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Study to Evaluate Initiation of Stalevo in Early Wearing-off (SENSE)

Primary Purpose

Parkinson's Disease

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Stalevo

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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)

Exclusion Criteria:

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.

Sites / Locations

Humboldt Universität Charité Neurologische Klinik
St. Josef-Hospital, Klinikum der Ruhr-Universität-Bochum Neurologische Klinik
Pharmakologisches Studienzentrum Chemnitz
Universitätsklinikum Carl Gustav Carus Klinik und Poliklinik für Neurologie
Gemeinschaftspraxis für Neurologie & Psychiatrie
Neurologische Praxis Dr Christine Schuster
Universitätskrankenhaus Eppendorf
Paracelsus-Elena Klinik
Alexianer-Krankenhaus
Nervenarztpraxis Dr Alexander Nass
Universitätsklinikum Gießen und Marburg GmbH
Asklepios Fachklinikum Stadtroda
Eberhard-Karls-Universität, Universitätsklinikum Tübingen, Zentrum für Neurologie
Neurologische Klinik der Universität Ulm
Länsjukhuset Ryhov, Geriatriska Kliniken
Nyköpings Lasarett, Ger/Rehabkliniken
Visby lasarett, Neurologmottagningen
The Royal Bournemouth Hospital, Department of Medicines for the Elderly
North Tyneside General Hospital, Department of Medicine
Royal Sussex County Hospital, Neurology Department

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Stalevo

Outcomes

Primary Outcome Measures

Clinical Global Impression of Change (Patient)

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00462007

First Posted

April 17, 2007

Last Updated

April 20, 2015

Sponsor

Orion Corporation, Orion Pharma

1. Study Identification

Unique Protocol Identification Number

NCT00462007

Brief Title

Study to Evaluate Initiation of Stalevo in Early Wearing-off

Acronym

SENSE

Official Title

Efficacy and Safety of Stalevo® in Subjects With Early Wearing-off Identified Using a Screening Tool WOQ-9; an Open, Non-randomised, Multinational, Multicentre 6-week Direct Switch Study in Levodopa-treated Parkinson's Disease Patients

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

September 2006 (undefined)

Primary Completion Date

August 2007 (Actual)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Orion Corporation, Orion Pharma

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

See 'Brief summary'.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson's Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

115 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Stalevo

Intervention Type

Drug

Intervention Name(s)

Stalevo

Intervention Description

Oral 3-4 daily doses for 6 weeks

Primary Outcome Measure Information:

Title

Clinical Global Impression of Change (Patient)

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wolfgang H. Oertel, Professor

Organizational Affiliation

Universitätsklinikum Giessen und Marburg GmbH

Official's Role

Principal Investigator

Facility Information:

Facility Name

Humboldt Universität Charité Neurologische Klinik

City

Berlin

ZIP/Postal Code

10098

Country

Germany

Facility Name

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

City

Bochum

ZIP/Postal Code

44791

Country

Germany

Facility Name

Pharmakologisches Studienzentrum Chemnitz

City

Chemnitz

ZIP/Postal Code

09111

Country

Germany

Facility Name

Universitätsklinikum Carl Gustav Carus Klinik und Poliklinik für Neurologie

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Gemeinschaftspraxis für Neurologie & Psychiatrie

City

Erbach

ZIP/Postal Code

64711

Country

Germany

Facility Name

Neurologische Praxis Dr Christine Schuster

City

Giessen

ZIP/Postal Code

35390

Country

Germany

Facility Name

Universitätskrankenhaus Eppendorf

City

Hamburg

ZIP/Postal Code

20251

Country

Germany

Facility Name

Paracelsus-Elena Klinik

City

Kassel

ZIP/Postal Code

34128

Country

Germany

Facility Name

Alexianer-Krankenhaus

City

Krefeld

ZIP/Postal Code

47805

Country

Germany

Facility Name

Nervenarztpraxis Dr Alexander Nass

City

Köln

ZIP/Postal Code

51069

Country

Germany

Facility Name

Universitätsklinikum Gießen und Marburg GmbH

City

Marburg

ZIP/Postal Code

D-35039

Country

Germany

Facility Name

Asklepios Fachklinikum Stadtroda

City

Stadtroda

ZIP/Postal Code

07646

Country

Germany

Facility Name

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

City

Tübingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Neurologische Klinik der Universität Ulm

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

Länsjukhuset Ryhov, Geriatriska Kliniken

City

Jönköping

ZIP/Postal Code

55185

Country

Sweden

Facility Name

Nyköpings Lasarett, Ger/Rehabkliniken

City

Nyköping

ZIP/Postal Code

61185

Country

Sweden

Facility Name

Visby lasarett, Neurologmottagningen

City

Visby

ZIP/Postal Code

62184

Country

Sweden

Facility Name

The Royal Bournemouth Hospital, Department of Medicines for the Elderly

City

Bournemouth

State/Province

Dorset

ZIP/Postal Code

BH7 7DW

Country

United Kingdom

Facility Name

North Tyneside General Hospital, Department of Medicine

City

North Shields

State/Province

Tyne and Wear

ZIP/Postal Code

NE29 8NH

Country

United Kingdom

Facility Name

Royal Sussex County Hospital, Neurology Department

City

Brighton

ZIP/Postal Code

BN2 5BE

Country

United Kingdom

12. IPD Sharing Statement

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Study to Evaluate Initiation of Stalevo in Early Wearing-off

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