A Non-Blinded Study Demonstrating the Effectiveness and Safety of Azilect Alone or in Combination Therapy in Parkinson's Disease
Open-label, Multicenter, Effectiveness and Safety Study of Once Daily AZILECT® as Mono- or Adjunct Therapy in Patients With Idiopathic Parkinson's Disease (PD)
1 other identifier
interventional
200
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2006
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 10, 2006
CompletedFirst Posted
Study publicly available on registry
November 14, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedApril 12, 2011
April 1, 2011
9 months
November 10, 2006
April 8, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
To identify the earliest scheduled visit of symptomatic effect
8 months
Secondary Outcomes (1)
To characterize the effectiveness of Azilect in a usual community neurological
8 months
Study Arms (2)
Rasagiline mesylate
ACTIVE COMPARATORRasagiline mesylate plus adjunct therapy
EXPERIMENTALRasagiline mesylate with one of three adjunct therapies
Interventions
Eligibility Criteria
You may qualify if:
- 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..
You may not qualify if:
- Patients previously exposed to Azilect
- Patients with pheochromocytoma
- Concomitant MAO inhibitors or medications contraindicated for use with MAO inhibitors are not allowed.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MerriKay Oleen-Burkey, PhD
Teva Neuroscience, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 10, 2006
First Posted
November 14, 2006
Study Start
October 1, 2006
Primary Completion
July 1, 2007
Study Completion
July 1, 2007
Last Updated
April 12, 2011
Record last verified: 2011-04