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| Sponsored by: |
Novartis |
|---|---|
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00391898 |
Purpose
The study will evaluate the efficacy of levodopa/carbidopa/entacapone vs. levodopa/carbidopa in patients with Parkinson's disease and early wearing off with levodopa
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson's Disease |
Drug: Levodopa/carbidopa/entacapona |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A 3-Month, Multicenter, Double-Blind, Randomized Study to Evaluate the Efficacy of Levodopa/Carbidopa/Entacapone vs. Levodopa/Carbidopa in Parkinson's Disease Patients With Impairment of Activities of Daily Living and Early Wearing Off With Levodopa |
| Estimated Enrollment: | 200 |
| Study Start Date: | October 2006 |
| Estimated Study Completion Date: | June 2008 |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Levodopa/carbidopa/entacapone
|
Drug: Levodopa/carbidopa/entacapona |
|
2: Active Comparator
Levodopa/carbidopa
|
Drug: Levodopa/carbidopa/entacapona |
The study will evaluate the efficacy of levodopa/carbidopa/entacapone vs. levodopa/carbidopa in patients with Parkinson's disease and early wearing off with levodopa
Eligibility| Ages Eligible for Study: | 30 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Must be using any of the following levodopa/carbidopa standard formulation levodopa/carbidopa 100/25mg dose in any intake of the day
Exclusion Criteria:
The following levodopa/carbidopa doses and strengths are not permitted:
Contacts and Locations| Spain | |
| Hospital Clínic i Provincial de Barcelona | |
| Barcelona, Spain, 08036 | |
| Universitaria de Navarra | |
| Pamplona, Spain, 31008 | |
| Policlínica Gipuzkoa | |
| San Sebastian, Spain, 20009 | |
| Hospital Universitari Bellvitge Princeps d'Espanya | |
| L'Hospitalet de Llobregat , Barcelona, Spain, 08907 | |
| Hospital General de Catalunya | |
| Sant Cugat del Valles, Barcelona, Spain, 08195 | |
| Hospital Vall d'Hebron | |
| Barcelona, Spain, 08025 | |
| Hospital Mutua de Terrassa | |
| Terrassa, Barcelona, Spain, 08221 | |
| Centro Médico Teknon | |
| Barcelona, Spain, 08022 | |
| Hospital de la Santa Creu i de Sant Pau | |
| Barcelona, Spain, 08025 | |
| Hospital Universitario de la Fe | |
| Valencia, Spain, 46009 | |
| Hospital Clínico San Carlos | |
| Madrid, Spain, 28040 | |
| Clínica Ruber | |
| Madrid, Spain, 28006 | |
| Hospital General Universitario Gregorio Marañon | |
| Madrid, Spain, 28007 | |
| Corporació Sanitària Parc Taulí Sabadell | |
| Barcelona, Spain, 08208 | |
| Fundación Hospital de Alcorcón | |
| Alcorcón (Madrid, Spain, 28922 | |
| Hospital Universitario La Paz | |
| Madrid, Spain, 28046 | |
| Hospital Universitario Virgen del Rocio | |
| Sevilla, Spain, 41013 | |
| Hospital Universitario Virgen de las Nieves | |
| Granada, Spain, 18012 | |
| Hospital General de Alicante | |
| Alicante, Spain, 03010 | |
| Hospital General Yagüe | |
| Burgos, Spain, 09005 | |
| Hospital Juan Canalejo | |
| La Coruña, Spain, 15002 | |
| Fundación Jiménez Díaz | |
| Madrid, Spain, 28040 | |
| Hospital Clínico Universitario de Valencia | |
| Valencia, Spain, 46010 | |
| Hospital 12 de Octubre | |
| Madrid, Spain, 28041 | |
| Hospital Gral. de Valencia | |
| Valencia, Spain, 46014 | |
| Hospital Universitario Principe de Asturias | |
| Alcalá de Henares, Madrid, Spain, 28805 | |
| Principal Investigator: | Eduard Tolosa-Sarró, Dr. | Hospital Clínic i Provincial de Barcelona |
More Information
| Responsible Party: | Novartis Pharmaceuticals ( External Affairs ) |
| Study ID Numbers: | CELC200AES03 |
| Study First Received: | October 24, 2006 |
| Last Updated: | June 6, 2008 |
| ClinicalTrials.gov Identifier: | NCT00391898 History of Changes |
| Health Authority: | Spain: Agencia Española del Medicamento y Productos Sanitarios. Ministerio de Sanidad y Consumo |
|
Parkinson's disease, adults, levodopa/carbidopa/entacapone, wearing-off, activities of daily living |
|
Neurotransmitter Agents Levodopa Ganglion Cysts Basal Ganglia Diseases Carbidopa Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases |
Entacapone Dopamine Parkinson Disease Movement Disorders Sinemet Dopamine Agents Parkinsonian Disorders |
|
Neurotransmitter Agents Levodopa Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Basal Ganglia Diseases Nervous System Diseases Carbidopa Central Nervous System Diseases Antiparkinson Agents Enzyme Inhibitors |
Brain Diseases Neurodegenerative Diseases Pharmacologic Actions Entacapone Parkinson Disease Movement Disorders Therapeutic Uses Dopamine Agents Parkinsonian Disorders Central Nervous System Agents |