ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy (STRIDE-PD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00099268
Recruitment Status : Completed
First Posted : December 10, 2004
Results First Posted : March 8, 2011
Last Update Posted : April 23, 2012
Sponsor:
Collaborator:
Orion Corporation, Orion Pharma
Information provided by:
Novartis

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Parkinson's Disease
Interventions: Drug: Carbidopa/levodopa/entacapone
Drug: Immediate release carbidopa/levodopa

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Carbidopa/Levodopa/Entacapone Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
Carbidopa/Levodopa Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.

Participant Flow:   Overall Study
    Carbidopa/Levodopa/Entacapone   Carbidopa/Levodopa
STARTED   374   373 
Intent-to-Treat   373 [1]   372 
COMPLETED   282 [2]   291 [3] 
NOT COMPLETED   92   82 
Withdrawal by Subject                46                28 
Adverse Event                19                19 
Protocol Violation                9                8 
Lost to Follow-up                6                4 
Lack of Efficacy                5                18 
Administrative problems                4                4 
Death                3                1 
[1] One patient from each group discontinued without receiving a single dose of study drug.
[2] Plus 1 death in the carbidopa/levodopa/entacapone group within 30 days of treatment discontinuation
[3] Plus 1 death in the carbidopa/levodopa group within 30 days of treatment discontinuation



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Carbidopa/Levodopa/Entacapone Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
Carbidopa/Levodopa Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
Total Total of all reporting groups

Baseline Measures
   Carbidopa/Levodopa/Entacapone   Carbidopa/Levodopa   Total 
Overall Participants Analyzed 
[Units: Participants]
 373   372   745 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 60.6  (8.67)   59.8  (8.20)   60.2  (8.44) 
[1] Baseline numbers represent the Intent-to-treat (ITT) population. Of the 747 randomized patients, one patient in each group discontinued the study without receiving a single dose of study drug and was excluded from the ITT population.
Gender 
[Units: Participants]
     
Female   128   150   278 
Male   245   222   467 


  Outcome Measures

1.  Primary:   Time to First Occurrence of Dyskinesia   [ Time Frame: 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 ]

2.  Secondary:   Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score (Parts II and III)   [ Time Frame: Baseline, Week 6 and Week 130 ]

3.  Secondary:   Occurrence of Wearing-off   [ Time Frame: Baseline to Week 134 ]

4.  Secondary:   Time to First Occurrence of Wearing-off   [ Time Frame: Baseline to end of study (134-208 weeks of treatment) ]

5.  Secondary:   Occurrence of Dyskinesia   [ Time Frame: Baseline to Week 208 ]

6.  Secondary:   Change From Baseline in Health-related Quality of Life Assessed Using the 39-item Parkinson's Disease Questionnaire (PDQ-39)   [ Time Frame: Baseline to Week 156 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00099268     History of Changes
Other Study ID Numbers: CELC200A2401
First Submitted: December 10, 2004
First Posted: December 10, 2004
Results First Submitted: December 15, 2010
Results First Posted: March 8, 2011
Last Update Posted: April 23, 2012