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Carbidopa/Levodopa/Entacapone Versus Immediate Release (IR) Carbidopa/Levodopa on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-motor Symptoms of Wearing Off

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ClinicalTrials.gov Identifier: NCT00642356
Recruitment Status : Terminated (slow enrollment)
First Posted : March 25, 2008
Results First Posted : January 11, 2011
Last Update Posted : February 18, 2011
Sponsor:
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: Treatment
Condition Parkinson's Disease
Interventions Drug: Carbidopa/levodopa/entacapone
Drug: Immediate release carbidopa/levodopa
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Carbidopa/Levodopa/Entacapone Immediate Release Carbidopa/Levodopa
Hide Arm/Group Description Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study. Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.
Period Title: Overall Study
Started 7 7
Completed 5 4
Not Completed 2 3
Reason Not Completed
Adverse Event             1             0
Protocol Violation             0             3
Lack of Efficacy             1             0
Arm/Group Title Carbidopa/Levodopa/Entacapone Immediate Release Carbidopa/Levodopa Total
Hide Arm/Group Description Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study. Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator. Total of all reporting groups
Overall Number of Baseline Participants 7 7 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 14 participants
<=18 years 0 0 0
Between 18 and 65 years 1 0 1
>= 65 years 6 7 13
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 14 participants
Female
5
  71.4%
2
  28.6%
7
  50.0%
Male
2
  28.6%
5
  71.4%
7
  50.0%
1.Primary Outcome
Title Change From Baseline on the Non-motor Score of the Quantitative Wearing-Off Questionnaire 9 Item (QWOQ-9)
Hide Description The QWOQ-9 is a self-rated questionnaire used to assess motor and non-motor symptoms of Parkinson’s disease. The 4 non-motor symptoms are each measured on a five item (0-4) Likert scale, reflecting the severity of the item from “not present” to “very severe”. The range of possible score values of the non-motor subscale of the QWOQ-9 is 0 to 16. A higher score indicates greater disability. A negative change score indicates improvement.
Time Frame Baseline to 15 minutes prior to 2nd dose at Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects that were assessed for efficacy
Arm/Group Title Carbidopa/Levodopa/Entacapone Immediate Release Carbidopa/Levodopa
Hide Arm/Group Description:
Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study.
Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.
Overall Number of Participants Analyzed 7 5
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-0.9  (0.90) -0.2  (2.49)
2.Secondary Outcome
Title Change From Baseline on the Motor Score of the Quantitative Wearing-Off Questionnaire 9 Item (QWOQ-9)
Hide Description The QWOQ-9 is a self-rated questionnaire used to assess motor and non-motor symptoms of Parkinson’s disease. The 5 motor symptoms are each measured on a five item (0-4) Likert scale, reflecting the severity of the item from “not present” to “very severe”. The range of possible score values of the motor subscale of the QWOQ-9 is 0 to 20. A higher score indicates greater disability. A negative change score indicates improvement.
Time Frame Baseline to 15 minutes prior to 2nd dose at Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects that were assessed for efficacy
Arm/Group Title Carbidopa/Levodopa/Entacapone Immediate Release Carbidopa/Levodopa
Hide Arm/Group Description:
Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study.
Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.
Overall Number of Participants Analyzed 6 5
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-1.2  (2.23) 0.0  (2.00)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Carbidopa/Levodopa/Entacapone Immediate Release Carbidopa/Levodopa
Hide Arm/Group Description Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study. Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.
All-Cause Mortality
Carbidopa/Levodopa/Entacapone Immediate Release Carbidopa/Levodopa
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Carbidopa/Levodopa/Entacapone Immediate Release Carbidopa/Levodopa
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/7 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Carbidopa/Levodopa/Entacapone Immediate Release Carbidopa/Levodopa
Affected / at Risk (%) Affected / at Risk (%)
Total   4/7 (57.14%)   1/7 (14.29%) 
Gastrointestinal disorders     
Dyspepsia  1  1/7 (14.29%)  0/7 (0.00%) 
Nausea  1  2/7 (28.57%)  0/7 (0.00%) 
Vomiting  1  1/7 (14.29%)  0/7 (0.00%) 
General disorders     
Nervousness  1  1/7 (14.29%)  0/7 (0.00%) 
Fatigue  1  1/7 (14.29%)  0/7 (0.00%) 
Oedema  1  1/7 (14.29%)  0/7 (0.00%) 
Infections and infestations     
Urinary tract infection  1  1/7 (14.29%)  0/7 (0.00%) 
Injury, poisoning and procedural complications     
Excoriation  1  0/7 (0.00%)  1/7 (14.29%) 
Fall  1  1/7 (14.29%)  1/7 (14.29%) 
Head injury  1  0/7 (0.00%)  1/7 (14.29%) 
Investigations     
Urine colour abnormal  1  1/7 (14.29%)  0/7 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/7 (14.29%)  0/7 (0.00%) 
Muscle spasms  1  0/7 (0.00%)  1/7 (14.29%) 
Trismus  1  1/7 (14.29%)  0/7 (0.00%) 
Nervous system disorders     
Disturbance in attention  1  1/7 (14.29%)  0/7 (0.00%) 
Dizziness  1  1/7 (14.29%)  0/7 (0.00%) 
Headache  1  1/7 (14.29%)  0/7 (0.00%) 
Somnolence  1  0/7 (0.00%)  1/7 (14.29%) 
Psychiatric disorders     
Anxiety  1  1/7 (14.29%)  0/7 (0.00%) 
Renal and urinary disorders     
Pollakiuria  1  1/7 (14.29%)  1/7 (14.29%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  1/7 (14.29%)  0/7 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
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
ClinicalTrials.gov Identifier: NCT00642356     History of Changes
Other Study ID Numbers: CELC200AUS14
First Submitted: March 19, 2008
First Posted: March 25, 2008
Results First Submitted: December 14, 2010
Results First Posted: January 11, 2011
Last Update Posted: February 18, 2011