Trial · NCT00099268
Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy
NCT00099268, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2011-03-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy. Trials, record NCT00099268. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00099268
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy
- NCT number
- NCT00099268
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 747 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Parkinson's Disease
- Interventions
- Carbidopa/levodopa/entacapone, Immediate release carbidopa/levodopa
- First posted
- 2004-12-10
- Last updated
- 2012-04-23
- Results first posted
- 2011-03-08
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to First Occurrence of Dyskinesia | Treatment duration for an individual patient varied between a minimum of 134 weeks for those patients recruited last and a maximum of 208 weeks for those patients recruited first | Dyskinesia was assessed by a blinded rater at each visit. Time to dyskinesia was defined as the visit at which the rater first answered "yes" to the following question: "In your opinion, does this patient have dyskinesia?" Time to dyskinesia was estimated by Kaplan-Meier product limit estimate that takes into consideration patients who did not experience dyskinesia by censoring them at the end of the study. |
| Secondary | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score (Parts II and III) | Baseline, Week 6 and Week 130 | The UPDRS is a standardized assessment scale used to measure the patient's disease state. It was to be completed by a blinded rater. There are 6 parts to the UPDRS. Part II (items 5-17; total score 0-52 units on the scale) measures the patient's activities of daily living and part III (items 18-31; total score 0-56 units on the scale) measures the motor function of the patient. The total score ranges from 0 to 108 units on the scale. A higher score indicates greater disability. A negative change score indicates improvement. |
| Secondary | Occurrence of Wearing-off | Baseline to Week 134 | Wearing-off is defined as a perception of loss of mobility or dexterity, usually taking place gradually over minutes (up to an hour) and usually bearing a close temporal relationship to the timing of anti-parkinsonian medications; it does not include early-morning akinesia. To ascertain its occurrence, a blinded rater questioned the patient as to whether he/she had noticed that the benefits of the study drug were wearing-off. |
| Secondary | Time to First Occurrence of Wearing-off | Baseline to end of study (134-208 weeks of treatment) | Wearing off is defined as a perception of loss of mobility or dexterity, usually taking place gradually over minutes (up to an hour) and usually bearing a close temporal relationship to the timing of anti-parkinsonian medications; it does not include early-morning akinesia. To ascertain its occurrence, a blinded rater questioned the patient whether he/she had noticed that the benefits of the study drug wear-off. A motor complications and patient questionnaire card were provided to assist the blinded rater in determining whether a patient had experienced wearing-off. |
| Secondary | Occurrence of Dyskinesia | Baseline to Week 208 | Dyskinesia was assessed by a blinded rater at each visit. Time to dyskinesia was defined as the visit at which the rater first answered "yes" to the following question: "In your opinion, does this patient have dyskinesia?" |
| Secondary | Change From Baseline in Health-related Quality of Life Assessed Using the 39-item Parkinson's Disease Questionnaire (PDQ-39) | Baseline to Week 156 | The PDQ-39 instrument is 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, cognition, 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 190. A lower score indicates better quality of life. A negative change score indicates an improvement. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to First Occurrence of Dyskinesia | Treatment duration for an individual patient varied between a minimum of 134 weeks for those patients recruited last and a maximum of 208 weeks for those patients recruited first | The intent to treat (ITT) population consisted of all patients randomized who received at least one dose of study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned at randomization. | weeks | NUMBER |
| SECONDARY | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score (Parts II and III) | Baseline, Week 6 and Week 130 | The intent to treat (ITT) population consisted of all patients randomized who received at least one dose of study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned at randomization. | Units on a scale | MEAN |
| SECONDARY | Occurrence of Wearing-off | Baseline to Week 134 | The intent to treat (ITT) population consisted of all patients randomized who received at least one dose of study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned at randomization. Subjects who discontinued treatment before 134 weeks without wearing-off were excluded. | Participants | NUMBER |
| SECONDARY | Time to First Occurrence of Wearing-off | Baseline to end of study (134-208 weeks of treatment) | The intent to treat (ITT) population consisted of all patients randomized who received at least one dose of study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned at randomization. | Weeks | MEAN |
| SECONDARY | Occurrence of Dyskinesia | Baseline to Week 208 | The intent to treat (ITT) population consisted of all patients randomized who received at least one dose of study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned at randomization. Subjects who discontinued from treatment before 134 weeks without dyskinesia were excluded. | Participants | NUMBER |
| SECONDARY | Change From Baseline in Health-related Quality of Life Assessed Using the 39-item Parkinson's Disease Questionnaire (PDQ-39) | Baseline to Week 156 | The intent to treat (ITT) population consisted of all patients randomized who received at least one dose of study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned at randomization. | Units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to First Occurrence of Dyskinesia | Carbidopa/Levodopa/Entacapone | 90.7 | 95% Confidence Interval 47.9 | weeks | |
| Time to First Occurrence of Dyskinesia | Carbidopa/Levodopa | 117.1 | 95% Confidence Interval 51.5 | weeks | |
| Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score (Parts II and III) | Carbidopa/Levodopa/Entacapone | Change from baseline to Week 6 | 21.9 | Standard Deviation 11.96 | Units on a scale |
| Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score (Parts II and III) | Carbidopa/Levodopa | Change from baseline to Week 6 | 21.8 | Standard Deviation 11.24 | Units on a scale |
| Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score (Parts II and III) | Carbidopa/Levodopa/Entacapone | Change from baseline to Week 130 | 23.2 | Standard Deviation 13.38 | Units on a scale |
| Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score (Parts II and III) | Carbidopa/Levodopa | Change from baseline to Week 130 | 22.8 | Standard Deviation 13.21 | Units on a scale |
| Occurrence of Wearing-off | Carbidopa/Levodopa/Entacapone | 139 | 45.6 | Participants | |
| Occurrence of Wearing-off | Carbidopa/Levodopa | 161 | 48.3 | Participants | |
| Time to First Occurrence of Wearing-off | Carbidopa/Levodopa/Entacapone | 131.7 | Standard Error 3.8 | Weeks | |
| Time to First Occurrence of Wearing-off | Carbidopa/Levodopa | 129.5 | Standard Error 3.6 | Weeks |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Carbidopa/Levodopa/Entacapone | 374 | |
| Overall Study | STARTED | Carbidopa/Levodopa | 373 | |
| Overall Study | Intent-to-Treat | Carbidopa/Levodopa/Entacapone | 373 | |
| Overall Study | Intent-to-Treat | Carbidopa/Levodopa | 372 | |
| Overall Study | COMPLETED | Carbidopa/Levodopa/Entacapone | 282 | |
| Overall Study | COMPLETED | Carbidopa/Levodopa | 291 | |
| Overall Study | NOT COMPLETED | Carbidopa/Levodopa/Entacapone | 92 | |
| Overall Study | NOT COMPLETED | Carbidopa/Levodopa | 82 |
Source ClinicalTrials.gov
Adverse events450
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | Carbidopa/Levodopa/Entacapone | 50 | 373 | |
| other | Constipation | Gastrointestinal disorders | Carbidopa/Levodopa | 44 | 371 | |
| other | Diarrhoea | Gastrointestinal disorders | Carbidopa/Levodopa/Entacapone | 65 | 373 | |
| other | Diarrhoea | Gastrointestinal disorders | Carbidopa/Levodopa | 28 | 371 | |
| other | Dry mouth | Gastrointestinal disorders | Carbidopa/Levodopa/Entacapone | 19 | 373 | |
| other | Dry mouth | Gastrointestinal disorders | Carbidopa/Levodopa | 13 | 371 | |
| other | Dyspepsia | Gastrointestinal disorders | Carbidopa/Levodopa/Entacapone | 14 | 373 | |
| other | Dyspepsia | Gastrointestinal disorders | Carbidopa/Levodopa | 20 | 371 | |
| other | Nausea | Gastrointestinal disorders | Carbidopa/Levodopa/Entacapone | 114 | 373 | |
| other | Nausea | Gastrointestinal disorders | Carbidopa/Levodopa | 70 | 371 |
1 to 10 of 450Source ClinicalTrials.gov
See all 450 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Carbidopa/Levodopa/Entacapone | ||
| Total, all-cause mortality | Carbidopa/Levodopa | ||
| Total, other adverse events | Carbidopa/Levodopa/Entacapone | 310 | 373 |
| Total, other adverse events | Carbidopa/Levodopa | 291 | 371 |
| Total, serious adverse events | Carbidopa/Levodopa/Entacapone | 91 | 373 |
| Total, serious adverse events | Carbidopa/Levodopa | 84 | 371 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20582993 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Carbidopa/Levodopa/Entacapone vs Carbidopa/Levodopa: Occurrence of Dyskinesia | Trial comparisons |
| Carbidopa/Levodopa/Entacapone vs Carbidopa/Levodopa: Occurrence of Wearing-off | Trial comparisons |
| Carbidopa/Levodopa/Entacapone vs Carbidopa/Levodopa: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00099268
GET https://conductscience.org/api/trials/v1/NCT00099268/events?page=2