NCT00125567

Brief Summary

The purpose of this study is to demonstrate in patients with Parkinson's disease that, when compared to levodopa/carbidopa, Stalevo will delay the time from initiation of study drug to the time an increase in antiparkinsonian medication is required due to inadequately controlled parkinsonian symptoms.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
223

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2005

Longer than P75 for phase_4

Geographic Reach
6 countries

19 active sites

Status
completed

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

First Submitted

Initial submission to the registry

July 29, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2005

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2005

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

June 22, 2009

Status Verified

June 1, 2009

Enrollment Period

3.6 years

First QC Date

July 29, 2005

Last Update Submit

June 19, 2009

Conditions

Idiopathic Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • The time until a patient requires changes in antiparkinsonian therapy due to inadequately controlled parkinsonian symptoms

    Up to 2 years of treatment

Secondary Outcomes (4)

  • Unified Parkinson's Disease Rating Scale

    Up to 2 years of treatment

  • Clinical Global Impression of Change (investigator)

    Up to 2 years of treatment

  • Parkinson's Disease Questionnaire (PDQ-39)

    Up to 2 years of treatment

  • Work Impairment Questionnaire

    Up to 2 years of treatment

Study Arms (2)

1

EXPERIMENTAL

Stalevo (levodopa/carbidopa/entacapone)

Drug: Stalevo (levodopa/carbidopa/entacapone)

2

ACTIVE COMPARATOR

Levodopa/carbidopa

Drug: Levodopa/carbidopa

Interventions

Stalevo (levodopa/carbidopa/entacapone)DRUG

Oral, 50-150 mg levodopa four times daily, for up to 2 years

1
Levodopa/carbidopaDRUG

Oral capsules, 50-150 mg levodopa four times daily, for up to 2 years

2

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Idiopathic Parkinson's disease
  • Treatment with 3 equal daily doses of levodopa/carbidopa up to 450 mg/day
  • Unchanged antiparkinsonian medication for 6 weeks prior to baseline

You may not qualify if:

  • Secondary or atypical parkinsonism
  • Patients with daily unpredictable OFF periods or painful dyskinesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Aalborg Hospital

Aalborg, DK-9000 Aalborg, Denmark

Location

Bispebjerg Hospital

Copenhagen, Denmark

Location

Århus Kommunehospital

Nørrebrogade 44, 8000, Denmark

Location

South Karelia Central Hospital

Lappeenranta, Finland

Location

Tampere University Hospital

Tampere, 33521 Tampere, Finland

Location

Parkinson Klinik Bad Nauheim

Bad Nauheim, 61231 Bad Nauheim, Germany

Location

Neurologische Klinik Bad Neustadt

Bad Neustadt an der Saale, 97616 Bad Neustadt, Germany

Location

Neurologische Klinik der Universitat Dusseldorf

Düsseldorf, 40225 Duesseldorf, Germany

Location

Allgemeines Krankenhaus Harburg

Hamburg, 21075 Hamburg, Germany

Location

Praxis Drs Lang, Krauss, Schreiber

Ulm, 89073 Ulm, Germany

Location

Mater Private Hospital

Dublin, Dublin 7, Ireland

Location

Universitetssjukhuset MAS

Malmo, SE-205 02, Sweden

Location

Läkarhuset Vällingby

Vällingby, SE-162 68, Sweden

Location

Movement Disorder Services

Chertsey, Surrey, KT16 0QA, United Kingdom

Location

University Hospital of Wales

Cardiff, Wales, CF14 4XW, United Kingdom

Location

Glan Clwyd Hospital

Rhyl, Wales, CF14 4XW, United Kingdom

Location

Frenchay Hospital

Bristol, BS16 1LE, United Kingdom

Location

Leigh Infirmary

Leigh, WN7 1HS, United Kingdom

Location

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

StalevoLevodopacarbidopa, levodopa drug combination

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

DihydroxyphenylalanineCatecholaminesAminesOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsTyrosine

Study Officials

  • Andrew Wighton, BSc (Hons)

    Orion Corporation, Orion Pharma

    STUDY DIRECTOR

  • Bhadravati SD Sastry, FRCP

    University Hospital of Wales and Rookwood Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 29, 2005

First Posted

August 1, 2005

Study Start

August 1, 2005

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

June 22, 2009

Record last verified: 2009-06

Locations

GB(6)FI(2)DE(5)IE(1)SE(2)DK(3)