Clinical trial NCT00462007: Study to Evaluate Initiation of Stalevo in Early Wearing-off
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson's Disease
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2007-04-18
Enrollment: 115
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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'.

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.

Primary outcomes:
measure: Clinical Global Impression of Change (Patient)
timeFrame: 6 weeks
Secondary outcomes:
measure: 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
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Humboldt Universität Charité Neurologische Klinik
city: Bochum
country: Germany
facility: St. Josef-Hospital, Klinikum der Ruhr-Universität-Bochum Neurologische Klinik
city: Chemnitz
country: Germany
facility: Pharmakologisches Studienzentrum Chemnitz
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus Klinik und Poliklinik für Neurologie
city: Erbach
country: Germany
facility: Gemeinschaftspraxis für Neurologie & Psychiatrie
city: Giessen
country: Germany
facility: Neurologische Praxis Dr Christine Schuster
city: Hamburg
country: Germany
facility: Universitätskrankenhaus Eppendorf
city: Kassel
country: Germany
facility: Paracelsus-Elena Klinik
city: Krefeld
country: Germany
facility: Alexianer-Krankenhaus
city: Köln
country: Germany
facility: Nervenarztpraxis Dr Alexander Nass
city: Marburg
country: Germany
facility: Universitätsklinikum Gießen und Marburg GmbH
city: Stadtroda
country: Germany
facility: Asklepios Fachklinikum Stadtroda
city: Tübingen
country: Germany
facility: Eberhard-Karls-Universität, Universitätsklinikum Tübingen, Zentrum für Neurologie
city: Ulm
country: Germany
facility: Neurologische Klinik der Universität Ulm
city: Jönköping
country: Sweden
facility: Länsjukhuset Ryhov, Geriatriska Kliniken
city: Nyköping
country: Sweden
facility: Nyköpings Lasarett, Ger/Rehabkliniken
city: Visby
country: Sweden
facility: Visby lasarett, Neurologmottagningen
city: Bournemouth
country: United Kingdom
facility: The Royal Bournemouth Hospital, Department of Medicines for the Elderly
state: Dorset
city: North Shields
country: United Kingdom
facility: North Tyneside General Hospital, Department of Medicine
state: Tyne and Wear
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital, Neurology Department
Study officials:
affiliation: Universitätsklinikum Giessen und Marburg GmbH
name: Wolfgang H. Oertel, Professor
role: PRINCIPAL_INVESTIGATOR
References: