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Rasagiline in Advanced Parkinson's Disease Patients With Motor Fluctuations Treated With Levodopa/Carbidopa Therapy.

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00203177
First received: September 13, 2005
Last updated: March 8, 2010
Last verified: March 2010
History of Changes

September 13, 2005
March 8, 2010
October 2001
December 2006   (final data collection date for primary outcome measure)
long-term safety and tolerability of rasagiline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
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.
Complete list of historical versions of study NCT00203177 on ClinicalTrials.gov Archive Site
long- term clinical effect of rasagiline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
To assess the long- term clinical effect of rasagiline on the course of the disease.
Not Provided
Not Provided
Not Provided
 
Rasagiline in Advanced Parkinson's Disease Patients With Motor Fluctuations Treated With Levodopa/Carbidopa Therapy.
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 to look at the effectiveness, tolerability and safety of two doses of Rasagiline (0.5 mg and 1mg) in advanced Parkinson's Disease (PD) Patients who have been treated with Levodopa/Carbidopa therapy.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Parkinson's Disease
  • Drug: rasagiline mesylate
    0.5 rasagiline mesylate
  • Drug: rasagiline mesylate 1.0 mg
    1.0 mg rasagiline mesylate
  • Experimental: Experimental 1
    0.5 mg rasagiline mesylate oral once daily
    Intervention: Drug: rasagiline mesylate
  • Experimental: Expermental 2
    1.0 mg rasagiline mesylate oral once daily
    Intervention: Drug: rasagiline mesylate 1.0 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
254
Not Provided
December 2006   (final data collection date for primary outcome measure)

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, metabolic diseases or malignancies as determined by medical history, physical exam, skin evaluation, laboratory tests, chest x-ray, or ECG.
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00203177
TVP - 1012/135 Double Blind
Yes
Siyu Liu, MD, PhD, VP IR&D, Head of Global Clinical Operations, Teva Branded Pharmaceutical Products IR&D
Teva Pharmaceutical Industries
Not Provided
Study Director: Phyllis Salzman, Ph.D. Teva Neuroscience, Inc.
Teva Pharmaceutical Industries
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP