Rasagiline in Advanced Parkinson's Disease Patients With Motor Fluctuations Treated With Levodopa/Carbidopa Therapy.
This study has been completed.
Sponsor:
Teva Pharmaceutical Industries
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00203177
First received: September 13, 2005
Last updated: March 8, 2010
Last verified: March 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson's Disease |
Drug: rasagiline mesylate Drug: rasagiline mesylate 1.0 mg |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Further study details as provided by Teva Pharmaceutical Industries:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Enrollment: | 254 |
| Study Start Date: | October 2001 |
| Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Experimental 1
0.5 mg rasagiline mesylate oral once daily
|
Drug: rasagiline mesylate
0.5 rasagiline mesylate
|
|
Experimental: Expermental 2
1.0 mg rasagiline mesylate oral once daily
|
Drug: rasagiline mesylate 1.0 mg
1.0 mg rasagiline mesylate
|
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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, metabolic diseases or malignancies as determined by medical history, physical exam, skin evaluation, laboratory tests, chest x-ray, or ECG.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00203177
Locations
| United States, California | |
| Margolin Brain Institute | |
| Fresno, California, United States, 93720 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30329 | |
| United States, Illinois | |
| Rush - Presbyterian St. Luke's Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| United States, Nebraska | |
| Creighton University | |
| Omaha, Nebraska, United States, 68131 | |
| United States, New York | |
| Long Island Jewish Medical Center | |
| New Hyde Park, New York, United States, 11040 | |
| University of Rochester | |
| Rochester, New York, United States, 14642 | |
| United States, Pennsylvania | |
| Pennsylvania Hospital | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Canada, Quebec | |
| CHUM-Hotel-Dieu | |
| Montreal, Quebec, Canada, H2w1T8 | |
Sponsors and Collaborators
Teva Pharmaceutical Industries
Investigators
| Study Director: | Phyllis Salzman, Ph.D. | Teva Neuroscience, Inc. |
More Information
No publications provided
| Responsible Party: | Siyu Liu, MD, PhD, VP IR&D, Head of Global Clinical Operations, Teva Branded Pharmaceutical Products IR&D |
| ClinicalTrials.gov Identifier: | NCT00203177 History of Changes |
| Other Study ID Numbers: | TVP - 1012/135 Double Blind |
| Study First Received: | September 13, 2005 |
| Last Updated: | March 8, 2010 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Carbidopa Levodopa Rasagiline Antiparkinson Agents |
Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Dopamine Agents Neurotransmitter Agents Physiological Effects of Drugs Monoamine Oxidase Inhibitors Neuroprotective Agents Protective Agents |
ClinicalTrials.gov processed this record on May 21, 2013