Back to resultsEfficacy of Levodopa/Carbidopa/Entacapone vs Levodopa/Carbidopa in Parkinson's Disease Patients With Early Wearing-off
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Levodopa/carbidopa/entacapone
Levodopa/carbidopa
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, adults, levodopa/carbidopa/entacapone, wearing-off, activities of daily living
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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.
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Hospital Universitario Principe de Asturias
- Fundación Hospital de Alcorcón
- Hospital General de Alicante
- Centro Médico Teknon
- Hospital de la Santa Creu i de Sant Pau
- Hospital Vall d'Hebron
- Hospital Clínic i Provincial de Barcelona
- Corporació Sanitària Parc Taulí Sabadell
- Hospital General Yagüe
- Hospital Universitario Virgen de las Nieves
- Hospital Universitari Bellvitge Princeps d'Espanya
- Hospital Juan Canalejo
- Clínica Ruber
- Hospital General Universitario Gregorio Marañon
- Fundación Jiménez Díaz
- Hospital Clínico San Carlos
- Hospital 12 de Octubre
- Hospital Universitario La Paz
- Universitaria de Navarra
- Policlínica Gipuzkoa
- Hospital General de Catalunya
- Hospital Universitario Virgen del Rocio
- Hospital Mutua de Terrassa
- Hospital Universitario de la Fe
- Hospital Clínico Universitario de Valencia
- Hospital Gral. de Valencia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Levodopa/carbidopa/entacapone
Levodopa/carbidopa
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in the UPDRS Part I (Mentation, Behavior, and Mood) 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 I (items 1-4; total score 0-16, calculated as the sum of the individual items) measures the patient's mentation, mood and behavior. A lower total score indicates greater symptom control. A negative change score indicates improvement.
Change in the UPDRS Part III (Motor Function) 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 III (items 18-31; total score 0-56, calculated as the sum of the individual items) measures the patient's motor function. A lower total score indicates greater symptom control. A negative change score indicates improvement.
Change in the UPDRS Part IV (Complications of Therapy) Score From Baseline to Month 3
Part IV of the UPDRS measures complications the patient may be experiencing with therapy and was only collected at and after the visit at which the first dyskinesia or episode of wearing-off was recorded. Part IV is composed of 3 sections and 11 items: A (32-35, dyskinesia), B (36-39, clinical fluctuations, C (40-42, other complications) (total score 0-23, calculated as the sum of the individual items). A lower total score indicates greater symptom control. A negative change score indicates improvement.
Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to Month 3
The PDQ-39 is an instrument used to assess quality of life in individuals with Parkinson's disease. The questionnaire provides scores on eight scales: Mobility, activities of daily living, emotions, stigma, social support, cognitions, communication, and bodily discomfort. Questions are scored on a 5-point Likert scale ranging from 1 (never) to 3 (sometimes) to 5 (always). The total score can range from 39 to 195. A lower score indicates better quality of life. A positive change score indicates an improvement.
Patient and Investigator Global Evaluation of the Patient
Both the patient and the investigator made an evaluation of the change in the patient's condition by rating the condition of the patient at the end of the study compared to patient's condition at baseline. The rating was made on a scale ranging from -3 to +3: (-3: Very much improved, -2: much improved, -1: mild improvement, 0: no change, +1: mild deterioration, +2: much deterioration, +3: very much deterioration). A negative score indicates improvement.
Change on the QUICK Questionnaire (QQ) Score From Baseline to Month 3
The QQ is a self-administered questionnaire that includes 19 wearing-off (WO) symptoms (motor and non-motor). A positive answer to each of the 19 symptoms is given by patients if they presented with a symptom and the symptom disappeared after the next drug dose. Two positive answers are diagnostic of wearing-off (WO). A negative change score indicates improvement.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00391898
Brief Title
Efficacy of Levodopa/Carbidopa/Entacapone vs Levodopa/Carbidopa in Parkinson's Disease Patients With Early Wearing-off
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, adults, levodopa/carbidopa/entacapone, wearing-off, activities of daily living
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
95 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Levodopa/carbidopa/entacapone
Arm Type
Experimental
Arm Title
Levodopa/carbidopa
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Levodopa/carbidopa/entacapone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Levodopa/carbidopa
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living [ADL]) Score From Baseline to Month 3
Description
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.
Time Frame
Baseline to end of study (Month 3)
Secondary Outcome Measure Information:
Title
Change in the UPDRS Part I (Mentation, Behavior, and Mood) Score From Baseline to Month 3
Description
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 I (items 1-4; total score 0-16, calculated as the sum of the individual items) measures the patient's mentation, mood and behavior. A lower total score indicates greater symptom control. A negative change score indicates improvement.
Time Frame
Baseline to end of study (Month 3)
Title
Change in the UPDRS Part III (Motor Function) Score From Baseline to Month 3
Description
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 III (items 18-31; total score 0-56, calculated as the sum of the individual items) measures the patient's motor function. A lower total score indicates greater symptom control. A negative change score indicates improvement.
Time Frame
Baseline to end of study (Month 3)
Title
Change in the UPDRS Part IV (Complications of Therapy) Score From Baseline to Month 3
Description
Part IV of the UPDRS measures complications the patient may be experiencing with therapy and was only collected at and after the visit at which the first dyskinesia or episode of wearing-off was recorded. Part IV is composed of 3 sections and 11 items: A (32-35, dyskinesia), B (36-39, clinical fluctuations, C (40-42, other complications) (total score 0-23, calculated as the sum of the individual items). A lower total score indicates greater symptom control. A negative change score indicates improvement.
Time Frame
Baseline to end of study (Month 3)
Title
Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to Month 3
Description
The PDQ-39 is an instrument used to assess quality of life in individuals with Parkinson's disease. The questionnaire provides scores on eight scales: Mobility, activities of daily living, emotions, stigma, social support, cognitions, communication, and bodily discomfort. Questions are scored on a 5-point Likert scale ranging from 1 (never) to 3 (sometimes) to 5 (always). The total score can range from 39 to 195. A lower score indicates better quality of life. A positive change score indicates an improvement.
Time Frame
Baseline to end of study (Month 3)
Title
Patient and Investigator Global Evaluation of the Patient
Description
Both the patient and the investigator made an evaluation of the change in the patient's condition by rating the condition of the patient at the end of the study compared to patient's condition at baseline. The rating was made on a scale ranging from -3 to +3: (-3: Very much improved, -2: much improved, -1: mild improvement, 0: no change, +1: mild deterioration, +2: much deterioration, +3: very much deterioration). A negative score indicates improvement.
Time Frame
Baseline to end of study (Month 3)
Title
Change on the QUICK Questionnaire (QQ) Score From Baseline to Month 3
Description
The QQ is a self-administered questionnaire that includes 19 wearing-off (WO) symptoms (motor and non-motor). A positive answer to each of the 19 symptoms is given by patients if they presented with a symptom and the symptom disappeared after the next drug dose. Two positive answers are diagnostic of wearing-off (WO). A negative change score indicates improvement.
Time Frame
Baseline to end of study (Month 3)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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.
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduard Tolosa-Sarró, Dr.
Organizational Affiliation
Hospital Clínic i Provincial de Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Principe de Asturias
City
Alcalá de Henares, Madrid
ZIP/Postal Code
28805
Country
Spain
Facility Name
Fundación Hospital de Alcorcón
City
Alcorcón (Madrid
ZIP/Postal Code
28922
Country
Spain
Facility Name
Hospital General de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Centro Médico Teknon
City
Barcelona
ZIP/Postal Code
08022
Country
Spain
Facility Name
Hospital de la Santa Creu i de Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Clínic i Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Corporació Sanitària Parc Taulí Sabadell
City
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital General Yagüe
City
Burgos
ZIP/Postal Code
09005
Country
Spain
Facility Name
Hospital Universitario Virgen de las Nieves
City
Granada
ZIP/Postal Code
18012
Country
Spain
Facility Name
Hospital Universitari Bellvitge Princeps d'Espanya
City
L'Hospitalet de Llobregat , Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Juan Canalejo
City
La Coruña
ZIP/Postal Code
15002
Country
Spain
Facility Name
Clínica Ruber
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Fundación Jiménez Díaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Universitaria de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Policlínica Gipuzkoa
City
San Sebastian
ZIP/Postal Code
20009
Country
Spain
Facility Name
Hospital General de Catalunya
City
Sant Cugat del Valles, Barcelona
ZIP/Postal Code
08195
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Mutua de Terrassa
City
Terrassa, Barcelona
ZIP/Postal Code
08221
Country
Spain
Facility Name
Hospital Universitario de la Fe
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Hospital Clínico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Gral. de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Levodopa/Carbidopa/Entacapone vs Levodopa/Carbidopa in Parkinson's Disease Patients With Early Wearing-off
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