Stalevo in Early Wearing-Off Patients

Idiopathic Parkinson's Disease Clinical Trial

— SEWOP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00125567
• Other study ID #: 2939111
• Secondary ID: EudraCT number:
• Status: Completed
• Phase: Phase 4
• First received: July 29, 2005
• Last updated: June 19, 2009
• Start date: August 2005
• Est. completion date: March 2009

Study information

• Verified date: June 2009
• 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 DevicesIreland: Irish Medicines BoardDenmark: Danish Medicines AgencySweden: Medical Products AgencyNorway: Norwegian Medicines AgencyFinland: Finnish Medicines AgencyLithuania: State Medicine Control Agency - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Idiopathic Parkinson's Disease
• Parkinson Disease

Intervention

Drug:
• Stalevo (levodopa/carbidopa/entacapone)
Oral, 50-150 mg levodopa four times daily, for up to 2 years
• Levodopa/carbidopa
Oral capsules, 50-150 mg levodopa four times daily, for up to 2 years

Locations

Country	Name	City	State
Denmark	Aalborg Hospital	Aalborg
Denmark	Bispebjerg Hospital	Copenhagen
Denmark	Århus Kommunehospital	Nørrebrogade 44
Finland	South Karelia Central Hospital	Lappeenranta
Finland	Tampere University Hospital	Tampere
Germany	Parkinson Klinik Bad Nauheim	Bad Nauheim
Germany	Neurologische Klinik Bad Neustadt	Bad Neustadt
Germany	Neurologische Klinik der Universitat Dusseldorf	Duesseldorf
Germany	Allgemeines Krankenhaus Harburg	Hamburg
Germany	Praxis Drs Lang, Krauss, Schreiber	Ulm
Ireland	Mater Private Hospital	Dublin
Sweden	Universitetssjukhuset MAS	Malmö
Sweden	Läkarhuset Vällingby	Vällingby
United Kingdom	Frenchay Hospital	Bristol
United Kingdom	University Hospital of Wales	Cardiff	Wales
United Kingdom	Movement Disorder Services	Chertsey	Surrey
United Kingdom	Leigh Infirmary	Leigh
United Kingdom	Glan Clwyd Hospital	Rhyl	Wales
United Kingdom	Southampton General Hospital	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
Orion Corporation, Orion Pharma

Countries where clinical trial is conducted

Denmark,  Finland,  Germany,  Ireland,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The time until a patient requires changes in antiparkinsonian therapy due to inadequately controlled parkinsonian symptoms		Up to 2 years of treatment	No
Secondary	Unified Parkinson's Disease Rating Scale		Up to 2 years of treatment	No
Secondary	Clinical Global Impression of Change (investigator)		Up to 2 years of treatment	No
Secondary	Parkinson's Disease Questionnaire (PDQ-39)		Up to 2 years of treatment	No
Secondary	Work Impairment Questionnaire		Up to 2 years of treatment	No