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OpenTrials
Completed

NCT Number: NCT00399477

A Non-Blinded Study Demonstrating the Effectiveness and Safety of Azilect Alone or in Combination Therapy in Parkinson's Disease

Patients with Parkinson's Disease (PD) will be divided into 2 groups at each study center at their first visit based on the drugs they are taking for their PD:

* Group 1 Patients using Azilect and no other therapy. * Group 2 Azilect in combination with other medications like Levodopa, Mirapex, or Requip.

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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

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Idiopathic Parkinson's disease. Diagnosis previously confirmed by the presence of bradykinesia and by at least one additional cardinal sign (i.e., resting tremor, rigidity), without other known or suspected cause of parkinsonism.
  • Requiring therapy for PD symptom control
  • Azilect monotherapy.
  • Azilect as adjunct therapy..

Exclusion criteria

  • Patients previously exposed to Azilect
  • Patients with pheochromocytoma
  • Concomitant MAO inhibitors or medications contraindicated for use with MAO inhibitors are not allowed.

Treatment and study plan

rasagiline mesylate

Drug

Azilect®

Rasagiline mesylate plus Mirapex

Drug

Mirapex, Azilect®

Rasagiline mesylate with Levodopa

Drug

Azilect®, Levodopa

Rasagiline mesylate with Requip

Drug

Azilect®, Requip

Primary outcomes

  1. To identify the earliest scheduled visit of symptomatic effect

    Time frame: 8 months

Secondary outcomes

  1. To characterize the effectiveness of Azilect in a usual community neurological

    Time frame: 8 months

Sponsors and collaborators

Lead sponsor

Teva Neuroscience, Inc.

Industry

Registry information

Official study title

Open-label, Multicenter, Effectiveness and Safety Study of Once Daily AZILECT® as Mono- or Adjunct Therapy in Patients With Idiopathic Parkinson's Disease (PD)

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Nov 14, 2006
Registry last updated
Apr 12, 2011

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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