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Study to Evaluate the Safety and Tolerability of Rasagiline in Advanced Parkinson's Disease Patients

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
rasagiline mesylate
Sponsored by
Teva Branded Pharmaceutical Products R&D, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients must have completed the Week 26 visit of TVP 1012/133 (Visit 06) in accordance with the protocol. Women must be postmenopausal, surgically sterile, or using adequate birth control methods. Women of childbearing potential must have a negative pregnancy test at Baseline/Month 0. Patients must be willing and able to give informed consent. Exclusion Criteria: Serious or severe, test drug-related (probable or definite) adverse reaction in study TVP 1012/133. Premature discontinuation from study TVP 1012/133 for any reason. A clinically significant or unstable medical or surgical condition which would preclude safe and complete study participation. Such conditions may include cardiovascular, pulmonary, hepatic, renal, or metabolic diseases; or malignancies, as determined by medical history, physical exam, skin evaluation, laboratory tests, chest x-ray, or electrocardiogram (ECG).

Sites / Locations

  • Margolin Brain Institute
  • Rush - Presbyterian St. Luke's Medical Center
  • Creighton University
  • Long Island Jewish Medical Center
  • University of Rochester
  • Pennsylvania Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

rasagiline mesylate

Arm Description

rasagiline mesylate 1 mg oral once daily

Outcomes

Primary Outcome Measures

long-term safety and tolerability of rasagiline or levodopa/benserazide (LD/BZD) therapy
To evaluate the long-term safety and tolerability of rasagiline in PD patients with motor fluctuations treated with chronic levodopa/carbidopa (LD/CD) or levodopa/benserazide (LD/BZD) therapy

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
March 8, 2010
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00203164
Brief Title
Study to Evaluate the Safety and Tolerability of Rasagiline in Advanced Parkinson's Disease Patients
Official Title
A Bi-national, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Tolerability of Rasagiline Mesylate in Advanced Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Chronic Levodopa/Carbidopa Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a study to look at the effectiveness, tolerability, and safety of one dose of rasagiline in advanced Parkinson's disease (PD) patients who have been treated with Levodopa/Carbidopa therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
254 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rasagiline mesylate
Arm Type
Experimental
Arm Description
rasagiline mesylate 1 mg oral once daily
Intervention Type
Drug
Intervention Name(s)
rasagiline mesylate
Intervention Description
rasagiline mesylate 1 mg oral once daily
Primary Outcome Measure Information:
Title
long-term safety and tolerability of rasagiline or levodopa/benserazide (LD/BZD) therapy
Description
To evaluate the long-term safety and tolerability of rasagiline in PD patients with motor fluctuations treated with chronic levodopa/carbidopa (LD/CD) or levodopa/benserazide (LD/BZD) therapy
Time Frame
until commericially available

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have completed the Week 26 visit of TVP 1012/133 (Visit 06) in accordance with the protocol. Women must be postmenopausal, surgically sterile, or using adequate birth control methods. Women of childbearing potential must have a negative pregnancy test at Baseline/Month 0. Patients must be willing and able to give informed consent. Exclusion Criteria: Serious or severe, test drug-related (probable or definite) adverse reaction in study TVP 1012/133. Premature discontinuation from study TVP 1012/133 for any reason. A clinically significant or unstable medical or surgical condition which would preclude safe and complete study participation. Such conditions may include cardiovascular, pulmonary, hepatic, renal, or metabolic diseases; or malignancies, as determined by medical history, physical exam, skin evaluation, laboratory tests, chest x-ray, or electrocardiogram (ECG).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phyllis Salzman, Ph.D.
Organizational Affiliation
Teva Neuroscience, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Margolin Brain Institute
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Rush - Presbyterian St. Luke's Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Creighton University
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Long Island Jewish Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

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Study to Evaluate the Safety and Tolerability of Rasagiline in Advanced Parkinson's Disease Patients

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