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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:
ClinicalTrials.gov Identifier:
NCT00203177
First Posted: September 20, 2005
Last Update Posted: March 9, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Teva Pharmaceutical Industries
September 13, 2005
September 20, 2005
March 9, 2010
October 2001
December 2006   (Final data collection date for primary outcome measure)
long-term safety and tolerability of rasagiline [ Time Frame: 6 months ]
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 ]
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Sexes Eligible for Study: All
30 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00203177
TVP - 1012/135 Double Blind
Yes
Not Provided
Not Provided
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