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| Sponsor: | Novartis |
|---|---|
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00642356 |
Purpose
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 |
|---|---|---|
|
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
|
Drug: Carbidopa/levodopa/entacapone, IR carbidopa/levodopa |
|
2: Placebo Comparator
Immediate release carbidopa/levodopa plus Carbidopa/levodopa/entacapone placebo
|
Drug: Carbidopa/levodopa/entacapone, IR carbidopa/levodopa |
Eligibility| Ages Eligible for Study: | 30 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations| 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 |
More Information
| 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 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 |