Study to Evaluate Initiation of Stalevo in Early Wearing-Off - Full Text View

Sponsor:	Orion Corporation, Orion Pharma
Information provided by:	Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:	NCT00462007

Purpose

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.

Condition	Intervention	Phase
Parkinson's Disease	Drug: Stalevo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

U.S. FDA Resources

Further study details as provided by Orion Corporation, Orion Pharma:

Primary Outcome Measures:

Clinical Global Impression of Change (Patient) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

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 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment:	115
Study Start Date:	September 2006
Study Completion Date:	December 2007
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Stalevo	Drug: Stalevo Oral 3-4 daily doses for 6 weeks

Detailed Description:

See 'Brief summary'.

Eligibility

Ages Eligible for Study:	35 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00462007

Locations

Germany
Universitätsklinikum Gießen und Marburg GmbH
Marburg, Germany, D-35039
Universitätsklinikum Carl Gustav Carus Klinik und Poliklinik für Neurologie
Dresden, Germany, 01307
Eberhard-Karls-Universität, Universitätsklinikum Tübingen, Zentrum für Neurologie
Tübingen, Germany, 72076
Humboldt Universität Charité Neurologische Klinik
Berlin, Germany, 10098
St. Josef-Hospital, Klinikum der Ruhr-Universität-Bochum Neurologische Klinik
Bochum, Germany, 44791
Neurologische Klinik der Universität Ulm
Ulm, Germany, 89081
Nervenarztpraxis Dr Alexander Nass
Köln, Germany, 51069
Neurologische Praxis Dr Christine Schuster
Giessen, Germany, 35390
Gemeinschaftspraxis für Neurologie & Psychiatrie
Erbach, Germany, 64711
Alexianer-Krankenhaus
Krefeld, Germany, 47805
Pharmakologisches Studienzentrum Chemnitz
Chemnitz, Germany, 09111
Asklepios Fachklinikum Stadtroda
Stadtroda, Germany, 07646
Paracelsus-Elena Klinik
Kassel, Germany, 34128
Universitätskrankenhaus Eppendorf
Hamburg, Germany, 20251
Sweden
Nyköpings Lasarett, Ger/Rehabkliniken
Nyköping, Sweden, 61185
Visby lasarett, Neurologmottagningen
Visby, Sweden, 62184
Länsjukhuset Ryhov, Geriatriska Kliniken
Jönköping, Sweden, 55185
United Kingdom
Royal Sussex County Hospital, Neurology Department
Brighton, United Kingdom, BN2 5BE
United Kingdom, Dorset
The Royal Bournemouth Hospital, Department of Medicines for the Elderly
Bournemouth, Dorset, United Kingdom, BH7 7DW
United Kingdom, Tyne and Wear
North Tyneside General Hospital, Department of Medicine
North Shields, Tyne and Wear, United Kingdom, NE29 8NH

Sponsors and Collaborators

Orion Corporation, Orion Pharma

Investigators

Principal Investigator:

Wolfgang H. Oertel, Professor

Universitätsklinikum Giessen und Marburg GmbH

More Information

No publications provided

Responsible Party:	Orion Pharma ( Liisa Luotonen )
Study ID Numbers:	2939117
Study First Received:	April 17, 2007
Last Updated:	February 5, 2008
ClinicalTrials.gov Identifier:	NCT00462007 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; Germany: Federal Institute for Drugs and Medical Devices; Denmark: Danish Medicines Agency; Sweden: Medical Products Agency

Additional relevant MeSH terms:

Movement Disorders
Parkinson Disease
Nervous System Diseases
Basal Ganglia Diseases

Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

ClinicalTrials.gov processed this record on November 30, 2009