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

A Double-Blind, Randomized, Comparative Study of Cabaser and Sinemet CR For The Treatment Of Nocturnal Disability In Levodopa -Treated Parkinson's Disease Patients.

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00174239

Enrollment

220

Registered

2005-09-15

Start date

2004-07-31

Completion date

2005-09-30

Last updated

2007-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Brief summary

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

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

DRUGcabergoline

DRUGcontrolled-release levodopa / carbidopa

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Idiopathic Parkinson Disease * Must be experiencing sleep akinesia

Exclusion criteria

* Current treatment with other dopamine agonists * Nocturnal hallucinations * Dementia

Design outcomes

Primary

Measure	Time frame
PDSS, UPDRS	—

Secondary

Measure	Time frame
CGI, PGI, Epworth Sleepiness Scale, PDQ-39	—

Countries

Australia, Italy, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026