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Efficacy of Levodopa/Carbidopa/Entacapone vs Levodopa/Carbidopa in Parkinson's Disease Patients With Early Wearing-off

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ClinicalTrials.gov Identifier: NCT00391898
Recruitment Status : Completed
First Posted : October 25, 2006
Results First Posted : March 15, 2011
Last Update Posted : March 15, 2011
Sponsor:
Information provided by:
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Parkinson's Disease
Interventions Drug: Levodopa/carbidopa/entacapone
Drug: Levodopa/carbidopa
Enrollment 95
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Levodopa/Carbidopa/Entacapone Levodopa/Carbidopa
Hide Arm/Group 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. 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.
Period Title: Overall Study
Started 46 [1] 49
Completed 35 39
Not Completed 11 10
Reason Not Completed
Adverse Event             3             0
Other             8             10
[1]
Safety population for Levodopa/carbidopa/entacapone is 45, for Levodopa/carbidopa, per randomized.
Arm/Group Title Levodopa/Carbidopa/Entacapone Levodopa/Carbidopa Total
Hide Arm/Group 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 45 49 94
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants 49 participants 94 participants
66.40  (8.18) 66.45  (9.04) 66.43  (8.59)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 49 participants 94 participants
Female
25
  55.6%
22
  44.9%
47
  50.0%
Male
20
  44.4%
27
  55.1%
47
  50.0%
[1]
Measure Description: Baseline Measure based on Safety population
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
Spain Number Analyzed 45 participants 49 participants 94 participants
45 49 94
[1]
Measure Description: Baseline measure based on safety population.
1.Primary Outcome
Title Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living [ADL]) Score From Baseline to Month 3
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol set with the last observation carried forward (LOCF)
Arm/Group Title Levodopa/Carbidopa/Entacapone Levodopa/Carbidopa
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 35 36
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-2.5  (2.8) -0.5  (3.0)
2.Secondary Outcome
Title Change in the UPDRS Part I (Mentation, Behavior, and Mood) Score From Baseline to Month 3
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol set with LOCF
Arm/Group Title Levodopa/Carbidopa/Entacapone Levodopa/Carbidopa
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 35 36
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-0.5  (1.6) -0.2  (1.0)
3.Secondary Outcome
Title Change in the UPDRS Part III (Motor Function) Score From Baseline to Month 3
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol set with LOCF
Arm/Group Title Levodopa/Carbidopa/Entacapone Levodopa/Carbidopa
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 35 36
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-4.0  (4.6) -1.42  (5.5)
4.Secondary Outcome
Title Change in the UPDRS Part IV (Complications of Therapy) Score From Baseline to Month 3
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol set with LOCF
Arm/Group Title Levodopa/Carbidopa/Entacapone Levodopa/Carbidopa
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 35 36
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-0.6  (1.8) -0.1  (1.3)
5.Secondary Outcome
Title Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to Month 3
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol set with LOCF
Arm/Group Title Levodopa/Carbidopa/Entacapone Levodopa/Carbidopa
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 35 36
Mean (Standard Deviation)
Unit of Measure: Units on a scale
6.3  (20.4) 0.8  (15.6)
6.Secondary Outcome
Title Patient and Investigator Global Evaluation of the Patient
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol set with LOCF
Arm/Group Title Levodopa/Carbidopa/Entacapone Levodopa/Carbidopa
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 34 35
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Patient global evaluation -0.9  (1.1) -0.4  (1.2)
Investigator global evaluation -0.9  (1.0) -0.3  (0.9)
7.Secondary Outcome
Title Change on the QUICK Questionnaire (QQ) Score From Baseline to Month 3
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol set with LOCF
Arm/Group Title Levodopa/Carbidopa/Entacapone Levodopa/Carbidopa
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 35 36
Mean (Standard Deviation)
Unit of Measure: Positive answers
-0.6  (1.8) -0.6  (2.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Levodopa/Carbidopa/Entacapone Levodopa/Carbidopa
Hide Arm/Group 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. 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.
All-Cause Mortality
Levodopa/Carbidopa/Entacapone Levodopa/Carbidopa
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Levodopa/Carbidopa/Entacapone Levodopa/Carbidopa
Affected / at Risk (%) Affected / at Risk (%)
Total   1/45 (2.22%)   1/49 (2.04%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1  1/45 (2.22%)  0/49 (0.00%) 
Psychiatric disorders     
Delusion  1  0/45 (0.00%)  1/49 (2.04%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Levodopa/Carbidopa/Entacapone Levodopa/Carbidopa
Affected / at Risk (%) Affected / at Risk (%)
Total   10/45 (22.22%)   3/49 (6.12%) 
Gastrointestinal disorders     
Retching  1  3/45 (6.67%)  2/49 (4.08%) 
Nervous system disorders     
Dyskinesia  1  7/45 (15.56%)  1/49 (2.04%) 
Psychiatric disorders     
Anxiety  1  5/45 (11.11%)  0/49 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862 778-8300
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00391898     History of Changes
Other Study ID Numbers: CELC200AES03
First Submitted: October 24, 2006
First Posted: October 25, 2006
Results First Submitted: January 4, 2011
Results First Posted: March 15, 2011
Last Update Posted: March 15, 2011