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Completed

NCT Number: NCT02384512

Azilect® In Wearing-Off (AIWO)

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Teva Investigational Sites, Aalen, Germany

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Azilect®

Drug

AZILECT® 1mg Tablets

Other names: Rasagiline

Primary outcomes

  1. Wearing-off Questionnaire-32 (WOQ-32)

    Time frame: 12 weeks

    Alterations of 32 different wearing-off symptoms (Patient questionnaire)

Secondary outcomes

  1. WHO-5

    Time frame: 12 weeks

    Alterations of patient's Quality of life (patient questionnaire)

  2. GI-I

    Time frame: 12 weeks

    Self-Assessment of global improvement (patient questionnaire)

  3. Columbia University Rating Scale (CURS)

    Time frame: 12 weeks

    Alteration of PD symptoms (physician rated questionnaires)

  4. Clinical global impression improvement (CGI-I)

    Time frame: 12 weeks

    (physician rated questionnaires)

  5. Percentage of participants with adverse events

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Teva Pharma GmbH

Industry

Collaborators

  • Anfomed GmbH

Registry information

Official study title

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)

Acronym: AIWO

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Mar 10, 2015
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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