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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00143026




Registration number
NCT00143026
Ethics application status
Date submitted
31/08/2005
Date registered
2/09/2005
Date last updated
29/03/2017

Titles & IDs
Public title
Study to Compare the Effect of Treatment With Carbidopa/Levodopa/Entacapone on the Quality of Life of Patients With Parkinson's Disease. This Study is Not Recruiting in the United States
Scientific title
Study to Compare the Effect of Treatment With Carbidopa/Levodopa/Entacapone on the Quality of Life of Patients With Parkinson's Disease.
Secondary ID [1] 0 0
CELC200A2406
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - carbidopa, levodopa, entacapone

Treatment: Drugs: carbidopa, levodopa, entacapone
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Quality of life assessment
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Symptom control change from baseline
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Change from baseline in number of wearing-off symptoms
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Change from baseline in proportion of patients experiencing wearing-off
Timepoint [3] 0 0

Eligibility
Key inclusion criteria
- Clinical diagnosis of idiopathic Parkinson's disease exhibiting at least 2 or 3
symptoms

- Motor functions must be regarded as non-disabling by the patient
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- History, signs or symptoms suggesting the diagnosis of atypical or secondary
parkinsonism

- History of dyskinesia

- Previous or current use of entacapone or tolcapone

- Unstable Parkinson's disease patients requiring/receiving regimens of levodopa

- Subjects taking levodopa/DDCI controlled release or extended release formulations

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2006
Sample size
Target
Accrual to date
Final
184
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Watkins Medical Center - Brisbane
Recruitment hospital [3] 0 0
Central Coast Neuroscience Research - Gosford
Recruitment hospital [4] 0 0
Heidelberg Repatriation Hospital - Melbourne
Recruitment hospital [5] 0 0
Monash Medical Centre - Melbourne
Recruitment hospital [6] 0 0
Sir Charles Gairdner Hospital - Perth
Recruitment hospital [7] 0 0
Concord Hospital - Sydney
Recruitment hospital [8] 0 0
Southern Neurology, St. George Private Hospital - Sydney
Recruitment hospital [9] 0 0
Westmead Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Gosford
Recruitment postcode(s) [4] 0 0
- Melbourne
Recruitment postcode(s) [5] 0 0
- Perth
Recruitment postcode(s) [6] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Philippines
State/province [1] 0 0
Manila
Country [2] 0 0
Taiwan
State/province [2] 0 0
Linkou
Country [3] 0 0
Thailand
State/province [3] 0 0
Bangkok
Country [4] 0 0
Thailand
State/province [4] 0 0
Bankok

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study examines the effect of treatment of levodopa/entacapone on quality of life, as
measured by the Parkinson's Disease-Questionnaire 8 (PDQ-8), in Parkinson's disease patients
with no or minimal, non-disabling motor fluctuations.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00143026
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00143026