30 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Idiopathic Parkinson's Disease (PD) diagnosed between the ages of 30 and 85 years;
• Hoehn and Yahr Stage 1-3 in an "on" state;
• Require levodopa-containing medication regimen at least 3 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;
• Total daily LD dose <1600 mg/day;
• Able to perform a spirometry maneuver in the ON and OFF states;
• Normal cognition confirmed by MMSE score ≥25

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;
• Known contraindication to the use of levodopa;
• Any significant condition, severe concurrent disease, abnormality or finding that would make patients unsuitable or may compromise patient safety;
• Any contraindication to performing routine spirometry.

Where it is running

• Acorda Site #5042 — Fresno, California, United States
• Acorda Site #5064 — Fullerton, California, United States
• Acorda Site #5035 — Loma Linda, California, United States
• Acorda Site #5027 — Long Beach, California, United States
• Acorda Site #5037 — Los Angeles, California, United States
• Acorda Site #5070 — Pasadena, California, United States
• Acorda Site #5047 — Reseda, California, United States
• Acorda Site #5068 — Santa Ana, California, United States
• Acorda Site #5069 — Torrance, California, United States
• Acorda Site #5052 — Washington D.C., District of Columbia, United States
• Acorda Site #5046 — Atlantis, Florida, United States
• Acorda Site #5053 — Aventura, Florida, United States
• Acorda Site #5013 — Boca Raton, Florida, United States
• Acorda Site #5016 — Jacksonville, Florida, United States
• Acorda Site #5071 — Maitland, Florida, United States
• Acorda Site #5044 — Orlando, Florida, United States
• Acorda Site #5060 — Palm Beach Gardens, Florida, United States
• Acorda Site #5001 — Port Charlotte, Florida, United States
• Acorda Site #5065 — St. Petersburg, Florida, United States
• Acorda Site #5012 — Tampa, Florida, United States
• Acorda Site #5040 — Atlanta, Georgia, United States
• Acorda Site #5025 — Chicago, Illinois, United States
• Acorda Site #5030 — Chicago, Illinois, United States
• Acorda Site #5011 — Elk Grove Village, Illinois, United States
• Acorda Site #5020 — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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