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

Overview

The study will assess the relative benefit of cabergoline vs carbidopa/levodopa therapy in treating nighttime problems of Parkinson Disease.

Full Title of Study: “A Double-Blind, Randomized, Comparative Study of Cabaser and Sinemet CR For The Treatment Of Nocturnal Disability In Levodopa -Treated Parkinson’s Disease Patients.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double

Detailed Description

The trial was terminated prematurely June 26, 2005 due to the inability to re-supply study drug for the planned number of subjects. There were no safety or efficacy concerns regarding the study in the decision to terminate the trial.

Interventions

  • Drug: cabergoline
  • Drug: controlled-release levodopa / carbidopa

Clinical Trial Outcome Measures

Primary Measures

  • PDSS, UPDRS

Secondary Measures

  • CGI, PGI, Epworth Sleepiness Scale, PDQ-39

Participating in This Clinical Trial

Inclusion Criteria

  • Idiopathic Parkinson Disease – Must be experiencing sleep akinesia Exclusion Criteria:

  • Current treatment with other dopamine agonists – Nocturnal hallucinations – Dementia

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pfizer
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

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