NCT00462007

Brief Summary

An open, non-randomised, multinational, multicentre direct switch study in levodopa-treated Parkinson's disease patients suffering from early wearing-off in Parkinson's disease. The study will consist of 2 consecutive periods: screening period and study treatment period. Duration of the study will be up to 8 weeks for each subject. The study treatment dosage will be determined by the subject's current, separately administered standard levodopa/DDCI treatment (3-4 doses per day, maximum of total daily dose of 600 mg levodopa) which will be switched to an equivalent dose of Stalevo® without changing the number of doses per day. The levodopa daily dose during Stalevo® treatment may be adjusted according to the study subject's clinical response.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
115

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2006

Geographic Reach
3 countries

20 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

Study Start

First participant enrolled

September 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 18, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

April 21, 2015

Status Verified

April 1, 2015

Enrollment Period

11 months

First QC Date

April 17, 2007

Last Update Submit

April 20, 2015

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • Clinical Global Impression of Change (Patient)

    6 weeks

Secondary Outcomes (1)

  • Clinical Global Impression of Change (Investigator); United Parkinson's Disease Rating Scale (II, III); Quality of Life Visual Analogue Scale; Wearing-off Questionnaire with 9 symptoms

    6 weeks

Study Arms (1)

1

EXPERIMENTAL

Stalevo

Drug: Stalevo

Interventions

StalevoDRUG

Oral 3-4 daily doses for 6 weeks

1

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with idiopathic Parkinson's disease and early wearing-off symptoms treated with standard levodopa/DDCI treatment
  • Age \>35 - years
  • Hoehn and Yahr stage 1-3 performed during the 'ON'-stage
  • At least 1 symptom identified by WOQ-9
  • Dosing frequency of 3-4 doses of standard-release levodopa/DDCI (maximum total daily dose of 600 mg of levodopa)

You may not qualify if:

  • Atypical or symptomatic Parkinson's disease
  • Unpredictable OFF-periods
  • Any peak-dose dyskinesia. 'OFF'-state dystonia is allowed
  • Use of any rescue medications to treat symptoms of 'OFF'-state. 1 dose of soluble levodopa/DDCI is allowed.
  • Concomitant treatment with non-selective monoamine oxidase (MAO) inhibitor or simultaneous use of higher than recommended doses of MAO-A and MAO-B inhibitors (selegiline 10 mg or rasagiline 1 mg allowed) or use of apomorphine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Humboldt Universität Charité Neurologische Klinik

Berlin, 10098, Germany

Location

St. Josef-Hospital, Klinikum der Ruhr-Universität-Bochum Neurologische Klinik

Bochum, 44791, Germany

Location

Pharmakologisches Studienzentrum Chemnitz

Chemnitz, 09111, Germany

Location

Nervenarztpraxis Dr Alexander Nass

Cologne, 51069, Germany

Location

Universitätsklinikum Carl Gustav Carus Klinik und Poliklinik für Neurologie

Dresden, 01307, Germany

Location

Gemeinschaftspraxis für Neurologie & Psychiatrie

Erbach im Odenwald, 64711, Germany

Location

Neurologische Praxis Dr Christine Schuster

Giessen, 35390, Germany

Location

Universitätskrankenhaus Eppendorf

Hamburg, 20251, Germany

Location

Paracelsus-Elena Klinik

Kassel, 34128, Germany

Location

Alexianer-Krankenhaus

Krefeld, 47805, Germany

Location

Universitätsklinikum Gießen und Marburg GmbH

Marburg, D-35039, Germany

Location

Asklepios Fachklinikum Stadtroda

Stadtroda, 07646, Germany

Location

Eberhard-Karls-Universität, Universitätsklinikum Tübingen, Zentrum für Neurologie

Tübingen, 72076, Germany

Location

Neurologische Klinik der Universität Ulm

Ulm, 89081, Germany

Location

Länsjukhuset Ryhov, Geriatriska Kliniken

Jönköping, 55185, Sweden

Location

Nyköpings Lasarett, Ger/Rehabkliniken

Nyköping, 61185, Sweden

Location

Visby lasarett, Neurologmottagningen

Visby, 62184, Sweden

Location

The Royal Bournemouth Hospital, Department of Medicines for the Elderly

Bournemouth, Dorset, BH7 7DW, United Kingdom

Location

North Tyneside General Hospital, Department of Medicine

North Shields, Tyne and Wear, NE29 8NH, United Kingdom

Location

Royal Sussex County Hospital, Neurology Department

Brighton, BN2 5BE, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Stalevo

Condition Hierarchy (Ancestors)

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

Study Officials

  • Wolfgang H. Oertel, Professor

    Universitätsklinikum Giessen und Marburg GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 17, 2007

First Posted

April 18, 2007

Study Start

September 1, 2006

Primary Completion

August 1, 2007

Study Completion

December 1, 2007

Last Updated

April 21, 2015

Record last verified: 2015-04

Locations

SE(3)GB(3)DE(14)