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CompletedNCT00399477Updated Apr 12, 2011

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

A Phase 4 interventional study of rasagiline mesylate and Rasagiline mesylate plus Mirapex in Parkinson's Disease, sponsored by Teva Neuroscience, Inc.. Completed. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2011-04-12.

Sponsored by Teva Neuroscience, Inc. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
200
Allocation
Non-randomized
Ages
30 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • Parkinson's Disease

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03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 200 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Teva Neuroscience, Inc. is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • Active comparator
    Rasagiline mesylate

    Drug: rasagiline mesylate

  • Experimental
    Rasagiline mesylate plus adjunct therapy

    Rasagiline mesylate with one of three adjunct therapies

    Drug: Rasagiline mesylate plus Mirapex · Drug: Rasagiline mesylate with Levodopa · Drug: Rasagiline mesylate with Requip

Interventions

  • Drugrasagiline mesylate

    Azilect®

  • DrugRasagiline mesylate plus Mirapex

    Mirapex, Azilect®

  • DrugRasagiline mesylate with Levodopa

    Azilect®, Levodopa

  • DrugRasagiline mesylate with Requip

    Azilect®, Requip

06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00399477
Lead sponsor
Teva Neuroscience, Inc.
First posted
Nov 14, 2006
Start date
Oct 2006
Primary completion
Jul 2007
Completion
Jul 2007
Last update
Apr 12, 2011

Study contacts

MerriKay Oleen-Burkey, PhD
study director · Teva Neuroscience, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.

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