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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
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/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/show/NCT00174239