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Official Study Title: A 12-Week, Multi-center, Randomized, Prospective, Open-Label,  Open-labelA trial design that allows the researcher and the study participant to know what treatment the participant is receiving. This is the opposite of double-blind study. Blinded Rater, Crossover Study of the Effects of Immediate-Release 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. Versus Stalevo on Markers of Event-Related Potentials (ERPs) in Patients with Idiopathic  IdiopathicOf, relating to, or designating a disease having no known cause. PD...
Sponsor: Novartis Pharmaceuticals Corporation
Clinicaltrials.gov ID: NCT00601978
Study ID: CELC200AUS15

Summary

The purpose of this study is to test the effects of Stalevo compared to the effects of immediate-release carbidopa/levodopa on the brain in people with idiopathic Parkinson’s disease. This will be done with an EEG (an electroencephalogram), or a machine that measures electrical activity of the brain.

Study Phase

Phase 4
What is a study phase?

Symptoms Addressed: Study does not address symptoms

Study does not address symptoms

Time Commitment

• Less than six months
• Both Screening  ScreeningPeriod of selection of clinical trial participants based on ELIGIBILITY CRITERIA. and Baseline  BaselinBeginning measurements against which a participant’s progress can be quantified at the end of a study. visits will take up to 3 hours to complete. Subsequent visits approximately every 2 to 3 weeks take 1 hour to complete. The visit that occurs at week six takes 7 hours for EEG measurements and blood draws.

Eligibility

• Minimum Age: 45
• Maximum Age: 75
• Gender(s) Accepted: Either

Inclusion Criteria

• Persons who experience re-emergence of PD symptoms during waking hours.
• Persons taking a stable dose of immediate-release carbidopa/levodopa for at least 4 weeks at a dose of 300-600mg/day.

Exclusion Criteria

• Treatment with MAO-A inhibitors (pharmaceuticals that reduce the breakdown of primarily serotonin, epinephrine, and norepinephrine) or neuroleptics (antipsychotic medications).
• Treatment with selegiline.  SelegilineInhibitor that increases the amount of dopamine in the brain to help control the symptoms of Parkinson's in people who are taking levodopa and carbidopa in combination (Sinemet). Selegiline may help people with Parkinson's to decrease the dose of levodopa/carbidopa needed to control symptoms, stopping the effects of levodopa/carbidopa from wearing off between doses, and increasing the length of time that levodopa/carbidopa will continue to control symptoms.
• Persons taking a stable dose of immediate-release carbidopa/levodopa for at least 4 weeks at a dose of 300-600mg/day.
• Treatment with ACE inhibitors (or inhibitors of Angiotensin-Converting Enzyme, pharmaceuticals that are used primarily in treatment of hypertension and congestive heart failure).
• Treatment with anti-coagulants (medications that prevent clots).
• Treatment with oral or inhaled glucocorticoid steroids (any of a group of steroid hormones, such as cortisone, that are produced by the adrenal cortex, are involved in carbohydrate, protein, and fat metabolism, and have anti-inflammatory properties).
• Treatment with dopamine  DopamineA "chemical messenger" that regulates movement by assisting in the effective communication (transmission) of electrochemical signals in the brain from one nerve cell (neuron) to another. As dopamine producing cells degenerate with advancing PD, they no longer produce enough to regulate neurons elsewhere in the brain, resulting in a loss of control of movements, leading to symptoms such as slowed movements, tremor, and rigidity. agonists.

Enrollment

Expected Enrollment: 10 (US)
Date Enrollment Began: Dec 15 2007
Last Updated Date: May 05 2008
Trial Post Date: May 05 2008
Website: http://clinicaltrials.gov/ct2/show/NCT00601978?term=andrew+leuchter&rank=2

Primary Contacts and Locations

California

• Michelle Abrams — Study Coordinator
  UCLA
  mabrams@brain.ucla.edu
  Phone: (310) 825-0797
  760 Westwood Blvd.
  Room 37-426
  Los Angeles, CA 90024
  USA