Clinical trial NCT00125567: Stalevo in Early Wearing-Off Patients
Official title: Multicentre, Randomised, Double-Blind Study to Compare Stalevo to Levodopa/Carbidopa in Patients With Parkinson's Disease Experiencing Symptoms of Early Wearing-Off
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Idiopathic Parkinson's Disease
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2005-08-01
Enrollment: 223
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate in patients with Parkinson's disease that, when compared to levodopa/carbidopa, Stalevo will delay the time from initiation of study drug to the time an increase in antiparkinsonian medication is required due to inadequately controlled parkinsonian symptoms.


Eligibility criteria: Inclusion Criteria:

* Idiopathic Parkinson's disease
* Treatment with 3 equal daily doses of levodopa/carbidopa up to 450 mg/day
* Unchanged antiparkinsonian medication for 6 weeks prior to baseline

Exclusion Criteria:

* Secondary or atypical parkinsonism
* Patients with daily unpredictable OFF periods or painful dyskinesia

Primary outcomes:
measure: The time until a patient requires changes in antiparkinsonian therapy due to inadequately controlled parkinsonian symptoms
timeFrame: Up to 2 years of treatment
Secondary outcomes:
measure: Unified Parkinson's Disease Rating Scale
timeFrame: Up to 2 years of treatment
measure: Clinical Global Impression of Change (investigator)
timeFrame: Up to 2 years of treatment
measure: Parkinson's Disease Questionnaire (PDQ-39)
timeFrame: Up to 2 years of treatment
measure: Work Impairment Questionnaire
timeFrame: Up to 2 years of treatment
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg Hospital
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
city: Nørrebrogade 44
country: Denmark
facility: Århus Kommunehospital
city: Lappeenranta
country: Finland
facility: South Karelia Central Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Bad Nauheim
country: Germany
facility: Parkinson Klinik Bad Nauheim
city: Bad Neustadt
country: Germany
facility: Neurologische Klinik Bad Neustadt
city: Duesseldorf
country: Germany
facility: Neurologische Klinik der Universitat Dusseldorf
city: Hamburg
country: Germany
facility: Allgemeines Krankenhaus Harburg
city: Ulm
country: Germany
facility: Praxis Drs Lang, Krauss, Schreiber
city: Dublin
country: Ireland
facility: Mater Private Hospital
city: Malmö
country: Sweden
facility: Universitetssjukhuset MAS
city: Vällingby
country: Sweden
facility: Läkarhuset Vällingby
city: Chertsey
country: United Kingdom
facility: Movement Disorder Services
state: Surrey
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
state: Wales
city: Rhyl
country: United Kingdom
facility: Glan Clwyd Hospital
state: Wales
city: Bristol
country: United Kingdom
facility: Frenchay Hospital
city: Leigh
country: United Kingdom
facility: Leigh Infirmary
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
affiliation: Orion Corporation, Orion Pharma
name: Andrew Wighton, BSc (Hons)
role: STUDY_DIRECTOR
affiliation: University Hospital of Wales and Rookwood Hospital
name: Bhadravati SD Sastry, FRCP
role: PRINCIPAL_INVESTIGATOR
References: