Efficacy of Levodopa/Carbidopa/Entacapone vs Levodopa/Carbidopa in Parkinson's Disease Patients With Early Wearing-off
A 3-month, Multi-center, 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
1 other identifier
interventional
95
1 country
26
Brief Summary
The study evaluated the efficacy of levodopa/carbidopa/entacapone vs levodopa/carbidopa in patients with Parkinson's disease and early wearing-off with levodopa
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2006
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 24, 2006
CompletedFirst Posted
Study publicly available on registry
October 25, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedResults Posted
Study results publicly available
March 15, 2011
CompletedMarch 15, 2011
February 1, 2011
1.7 years
October 24, 2006
January 4, 2011
February 16, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living [ADL]) Score From Baseline to Month 3
The UPDRS is a standardized assessment scale used to measure a patient's disease state. It is completed by a blinded rater. There are 6 parts to the UPDRS. Part II (items 5-17; total score 0-52, calculated as the sum of the individual items) measures the patient's activities of daily living. A lower total score indicates greater symptom control. A negative change score indicates improvement.
Baseline to end of study (Month 3)
Secondary Outcomes (6)
Change in the UPDRS Part I (Mentation, Behavior, and Mood) Score From Baseline to Month 3
Baseline to end of study (Month 3)
Change in the UPDRS Part III (Motor Function) Score From Baseline to Month 3
Baseline to end of study (Month 3)
Change in the UPDRS Part IV (Complications of Therapy) Score From Baseline to Month 3
Baseline to end of study (Month 3)
Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to Month 3
Baseline to end of study (Month 3)
Patient and Investigator Global Evaluation of the Patient
Baseline to end of study (Month 3)
- +1 more secondary outcomes
Study Arms (2)
Levodopa/carbidopa/entacapone
EXPERIMENTALLevodopa/carbidopa
ACTIVE COMPARATORInterventions
Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
Eligibility Criteria
You may qualify if:
- Male and female patients ages ≥ 30 and ≤ 80 years old.
- A clinical diagnosis of idiopathic Parkinson's disease.
- Taking a stable dose of levodopa/carbidopa (≥ 300 and ≤ 600mg) for a period of at least 1 month prior to study entry.
- Must be using any of the following levodopa/carbidopa standard formulation levodopa/carbidopa 100/25mg dose in any intake of the day.
- full tablet, and/or
- ½ 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.
- Must have early end-of-dose wearing-off defined by \>= 2 or \<=7 positive responses to the QUICK questionnaire.
- Must have a minimum UPDRS part II (ADL) score of 9.
- Patients without dyskinesia or with mild dyskinesia.
- Female patients must be either post-menopausal or using one or more acceptable methods of contraception.
- Must be capable of satisfying the requirements of the protocol and must be willing and able to give informed consent according to legal requirements.
You may not qualify if:
- Previous or current use of entacapone.
- History, signs, or symptoms suggesting the diagnosis of secondary or atypical parkinsonism.
- Unstable Parkinson's disease patients.
- Patients who experience severe dyskinesia.
- 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)
- Patients with hallucinations or psychiatric diseases related to levodopa or dopamine agonists intake. Patients with major depression.
- Female patients who are pregnant, trying to become pregnant or nursing (lactating) an infant.
- Concomitant treatment with MAO-inhibitors (except selegiline up to 10mg/day), rotigotine or neuroleptics, within 60 days prior to the screening visit.
- Patients with a previous history of Neuroleptic Malignant Syndrome (NMS) and/or non-traumatic rhabdomyolysis.
- Participated in another trial of an investigational drug/device within the last 30 days prior to study entry.
- Patients who have a history of poor compliance or are in the Investigator's judgment unlikely to comply with medical regimens or study requirements.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (26)
Hospital Juan Canalejo
A Coruña, 15002, Spain
Hospital Universitario Principe de Asturias
Alcalá de Henares, Madrid, 28805, Spain
Fundación Hospital de Alcorcón
Alcorcón (Madrid, 28922, Spain
Hospital General de Alicante
Alicante, 03010, Spain
Centro Médico Teknon
Barcelona, 08022, Spain
Hospital de la Santa Creu i de Sant Pau
Barcelona, 08025, Spain
Hospital Vall d'Hebron
Barcelona, 08025, Spain
Hospital Clínic i Provincial de Barcelona
Barcelona, 08036, Spain
Corporació Sanitària Parc Taulí Sabadell
Barcelona, 08208, Spain
Hospital General Yagüe
Burgos, 09005, Spain
Policlínica Gipuzkoa
Donostia / San Sebastian, 20009, Spain
Hospital Universitario Virgen de las Nieves
Granada, 18012, Spain
Hospital Universitari Bellvitge Princeps d'Espanya
L'Hospitalet de Llobregat , Barcelona, 08907, Spain
Clínica Ruber
Madrid, 28006, Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28007, Spain
Fundación Jiménez Díaz
Madrid, 28040, Spain
Hospital Clínico San Carlos
Madrid, 28040, Spain
Hospital 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Universitaria de Navarra
Pamplona, 31008, Spain
Hospital General de Catalunya
Sant Cugat Del Valles, Barcelona, 08195, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Hospital Mutua de Terrassa
Terrassa, Barcelona, 08221, Spain
Hospital Universitario de la Fe
Valencia, 46009, Spain
Hospital Clínico Universitario de Valencia
Valencia, 46010, Spain
Hospital Gral. de Valencia
Valencia, 46014, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- PRINCIPAL INVESTIGATOR
Eduard Tolosa-Sarró, Dr.
Hospital Clínic i Provincial de Barcelona
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 24, 2006
First Posted
October 25, 2006
Study Start
October 1, 2006
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
March 15, 2011
Results First Posted
March 15, 2011
Record last verified: 2011-02