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

Sponsor:	Teva Pharmaceutical Industries
Information provided by:	Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:	NCT00399477

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: Azilect (rasagiline mesylate) Drug: Mirapex Drug: Levodopa Drug: Requip	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Levodopa Rasagiline Rasagiline mesylate

U.S. FDA Resources

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:

To identify the earliest scheduled visit at which the symptomatic effect of
Azilect as initial monotherapy and as adjunct therapy can be demonstrated

Secondary Outcome Measures:

To characterize the effectiveness of Azilect in a usual community neurological
practice by assessing investigator and patient-rated satisfaction and ease-of-use.

Estimated Enrollment:	200
Study Start Date:	October 2006
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Detailed Description:

Open-label, multicentered Two hundred-fifty (250) enrolled patients will be stratified within each center by absence/presence of concomitant dopaminergic therapy

Azilect as monotherapy: Patients not currently receiving LD/CD or a dopamine agonist; Azilect as first line dopaminergic PD treatment
Azilect as adjunct therapy: Patients already receiving LD/CD and/or dopamine agonist
Approx. 1:1 ratio of mono- to adjunct therapy, for the study overall. Visits at Screening/Baseline, Weeks 1, 2, 4, and 12. Telephone contact at Week 8.

PD symptom scales, satisfaction/ease-of-use ratings, global evaluations and safety assessments to be completed by investigator and/or patient at baseline and at specified visits during the study.

For patients receiving Azilect as adjunct therapy, the use and dose changes of LD/CD and /or dopamine agonists will be recorded in detail.

Eligibility

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

Criteria

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.

Contacts and Locations

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

Show 40 Study Locations

Sponsors and Collaborators

Teva Pharmaceutical Industries

Investigators

Study Director:

MerriKay Oleen-Burkey, PhD

Teva Neuroscience, Inc.

More Information

No publications provided

Study ID Numbers:	TVP-1012/PM101
Study First Received:	November 10, 2006
Last Updated:	April 3, 2009
ClinicalTrials.gov Identifier:	NCT00399477 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Rasagiline
Molecular Mechanisms of Pharmacological Action
Basal Ganglia Diseases
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Diseases
Enzyme Inhibitors
Brain Diseases
Neurodegenerative Diseases

Neuroprotective Agents
Protective Agents
Pharmacologic Actions
Parkinson Disease
Movement Disorders
Therapeutic Uses
Monoamine Oxidase Inhibitors
Parkinsonian Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009