Clinical Trials Logo
  1. Home
  2. Parkinson Disease
  3. NCT00174239
  4. Details
NCT00174239 Clinical Trial

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

Parkinson Disease Clinical Trial

Official 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.

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00174239
Other study ID # A7231001
Secondary ID
Status Terminated
Phase Phase 4
First received September 9, 2005
Last updated May 24, 2007
Start date July 2004
Est. completion date September 2005

Study information
Verified date May 2007
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Terminated
Enrollment 220
Est. completion date September 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Idiopathic Parkinson Disease

- Must be experiencing sleep akinesia

Exclusion Criteria:

- Current treatment with other dopamine agonists

- Nocturnal hallucinations

- Dementia

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• cabergoline

• controlled-release levodopa / carbidopa

Locations
Country Name City State
Australia Pfizer Investigational Site Brisbane Queensland
Australia Pfizer Investigational Site Westmead New South Wales
Italy Pfizer Investigational Site Bologna
Italy Pfizer Investigational Site Bolzano
Italy Pfizer Investigational Site Loc. Camerelle - Pozzilli IS
Italy Pfizer Investigational Site Napoli
Italy Pfizer Investigational Site Padova
Italy Pfizer Investigational Site Palermo
Italy Pfizer Investigational Site Roma
Italy Pfizer Investigational Site Vittoria Ragusa
Spain Pfizer Investigational Site Barcelona
Spain Pfizer Investigational Site Madrid
Spain Pfizer Investigational Site Oviedo Asturias
Spain Pfizer Investigational Site Sevilla

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

Australia,  Italy,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary PDSS, UPDRS
Secondary CGI, PGI, Epworth Sleepiness Scale, PDQ-39
See also
  Status Clinical Trial Phase
Completed NCT05415774 - Combined Deep Brain Stimulation in Parkinson's Disease N/A
Recruiting NCT04691661 - Safety, Tolerability, Pharmacokinetics and Efficacy Study of Radotinib in Parkinson's Disease Phase 2
Active, not recruiting NCT05754086 - A Multidimensional Study on Articulation Deficits in Parkinsons Disease
Completed NCT04045925 - Feasibility Study of the Taïso Practice in Parkinson's Disease N/A
Recruiting NCT04194762 - PARK-FIT. Treadmill vs Cycling in Parkinson´s Disease. Definition of the Most Effective Model in Gait Reeducation N/A
Completed NCT02705755 - TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH) Phase 2
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Recruiting NCT05830253 - Free-living Monitoring of Parkinson's Disease Using Smart Objects
Recruiting NCT03272230 - Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System N/A
Recruiting NCT06139965 - Validity and Reliability of the Turkish Version of the Comprehensive Coordination Scale in Parkinson's Patients
Completed NCT04580849 - Telerehabilitation Using a Dance Intervention in People With Parkinson's Disease N/A
Completed NCT03980418 - Evaluation of a Semiconductor Camera for the DaTSCAN™ Exam N/A
Completed NCT04477161 - Effect of Ketone Esters in Parkinson's Disease N/A
Completed NCT04942392 - Digital Dance for People With Parkinson's Disease During the COVID-19 Pandemic N/A
Terminated NCT03446833 - LFP Beta aDBS Feasibility Study N/A
Completed NCT03497884 - Individualized Precise Localization of rTMS on Primary Motor Area N/A
Completed NCT05538455 - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases N/A
Recruiting NCT04997642 - Parkinson's Disease and Movement Disorders Clinical Database
Completed NCT04117737 - A Pilot Study of Virtual Reality and Antigravity Treadmill for Gait Improvement in Parkinson N/A
Recruiting NCT03618901 - Rock Steady Boxing vs. Sensory Attention Focused Exercise N/A

External Links