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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00642356 |
The purpose of this study is to test the effects of carbidopa/levodopa/entacapone compared to the effects of immediate-release carbidopa/levodopa on end-of-dose wearing off in persons who have Parkinson's disease.
Condition | Intervention | Phase |
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Parkinson's Disease |
Drug: Carbidopa/levodopa/entacapone, IR carbidopa/levodopa |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An 8-Week, Prospective, Randomized, Double-Blind, Double-Dummy, Active-Controlled, Multi-Center Comparison Study of the Effects of Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa on Non-Motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-Motor Symptoms of Wearing |
Enrollment: | 33 |
Study Start Date: | February 2008 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Carbidopa/levodopa/entacapone plus immediate release carbidopa/levodopa placebo
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Drug: Carbidopa/levodopa/entacapone, IR carbidopa/levodopa |
2: Placebo Comparator
Immediate release carbidopa/levodopa plus Carbidopa/levodopa/entacapone placebo
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Drug: Carbidopa/levodopa/entacapone, IR carbidopa/levodopa |
Ages Eligible for Study: | 30 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
moderate or severe major depression, present independent from the time of first diagnosis of Parkinson's Disease, as defined by a Quick Inventory of Depressive Symptomatology -Self Rating 16 score of > 15; or 3. generalized anxiety disorder or panic disorder if made prior to the diagnosis of Parkinson's Disease;
Other protocol-defined inclusion/exclusion criteria may apply
United States, Arizona | |
Xenoscience, Inc | |
Phoenix, Arizona, United States, 85004 | |
United States, California | |
University of California | |
Irvine, California, United States, 92697 | |
Coastal Neurological Medical Group, Inc | |
La Jolla, California, United States, 92037 | |
South Coast Health Center | |
Aliso Viejo, California, United States, 92656 | |
United States, District of Columbia | |
Georgetown University Hospital | |
Washington, District of Columbia, United States, 20007 | |
United States, Florida | |
Sunrise Clinical Research, Inc | |
Hollywood, Florida, United States, 33021 | |
Charlotte Neurological Services | |
Port Charlotte, Florida, United States, 33952 | |
United States, Kansas | |
Cotton O'Neil Clinic | |
Topeka, Kansas, United States, 66606 | |
United States, Maryland | |
University of Maryland School of Medicine | |
Baltimore, Maryland, United States, 21201 | |
United States, Missouri | |
Dr. John's Mercy Medical Center | |
St. Louis, Missouri, United States, 63141 | |
Neurology, Inc | |
Columbia, Missouri, United States, 65201 | |
United States, Nebraska | |
Creighton U Medical Center, Dept of Neurology | |
Omaha, Nebraska, United States, 68131 | |
United States, New York | |
Parkinson's Disease & Movement Disorders | |
Commack, New York, United States, 11725 | |
Neurological Care of Central NY | |
Syracuse, New York, United States, 13210 | |
Central New York Research Corporation | |
Syracuse, New York, United States, 13210 | |
United States, North Carolina | |
Duke University | |
Durham, North Carolina, United States, 27705 | |
United States, Pennsylvania | |
University of Pittsburg | |
Pittsburg, Pennsylvania, United States, 15213 | |
Neurology Associates | |
Monroeville, Pennsylvania, United States, 15146 | |
United States, Texas | |
University of Texas Southwestern | |
Dallas, Texas, United States, 75390 | |
Scott & White Hospital | |
Temple, Texas, United States, 76508 | |
University of Texas Medical School | |
Houston, Texas, United States, 77030 |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CELC200AUS14 |
Study First Received: | March 19, 2008 |
Last Updated: | April 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00642356 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Idiopathic Parkinson's disease carbidopa/levodopa/entacapone non-motor symptoms motor-symptoms |
Neurotransmitter Agents Levodopa Ganglion Cysts Immunologic Factors Basal Ganglia Diseases Carbidopa Adjuvants, Immunologic Central Nervous System Diseases Dopamine Agonists |
Brain Diseases Neurodegenerative Diseases Entacapone Dopamine Parkinson Disease Movement Disorders Sinemet Dopamine Agents Parkinsonian Disorders |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Anti-Dyskinesia Agents Basal Ganglia Diseases Physiological Effects of Drugs Antiparkinson Agents Neurodegenerative Diseases Brain Diseases Dopamine Agonists Movement Disorders Therapeutic Uses Levodopa |
Carbidopa Nervous System Diseases Adjuvants, Immunologic Central Nervous System Diseases Enzyme Inhibitors Pharmacologic Actions Entacapone Parkinson Disease Sinemet Dopamine Agents Parkinsonian Disorders Central Nervous System Agents |