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Evaluating Effects of Carbidopa/Levodopa/Entacapone On Motor Function And Quality of Life In People with Parkinson's Disease

Official Study Title: Evaluating Effects of Carbidopa/ CarbidopaDrug given in combination with levodopa to ensure that more of the latter reaches the brain and changes into dopamine, rather than being broken down in the bloodstream. This allows for lower doses of levodopa to be used, reducing the risk of nausea, vomiting, and other side effects. Levodopa/ LevodopaA compound that is converted into dopamine (the brain chemical which is deficient in people with Parkinson's) in the brain. Entacapone On Motor Function And Quality of Life In People with Parkinson's Disease
Sponsor: Novartis Pharmaceuticals Corporation
Clinicaltrials.gov ID: NCT00219284
Study ID: CELC200AUS11

Summary

The purpose of this study is to examine changes in motor function and quality of life in people with Parkinson's disease Parkinson's DiseaseA chronic, slowly progressive disease of the nervous system characterized by the combination of tremor, rigidity, bradykinesia and stooped posture, among other symptoms. who are being treated with Stalevo, a newer Parkinson's disease medication, containing carbidopa (a medication that reduces the side effects Side Effects Any undesired actions or effects of a drug or treatment. Negative or adverse effects may include such symptoms as headache, nausea and upset stomach. In some cases, side-effects may cause more severe medical problems. of levodopa)/levodopa/entacapone (which extends the benefits of levodopa).

Study Phase

Phase 4
What is a study phase?

Symptoms Addressed: Movement Symptoms

Slowness of movement (bradykinesia) BradykinesiaSlowness of movement. , Loss of Motor Skills

Time Commitment

Less than six months
16 weeks, with an optional 8-week extension phase. 5 physician office visits and 2 telephone interviews within the 16-week study; one additional office visit and telephone interview in the optional 8-week extension phase

Eligibility

Minimum Age: 30
Maximum Age: 80
Gender(s) Accepted: Either

Inclusion Criteria

Clinical ClinicalDealing with or based on observation and treatment of people, as opposed to basic science carried out in the laboratory or in animals. diagnosis of Parkinson's disease
Taking regular doses of immediate release carbidopa/levodopa

Enrollment

Expected Enrollment: 360 (US)
Date Enrollment Began: Jan 01 2006
Last Updated Date: Feb 19 2006
Trial Post Date: Feb 19 2006
Website: http://www.novartisclinicaltrials.com/etrials/searchTrial.do?trialID=401