Azilect® In Wearing-Off (AIWO)

Overview

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.

Full Title of Study: “Azilect® In Wearing-Off (AIWO) Non-interventional Study on Efficacy and Tolerability of Rasagiline (1mg/d) add-on in Ambulatory Parkinson’s Disease Patients With Wearing-off Symptoms Diagnosed by Wearing-off Questionnaire (WOQ-32)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2014

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).

Interventions

  • Drug: Azilect®
    • AZILECT® 1mg Tablets

Clinical Trial Outcome Measures

Primary Measures

  • Wearing-off Questionnaire-32 (WOQ-32)
    • Time Frame: 12 weeks
    • Alterations of 32 different wearing-off symptoms (Patient questionnaire)

Secondary Measures

  • WHO-5
    • Time Frame: 12 weeks
    • Alterations of patient’s Quality of life (patient questionnaire)
  • GI-I
    • Time Frame: 12 weeks
    • Self-Assessment of global improvement (patient questionnaire)
  • Columbia University Rating Scale (CURS)
    • Time Frame: 12 weeks
    • Alteration of PD symptoms (physician rated questionnaires)
  • Clinical global impression improvement (CGI-I)
    • Time Frame: 12 weeks
    • (physician rated questionnaires)
  • Percentage of participants with adverse events
    • Time Frame: 12 weeks

Participating in This Clinical Trial

Inclusion:

  • idiopathic Parkinson's disease based on the UK Brain Bank criteria, – Wearing-off / end-of-dose akinesia – at least 18 years old, – written consent to participate in the study. Exclusion: – contraindications according to the SmPC of Azilect®, – treatment with Azilect® in the past 3 months and / or – suffering from a relevant cognitive impairment and therefore neither understand the patient information, nor can give their consent to participate.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Teva Pharma GmbH
  • Collaborator
    • Anfomed GmbH
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Expert, MD, Study Director, Paracelsus-Elena-Klinik Kassel

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