Study to Evaluate Initiation of Stalevo in Early Wearing-off

Parkinson's Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00462007
• Other study ID #: 2939117
• Status: Completed
• Phase: Phase 4
• First received: April 17, 2007
• Last updated: April 20, 2015
• Start date: September 2006
• Est. completion date: December 2007

Study information

• Verified date: April 2015
• Source: Orion Corporation, Orion Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyGermany: Federal Institute for Drugs and Medical DevicesDenmark: Danish Medicines AgencySweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Description:

See 'Brief summary'.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: December 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Stalevo
Oral 3-4 daily doses for 6 weeks

Locations

Country	Name	City	State
Germany	Humboldt Universität Charité Neurologische Klinik	Berlin
Germany	St. Josef-Hospital, Klinikum der Ruhr-Universität-Bochum Neurologische Klinik	Bochum
Germany	Pharmakologisches Studienzentrum Chemnitz	Chemnitz
Germany	Universitätsklinikum Carl Gustav Carus Klinik und Poliklinik für Neurologie	Dresden
Germany	Gemeinschaftspraxis für Neurologie & Psychiatrie	Erbach
Germany	Neurologische Praxis Dr Christine Schuster	Giessen
Germany	Universitätskrankenhaus Eppendorf	Hamburg
Germany	Paracelsus-Elena Klinik	Kassel
Germany	Nervenarztpraxis Dr Alexander Nass	Köln
Germany	Alexianer-Krankenhaus	Krefeld
Germany	Universitätsklinikum Gießen und Marburg GmbH	Marburg
Germany	Asklepios Fachklinikum Stadtroda	Stadtroda
Germany	Eberhard-Karls-Universität, Universitätsklinikum Tübingen, Zentrum für Neurologie	Tübingen
Germany	Neurologische Klinik der Universität Ulm	Ulm
Sweden	Länsjukhuset Ryhov, Geriatriska Kliniken	Jönköping
Sweden	Nyköpings Lasarett, Ger/Rehabkliniken	Nyköping
Sweden	Visby lasarett, Neurologmottagningen	Visby
United Kingdom	The Royal Bournemouth Hospital, Department of Medicines for the Elderly	Bournemouth	Dorset
United Kingdom	Royal Sussex County Hospital, Neurology Department	Brighton
United Kingdom	North Tyneside General Hospital, Department of Medicine	North Shields	Tyne and Wear

Sponsors (1)

Lead Sponsor	Collaborator
Orion Corporation, Orion Pharma

Countries where clinical trial is conducted

Germany,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Global Impression of Change (Patient)		6 weeks	No
Secondary	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	No