Study Of Cabaser and Sinemet CR For The Treatment Of Nighttime Symptoms Associated With Parkinson's Disease.

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00174239
• Date of registration: 09/09/2005
• Prospective Registration: No
• Primary sponsor: Pfizer
• 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.
• Date of first enrolment: July 2004
• Target sample size: 220
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00174239
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Australia, Italy, Spain, United Kingdom

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Idiopathic Parkinson Disease

- Must be experiencing sleep akinesia

Exclusion Criteria:

- Current treatment with other dopamine agonists

- Nocturnal hallucinations

- Dementia



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: cabergoline

Drug: controlled-release levodopa / carbidopa

Primary Outcome(s)

PDSS, UPDRS

Secondary Outcome(s)

CGI, PGI, Epworth Sleepiness Scale, PDQ-39

Secondary ID(s)

A7231001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors