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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/NCT00174239




Registration number
NCT00174239
Ethics application status
Date submitted
9/09/2005
Date registered
15/09/2005
Date last updated
25/05/2007

Titles & IDs
Public title
Study Of Cabaser and Sinemet CR For The Treatment Of Nighttime Symptoms Associated With Parkinson's Disease.
Scientific title
A Double-Blind, Randomized, Comparative Study of Cabaser and Sinemet CR For The Treatment Of Nocturnal Disability In Levodopa -Treated Parkinson's Disease Patients.
Secondary ID [1] 0 0
A7231001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson 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 - cabergoline
Treatment: Drugs - controlled-release levodopa / carbidopa

Treatment: Drugs: cabergoline


Treatment: Drugs: controlled-release levodopa / carbidopa
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
PDSS, UPDRS
Timepoint [1] 0 0
Secondary outcome [1] 0 0
CGI, PGI, Epworth Sleepiness Scale, PDQ-39
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- Idiopathic Parkinson Disease

- Must be experiencing sleep akinesia
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Current treatment with other dopamine agonists

- Nocturnal hallucinations

- Dementia

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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2005
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Westmead
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Brisbane
Recruitment postcode(s) [1] 0 0
- Westmead
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment outside Australia
Country [1] 0 0
Italy
State/province [1] 0 0
IS
Country [2] 0 0
Italy
State/province [2] 0 0
Ragusa
Country [3] 0 0
Italy
State/province [3] 0 0
Bologna
Country [4] 0 0
Italy
State/province [4] 0 0
Bolzano
Country [5] 0 0
Italy
State/province [5] 0 0
Napoli
Country [6] 0 0
Italy
State/province [6] 0 0
Padova
Country [7] 0 0
Italy
State/province [7] 0 0
Palermo
Country [8] 0 0
Italy
State/province [8] 0 0
Roma
Country [9] 0 0
Spain
State/province [9] 0 0
Asturias
Country [10] 0 0
Spain
State/province [10] 0 0
Barcelona
Country [11] 0 0
Spain
State/province [11] 0 0
Madrid
Country [12] 0 0
Spain
State/province [12] 0 0
Sevilla

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

Ethics approval
Ethics application status

Summary
Brief summary
The study will assess the relative benefit of cabergoline vs carbidopa/levodopa therapy in
treating nighttime problems of Parkinson Disease.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00174239
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
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/NCT00174239