Carbidopa/Levodopa/Entacapone Versus Immediate Release (IR) Carbidopa/Levodopa on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-motor Symptoms of Wearing Off

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Parkinson's Disease

In brief

The purpose of this study is to test the effects of carbidopa/levodopa/entacapone compared to the effects of immediate-release carbidopa/levodopa on non-motor symptoms of end-of-dose wearing off in persons who have Parkinson's disease.

Key facts

Study ID

NCT00642356

Run by

Novartis

People needed

14

Starts

2008-03-01

Expected to finish

2009-05-01

Last updated by the study team

2011-02-18

Who can join

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

You may qualify if…

• Be aged 30 to 85 years.
• Be male or female - female patients must be either not of childbearing potential (defined as post menopausal for at least one year or surgically incapable of bearing children), or must be practicing contraceptive methods as outlined in the protocol.
• Have a clinical diagnosis of idiopathic Parkinson's Disease, exhibiting at least 2 of 3 symptoms (rigidity, resting tremor, bradykinesia)
• Have non-motor symptoms of end of dose wearing off i.e., the presence of at least one non-motor symptom of Parkinson's Disease which improves with the next immediate release (IR) carbidopa/levodopa dose as determined by the Quantitative Wearing-Off Questionnaire 9 and investigator's assessment. At least one non-motor item has to show a severity of at least 2 points (of a maximum of 4) and show an improvement of at least 1 one hour after immediate release (IR) carbidopa/levodopa administration. Also there should not have been a deterioration of 1 point or more in another non-motor item.(all criteria must be fulfilled)
• Be taking a stable dose of immediate release (IR) carbidopa/levodopa for at least 21 days prior to randomization at an equivalent total daily dose of immediate release (IR) carbidopa/levodopa between 300 to 800 mg. Dosing should be either 3 to 6 times per day.

You may not qualify if…

• Have a previous history of being non-responsive to entacapone or tolcapone treatment or having experienced a serious or severe adverse event(s) which resulted in the discontinuation of treatment from the previous use of entacapone or tolcapone; current treatment with entacapone or tolcapone or discontinued treatment with either therapy or discontinued less than 60 days before randomization;
• Have a history, signs, or symptoms suggesting a diagnosis of secondary or atypical parkinsonism;
• Have unstable Parkinson's Disease requiring frequent booster doses;
• Disabling dyskinesias, indicated by a score of greater than 1 on Unified Parkinson Disease Rating Scale question #32, or a score of greater than 1 on Unified Parkinson Disease Rating Scale question #33;
• Have a history or current diagnosis of psychotic features according to the investigator;
• Other protocol-defined inclusion/exclusion criteria applied to the study.

Where it is running

• Xenoscience, Inc — Phoenix, Arizona, United States
• South Coast Health Center — Aliso Viejo, California, United States
• University of California — Irvine, California, United States
• Coastal Neurological Medical Group, Inc — La Jolla, California, United States
• Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Sunrise Clinical Research, Inc — Hollywood, Florida, United States
• Charlotte Neurological Services — Port Charlotte, Florida, United States
• Cotton O'Neil Clinic — Topeka, Kansas, United States
• University of Maryland School of Medicine — Baltimore, Maryland, United States
• Neurology, Inc — Columbia, Missouri, United States
• Dr. John's Mercy Medical Center — St Louis, Missouri, United States
• Creighton U Medical Center, Dept of Neurology — Omaha, Nebraska, United States
• Parkinson's Disease & Movement Disorders — Commack, New York, United States
• Central New York Research Corporation — Syracuse, New York, United States
• Neurological Care of Central NY — Syracuse, New York, United States
• Duke University — Durham, North Carolina, United States
• Neurology Associates — Monroeville, Pennsylvania, United States
• University of Pittsburg — Pittsburgh, Pennsylvania, United States
• University of Texas Southwestern — Dallas, Texas, United States
• University of Texas Medical School — Houston, Texas, United States
• Scott & White Hospital — Temple, Texas, United States

Full record on ClinicalTrials.gov

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