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Study to Evaluate Initiation of Stalevo in Early Wearing-Off (SENSE)
This study has been completed.
Study NCT00462007   Information provided by Orion Corporation, Orion Pharma
First Received: April 17, 2007   Last Updated: February 5, 2008   History of Changes

April 17, 2007
February 5, 2008
September 2006
August 2007   (final data collection date for primary outcome measure)
Clinical Global Impression of Change (Patient) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Clinical Global Impression of Change (Patient)
Complete list of historical versions of study NCT00462007 on ClinicalTrials.gov Archive Site
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 ]
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
 
Study to Evaluate Initiation of Stalevo in Early Wearing-Off
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

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'.

Phase IV
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Parkinson's Disease
Drug: Stalevo
Experimental: Stalevo
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
115
December 2007
August 2007   (final data collection date for primary outcome measure)

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.
Both
35 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Sweden,   United Kingdom
 
NCT00462007
Liisa Luotonen, Orion Pharma
2939117
Orion Corporation, Orion Pharma
 
Principal Investigator: Wolfgang H. Oertel, Professor Universitätsklinikum Giessen und Marburg GmbH
Orion Corporation, Orion Pharma
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP