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

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00399477
First received: November 10, 2006
Last updated: April 8, 2011
Last verified: April 2011
  Purpose

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.

Condition Intervention Phase
Parkinson's Disease
Drug: rasagiline mesylate
Drug: Rasagiline mesylate plus Mirapex
Drug: Rasagiline mesylate with Levodopa
Drug: Rasagiline mesylate with Requip
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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)

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • To identify the earliest scheduled visit of symptomatic effect [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To characterize the effectiveness of Azilect in a usual community neurological [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: October 2006
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Rasagiline mesylate Drug: rasagiline mesylate
Azilect®
Experimental: Rasagiline mesylate plus adjunct therapy
Rasagiline mesylate with one of three adjunct therapies
Drug: Rasagiline mesylate plus Mirapex
Mirapex, Azilect®
Drug: Rasagiline mesylate with Levodopa
Azilect®, Levodopa
Drug: Rasagiline mesylate with Requip
Azilect®, Requip

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Requiring therapy for PD symptom control

    • Azilect monotherapy.
    • Azilect as adjunct therapy..

Exclusion Criteria:

  1. Patients previously exposed to Azilect
  2. Patients with pheochromocytoma
  3. Concomitant MAO inhibitors or medications contraindicated for use with MAO inhibitors are not allowed.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00399477

Sponsors and Collaborators
Teva Neuroscience, Inc.
Investigators
Study Director: MerriKay Oleen-Burkey, PhD Teva Neuroscience, Inc.
  More Information

No publications provided

Responsible Party: Thomas Smith, MD, Teva Neuroscience
ClinicalTrials.gov Identifier: NCT00399477     History of Changes
Other Study ID Numbers: TVP-1012/PM101
Study First Received: November 10, 2006
Last Updated: April 8, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Pramipexol
Ropinirole
Rasagiline
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Neuroprotective Agents
Protective Agents
Antioxidants
Dopamine Agonists

ClinicalTrials.gov processed this record on July 20, 2014