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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00391898
First received: October 24, 2006
Last updated: February 16, 2011
Last verified: February 2011
Results First Received: January 4, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Parkinson's Disease
Interventions: Drug: Levodopa/carbidopa/entacapone
Drug: Levodopa/carbidopa

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Levodopa/Carbidopa/Entacapone     Levodopa/Carbidopa  
STARTED     46 [1]   49  
COMPLETED     35     39  
NOT COMPLETED     11     10  
Adverse Event                 3                 0  
Other                 8                 10  
[1] Safety population for Levodopa/carbidopa/entacapone is 45, for Levodopa/carbidopa, per randomized.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
    Levodopa/Carbidopa/Entacapone     Levodopa/Carbidopa     Total  
Number of Participants  
[units: participants]
  45     49     94  
Age  
[units: Years]
Mean ± Standard Deviation
  66.40  ± 8.18     66.45  ± 9.04     66.43  ± 8.59  
Gender [1]
[units: participants]
     
Female     25     22     47  
Male     20     27     47  
Region of Enrollment [2]
[units: participants]
     
Spain     45     49     94  
[1] Baseline Measure based on Safety population
[2] Baseline measure based on safety population.



  Outcome Measures
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1.  Primary:   Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living [ADL]) Score From Baseline to Month 3   [ Time Frame: Baseline to end of study (Month 3) ]

2.  Secondary:   Change in the UPDRS Part I (Mentation, Behavior, and Mood) Score From Baseline to Month 3   [ Time Frame: Baseline to end of study (Month 3) ]

3.  Secondary:   Change in the UPDRS Part III (Motor Function) Score From Baseline to Month 3   [ Time Frame: Baseline to end of study (Month 3) ]

4.  Secondary:   Change in the UPDRS Part IV (Complications of Therapy) Score From Baseline to Month 3   [ Time Frame: Baseline to end of study (Month 3) ]

5.  Secondary:   Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to Month 3   [ Time Frame: Baseline to end of study (Month 3) ]

6.  Secondary:   Patient and Investigator Global Evaluation of the Patient   [ Time Frame: Baseline to end of study (Month 3) ]

7.  Secondary:   Change on the QUICK Questionnaire (QQ) Score From Baseline to Month 3   [ Time Frame: Baseline to end of study (Month 3) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862 778-8300


No publications provided


Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00391898     History of Changes
Other Study ID Numbers: CELC200AES03
Study First Received: October 24, 2006
Results First Received: January 4, 2011
Last Updated: February 16, 2011
Health Authority: Spain: Agencia Española del Medicamento y Productos Sanitarios. Ministerio de Sanidad y Consumo