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Efficacy of Levodopa/Carbidopa/Entacapone vs. Levodopa/Carbidopa in Parkinson's Disease Patients With Early Wearing Off
This study is ongoing, but not recruiting participants.
First Received: October 24, 2006   Last Updated: June 6, 2008   History of Changes
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Unified Parkinson Disease Rating Scale score, Part II (Activities of daily living) at the beginning of the study and at 3 months

Secondary Outcome Measures:
  • Unified Parkinson Disease Rating Scale scores parts I (Mentation, behavior and mood), III (Motor examination), IV (Complications of the treatment) and total score at the beginning of the study and at 3 months
  • Parkinson Disease Questionnaire-39 items at the beginning of the study and at 3 months
  • Global assessments of the treatment, by patient and investigator, at baseline and 3 months

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

Detailed Description:

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
Criteria

Inclusion Criteria:

  1. Male and female patients ages ≥ 30 and ≤ 80 years old.
  2. A clinical diagnosis of idiopathic Parkinson's disease.
  3. Taking a stable dose of levodopa/carbidopa (≥ 300 and ≤ 600mg) for a period of at least 1 month prior to study entry.
  4. Must be using any of the following levodopa/carbidopa standard formulation levodopa/carbidopa 100/25mg dose in any intake of the day

    • 1 full tablet, and/or
    • 1½ tablets The patient can also be using, for a period of at least 1 month prior to study entry, 1 tablet of the controlled release formulation of levodopa/carbidopa 100/25 mg (marketed in Spain as Sinemet Plus retard) or 1 tablet the controlled release formulation of levodopa/carbidopa 200/50 mg (marketed in Spain as Sinemet retard) in each intake, at different doses.
  5. Must have early end-of-dose wearing-off defined by >= 2 or <=7 positive responses to the QUICK questionnaire.
  6. Must have a minimum UPDRS part II (ADL) score of 9.
  7. Patients without dyskinesia or with mild dyskinesia.
  8. Female patients must be either post-menopausal or using one or more acceptable methods of contraception
  9. Must be capable of satisfying the requirements of the protocol and must be willing and able to give informed consent according to legal requirements

Exclusion Criteria:

  1. Previous or current use of entacapone.
  2. History, signs, or symptoms suggesting the diagnosis of secondary or atypical parkinsonism.
  3. Unstable Parkinson's disease patients
  4. Patients who experience severe dyskinesia
  5. The following levodopa/carbidopa doses and strengths are not permitted:

    • Patients taking ½ tablet of standard formulation levodopa/carbidopa 100/25
    • Patients taking standard formulation levodopa/carbidopa 100/10 or 250/25
    • Patients taking fewer than 3 or more than 6 daily intakes of standard formulation levodopa/carbidopa 100/25 (fewer than 300mg or more than 600mg of levodopa)
  6. Patients with hallucinations or psychiatric diseases related to levodopa or dopamine agonists intake. Patients with major depression.
  7. Female patients who are pregnant, trying to become pregnant or nursing (lactating) an infant.
  8. Concomitant treatment with MAO-inhibitors (except selegiline up to 10mg/day), rotigotine or neuroleptics, within 60 days prior to the screening visit
  9. Patients with a previous history of Neuroleptic Malignant Syndrome (NMS) and/or non-traumatic rhabdomyolysis
  10. Participated in another trial of an investigational drug/device within the last 30 days prior to study entry
  11. Patients who have a history of poor compliance or are in the Investigator's judgment unlikely to comply with medical regimens or study requirements
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00391898

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
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Eduard Tolosa-Sarró, Dr. Hospital Clínic i Provincial de Barcelona
  More Information

No publications provided

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

Keywords provided by Novartis:
Parkinson's disease, adults, levodopa/carbidopa/entacapone, wearing-off, activities of daily living

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on July 02, 2009