Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
See 'Brief summary'.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Stalevo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stalevo | Drug | Oral 3-4 daily doses for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression of Change (Patient) | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Wolfgang H. Oertel, Professor | Universitätsklinikum Giessen und Marburg GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humboldt Universität Charité Neurologische Klinik | Berlin | 10098 | Germany | |||
| St. Josef-Hospital, Klinikum der Ruhr-Universität-Bochum Neurologische Klinik |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Bochum |
| 44791 |
| Germany |
| Pharmakologisches Studienzentrum Chemnitz | Chemnitz | 09111 | Germany |
| Nervenarztpraxis Dr Alexander Nass | Cologne | 51069 | Germany |
| Universitätsklinikum Carl Gustav Carus Klinik und Poliklinik für Neurologie | Dresden | 01307 | Germany |
| Gemeinschaftspraxis für Neurologie & Psychiatrie | Erbach im Odenwald | 64711 | Germany |
| Neurologische Praxis Dr Christine Schuster | Giessen | 35390 | Germany |
| Universitätskrankenhaus Eppendorf | Hamburg | 20251 | Germany |
| Paracelsus-Elena Klinik | Kassel | 34128 | Germany |
| Alexianer-Krankenhaus | Krefeld | 47805 | Germany |
| Universitätsklinikum Gießen und Marburg GmbH | Marburg | D-35039 | Germany |
| Asklepios Fachklinikum Stadtroda | Stadtroda | 07646 | Germany |
| Eberhard-Karls-Universität, Universitätsklinikum Tübingen, Zentrum für Neurologie | Tübingen | 72076 | Germany |
| Neurologische Klinik der Universität Ulm | Ulm | 89081 | Germany |
| Länsjukhuset Ryhov, Geriatriska Kliniken | Jönköping | 55185 | Sweden |
| Nyköpings Lasarett, Ger/Rehabkliniken | Nyköping | 61185 | Sweden |
| Visby lasarett, Neurologmottagningen | Visby | 62184 | Sweden |
| The Royal Bournemouth Hospital, Department of Medicines for the Elderly | Bournemouth | Dorset | BH7 7DW | United Kingdom |
| North Tyneside General Hospital, Department of Medicine | North Shields | Tyne and Wear | NE29 8NH | United Kingdom |
| Royal Sussex County Hospital, Neurology Department | Brighton | BN2 5BE | United Kingdom |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C481098 | Stalevo |
Not provided
Not provided
Not provided