Trial Outcomes & Findings for Efficacy of Levodopa/Carbidopa/Entacapone vs Levodopa/Carbidopa in Parkinson's Disease Patients With Early Wearing-off (NCT NCT00391898)
NCT ID: NCT00391898
Last Updated: 2011-03-15
Results Overview
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.
COMPLETED
PHASE4
95 participants
Baseline to end of study (Month 3)
2011-03-15
Participant Flow
Participant milestones
| Measure |
Levodopa/Carbidopa/Entacapone
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.
|
Levodopa/Carbidopa
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 Study
STARTED
|
46
|
49
|
|
Overall Study
COMPLETED
|
35
|
39
|
|
Overall Study
NOT COMPLETED
|
11
|
10
|
Reasons for withdrawal
| Measure |
Levodopa/Carbidopa/Entacapone
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.
|
Levodopa/Carbidopa
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 Study
Adverse Event
|
3
|
0
|
|
Overall Study
Other
|
8
|
10
|
Baseline Characteristics
Efficacy of Levodopa/Carbidopa/Entacapone vs Levodopa/Carbidopa in Parkinson's Disease Patients With Early Wearing-off
Baseline characteristics by cohort
| Measure |
Levodopa/Carbidopa/Entacapone
n=45 Participants
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.
|
Levodopa/Carbidopa
n=49 Participants
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
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
66.40 Years
STANDARD_DEVIATION 8.18 • n=5 Participants
|
66.45 Years
STANDARD_DEVIATION 9.04 • n=7 Participants
|
66.43 Years
STANDARD_DEVIATION 8.59 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
45 participants
n=5 Participants
|
49 participants
n=7 Participants
|
94 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to end of study (Month 3)Population: Per Protocol set with the last observation carried forward (LOCF)
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.
Outcome measures
| Measure |
Levodopa/Carbidopa/Entacapone
n=35 Participants
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.
|
Levodopa/Carbidopa
n=36 Participants
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.
|
|---|---|---|
|
Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living [ADL]) Score From Baseline to Month 3
|
-2.5 Units on a scale
Standard Deviation 2.8
|
-0.5 Units on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: Baseline to end of study (Month 3)Population: Per Protocol set with LOCF
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.
Outcome measures
| Measure |
Levodopa/Carbidopa/Entacapone
n=35 Participants
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.
|
Levodopa/Carbidopa
n=36 Participants
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.
|
|---|---|---|
|
Change in the UPDRS Part I (Mentation, Behavior, and Mood) Score From Baseline to Month 3
|
-0.5 Units on a scale
Standard Deviation 1.6
|
-0.2 Units on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline to end of study (Month 3)Population: Per Protocol set with LOCF
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.
Outcome measures
| Measure |
Levodopa/Carbidopa/Entacapone
n=35 Participants
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.
|
Levodopa/Carbidopa
n=36 Participants
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.
|
|---|---|---|
|
Change in the UPDRS Part III (Motor Function) Score From Baseline to Month 3
|
-4.0 Units on a scale
Standard Deviation 4.6
|
-1.42 Units on a scale
Standard Deviation 5.5
|
SECONDARY outcome
Timeframe: Baseline to end of study (Month 3)Population: Per Protocol set with LOCF
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.
Outcome measures
| Measure |
Levodopa/Carbidopa/Entacapone
n=35 Participants
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.
|
Levodopa/Carbidopa
n=36 Participants
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.
|
|---|---|---|
|
Change in the UPDRS Part IV (Complications of Therapy) Score From Baseline to Month 3
|
-0.6 Units on a scale
Standard Deviation 1.8
|
-0.1 Units on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Baseline to end of study (Month 3)Population: Per Protocol set with LOCF
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.
Outcome measures
| Measure |
Levodopa/Carbidopa/Entacapone
n=35 Participants
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.
|
Levodopa/Carbidopa
n=36 Participants
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.
|
|---|---|---|
|
Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to Month 3
|
6.3 Units on a scale
Standard Deviation 20.4
|
0.8 Units on a scale
Standard Deviation 15.6
|
SECONDARY outcome
Timeframe: Baseline to end of study (Month 3)Population: Per Protocol set with LOCF
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.
Outcome measures
| Measure |
Levodopa/Carbidopa/Entacapone
n=34 Participants
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.
|
Levodopa/Carbidopa
n=35 Participants
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.
|
|---|---|---|
|
Patient and Investigator Global Evaluation of the Patient
Patient global evaluation
|
-0.9 Units on a scale
Standard Deviation 1.1 • Interval -2.0 to 2.0
|
-0.4 Units on a scale
Standard Deviation 1.2 • Interval -2.0 to 2.0
|
|
Patient and Investigator Global Evaluation of the Patient
Investigator global evaluation
|
-0.9 Units on a scale
Standard Deviation 1.0
|
-0.3 Units on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Baseline to end of study (Month 3)Population: Per Protocol set with LOCF
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.
Outcome measures
| Measure |
Levodopa/Carbidopa/Entacapone
n=35 Participants
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.
|
Levodopa/Carbidopa
n=36 Participants
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.
|
|---|---|---|
|
Change on the QUICK Questionnaire (QQ) Score From Baseline to Month 3
|
-0.6 Positive answers
Standard Deviation 1.8
|
-0.6 Positive answers
Standard Deviation 2.3
|
Adverse Events
Levodopa/Carbidopa/Entacapone
Levodopa/Carbidopa
Serious adverse events
| Measure |
Levodopa/Carbidopa/Entacapone
n=45 participants at risk
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.
|
Levodopa/Carbidopa
n=49 participants at risk
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.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
2.2%
1/45
|
0.00%
0/49
|
|
Psychiatric disorders
Delusion
|
0.00%
0/45
|
2.0%
1/49
|
Other adverse events
| Measure |
Levodopa/Carbidopa/Entacapone
n=45 participants at risk
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.
|
Levodopa/Carbidopa
n=49 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Retching
|
6.7%
3/45
|
4.1%
2/49
|
|
Nervous system disorders
Dyskinesia
|
15.6%
7/45
|
2.0%
1/49
|
|
Psychiatric disorders
Anxiety
|
11.1%
5/45
|
0.00%
0/49
|
Additional Information
Study Director
Novartis Pharmaceuticals
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER