Azilect® In Wearing-Off (AIWO)
- Conditions
- Parkinson's Disease
- Registration Number
- NCT02384512
- Lead Sponsor
- Teva Pharma GmbH
- Brief Summary
End-of-dose fluctuations e. g. wearing-off are defined as a recurrence of motor and non-motor Parkinson's Disease (PD) symptoms that precedes a scheduled dose and improves with the next dose of anti-parkinsonian medication. Azilect® is approved and recommended for therapy of wearing-off-/End-of-dose fluctuations and improves motor fluctuations significantly in combination therapy with L-dopa and other parkinsonian medication.
- Detailed Description
The aim of the non-interventional study is to document efficacy and tolerability of rasagiline as a combination therapy in patients with wearing-off-/End-of-dose fluctuations and the effect of rasagiline on individual wearing-off symptoms, recognized by wearing-off questionnaire 32 (WOQ-32).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 261
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Wearing-off Questionnaire-32 (WOQ-32) 12 weeks Alterations of 32 different wearing-off symptoms (Patient questionnaire)
- Secondary Outcome Measures
Name Time Method WHO-5 12 weeks Alterations of patient's Quality of life (patient questionnaire)
GI-I 12 weeks Self-Assessment of global improvement (patient questionnaire)
Columbia University Rating Scale (CURS) 12 weeks Alteration of PD symptoms (physician rated questionnaires)
Clinical global impression improvement (CGI-I) 12 weeks (physician rated questionnaires)
Percentage of participants with adverse events 12 weeks
Trial Locations
- Locations (1)
Teva Investigational Sites
🇩🇪Zwickau, Germany