NCT00174239

Brief Summary

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

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for phase_4 parkinson-disease

Timeline
Completed

Started Jul 2004

Shorter than P25 for phase_4 parkinson-disease

Geographic Reach
3 countries

14 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

May 25, 2007

Status Verified

May 1, 2007

First QC Date

September 9, 2005

Last Update Submit

May 24, 2007

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

  • PDSS, UPDRS

Secondary Outcomes (1)

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

Interventions

cabergolineDRUG
controlled-release levodopa / carbidopaDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Idiopathic Parkinson Disease
  • Must be experiencing sleep akinesia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Pfizer Investigational Site

Westmead, New South Wales, Australia

Location

Pfizer Investigational Site

Brisbane, Queensland, Australia

Location

Pfizer Investigational Site

Loc. Camerelle - Pozzilli, IS, Italy

Location

Pfizer Investigational Site

Vittoria, Ragusa, Italy

Location

Pfizer Investigational Site

Bologna, Italy

Location

Pfizer Investigational Site

Bolzano, Italy

Location

Pfizer Investigational Site

Napoli, Italy

Location

Pfizer Investigational Site

Padua, Italy

Location

Pfizer Investigational Site

Palermo, Italy

Location

Pfizer Investigational Site

Roma, Italy

Location

Pfizer Investigational Site

Barcelona, Barcelona, Spain

Location

Pfizer Investigational Site

Madrid, Madrid, Spain

Location

Pfizer Investigational Site

Oviedo, Principality of Asturias, Spain

Location

Pfizer Investigational Site

Seville, Sevilla, Spain

Location

Related Links

MeSH Terms

Conditions

Parkinson Disease

Interventions

CabergolineCarbidopa

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

ErgolinesErgot AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingMethyldopaDihydroxyphenylalanineCatecholaminesAminesOrganic ChemicalsHydrazinesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

July 1, 2004

Study Completion

September 1, 2005

Last Updated

May 25, 2007

Record last verified: 2007-05

Locations

AU(2)ES(4)IT(8)