Randomized Safety Study of CVT-301 Compared to an Observational Control Group

Completed · Phase 3

Conditions studied: Idiopathic Parkinson's Disease

In brief

This study is a 12-month, open-label, randomized, multicenter study which will evaluate the safety and efficacy of CVT-301 for the treatment of up to 5 OFF episodes per day in Parkinson's Disease (PD) patients experiencing motor fluctuations (OFF episodes) and will include a concurrent observational cohort of PD patients managed using the usual standards of care.

Key facts

Study ID

NCT02352363

Run by

Acorda Therapeutics

People needed

408

Starts

2015-03-01

Expected to finish

2017-05-01

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…

• Has signed and dated an Internal Review Board/Independent Ethics Committee (IRB/IEC)-approved informed consent form before any protocol-specific screening procedures are performed.
• Women of child-bearing potential must use protocol-defined contraceptive measures and must have a negative serum human chorionic gonadotropin (hCG) test at screening. These patients must be willing to remain on their current form of contraception for the duration of the study.
• Patients who have idiopathic PD (i.e., not induced by drugs or other diseases) as defined by fulfilling Steps 1 and 2 of the United Kingdom (UK) Brain Bank criteria, diagnosed after the age of 30 years.
• Patients who are classified as Stage 1 to 3 (in the ON state) on the modified Hoehn and Yahr scale for staging of PD severity.
• Patients who have experienced motor fluctuations for a minimum of 2 hours of average daily OFF time per waking day (excluding early morning OFF time) by self-report and confirmed by the PD Diary (on 3 consecutive days) during the screening period.

You may not qualify if…

• Patients who have dyskinesia of a severity that would significantly interfere with their ability to participate or perform study procedures.
• Pregnant or lactating females or females wishing to become pregnant.
• Patients who have any known contraindication to the use of levodopa (LD), including a history of malignant melanoma or a history of narrow-angle glaucoma.
• Patients who have had previous surgery for PD (including but not limited to deep brain stimulation [DBS] or cell transplantation).
• Patients with a history of psychotic symptoms requiring treatment, or suicide ideation or attempt within the prior 12 months.

Where it is running

• Acorda Site # 7142 — Fountain Valley, California, United States
• Acorda Site #7139 — Panorama City, California, United States
• Acorda Site #7141 — Sunnyvale, California, United States
• Acorda Site #7137 — Ormond Beach, Florida, United States
• Acorda Site #7135 — St. Petersburg, Florida, United States
• Acorda Site #7130 — Sunrise, Florida, United States
• Acorda Site #7133 — Atlanta, Georgia, United States
• Acorda Site #7134 — Atlanta, Georgia, United States
• Acorda Site #7131 — Decatur, Georgia, United States
• Acorda Site #7138 — Honolulu, Hawaii, United States
• Acorda Site #7140 — Des Moines, Iowa, United States
• Acorda Site #7150 — Baton Rouge, Louisiana, United States
• Acorda Site #7148 — Toledo, Ohio, United States
• Acorda Site #7004 — Innsbruck, Austria
• Acorda Site #7002 — Linz, Austria
• Acorda Site #7003 — Vienna, Austria
• Acorda Site #7011 — Brussels, Belgium
• Acorda Site #7012 — Edegem, Belgium
• Acorda Site #7013 — Ghent, Belgium
• Acorda Site #7024 — Choceň, Czechia
• Acorda Site #7025 — Ostrava, Czechia
• Acorda Site #7021 — Pardubice, Czechia
• Acorda Site #7022 — Prague, Czechia
• Acorda Site #7023 — Rychnov nad Kněžnou, Czechia
• Acorda Site #7145 — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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