Clinical Trial of Rasagiline in Levodopa-Treated Parkinson's Disease Patients With Motor Fluctuations
This study is currently recruiting participants.
Verified November 2012 by Chongqing Fortune Pharmaceutical Co., Ltd.
Sponsor:
Chongqing Fortune Pharmaceutical Co., Ltd.
Collaborator:
Beijing Bionovo Medicine Development Co., Ltd.
Information provided by (Responsible Party):
Chongqing Fortune Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01736891
First received: November 27, 2012
Last updated: December 10, 2012
Last verified: November 2012
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Purpose
The objective of this study is to evaluate the efficacy, tolerability, and safety of rasagiline compared to placebo in PD patients with motor fluctuations on levodopa therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson´s Disease |
Drug: Rasagiline Drug: Placebo |
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: | Evaluation for the Efficacy,Tolerability,and Safety of Rasagiline in Levodopa-treated PD Patients With Motor Fluctuations: A Multicenter, Double Blind, Randomized, Placebo-Controlled Group Study (China) |
Resource links provided by NLM:
Further study details as provided by Chongqing Fortune Pharmaceutical Co., Ltd.:
Primary Outcome Measures:
- Efficacy of rasagiline vs placebo as assessed by the change from baseline to week 14 in mean total daily OFF time measured by patients' home diaries in levodopa-treated PD patients with motor fluctuations [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- change from baseline to week 6/16 in mean total daily OFF time measured by patients' home diaries [ Time Frame: 6, 14, 16 weeks ] [ Designated as safety issue: No ]
- change from baseline to week 6/14/16 in mean total daily ON time measured by patients' home diaries [ Time Frame: 6, 14, 16 weeks ] [ Designated as safety issue: No ]
- Change from baseline to week 6/14/16 on Unified Parkinson's Disease Rating Scale (UPDRS) Ⅱ- Ⅵ Activities of Daily Living; [ Time Frame: 6, 14, 16 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 272 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Rasagiline
Rasagiline 0.5 mg by mouth every day for 2 weeks, then 1 mg by mouth every day for 12 weeks, then switch to 1mg by mouth every day for remainder of the study (approximately 16 weeks total)
|
Drug: Rasagiline
Tablets, qd
Other Name: Azilect
|
|
Placebo Comparator: Placebo
placebo 0.5 mg by mouth every day for two weeks, then 1 mg by mouth every day for 12 weeks, then switch to 1 mg by mouth every day for remainder of the study (approximately 16 weeks total)
|
Drug: Placebo
Tablets, qd
Other Name: placebo
|
Detailed Description:
Levodopa has been the mainstay therapy for PD for decades, and it is considered to be one of the most effective medications for relief of the symptoms of PD. However, within few months to few years the majority of levodopa-treated patients notice a decline in the duration of benefit of each dose and develop motor-complications. A major problem is the appearance of fluctuations in mobility, cycles of ON and OFF periods. The administration of rasagiline, a MAO-B inhibitor, can slow the elimination of the endogenous dopamine supplies or the dopamine produced from the exogenous levodopa therapy and may therefore improve ON-OFF fluctuations.
The objective of this study is to evaluate the efficacy, tolerability, and safety of rasagiline compared to placebo in PD patients with motor fluctuations on levodopa therapy.
Eligibility| Ages Eligible for Study: | 30 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with idiopathic PD
- Patients receiving at least 300 mg daily doses of levodopa and not less than 8 daily doses of levodopa with the stable dose
- Patient with a Modified Hoehn and Yahr stage between 2 to 4 in the OFF state
- Patient with motor fluctuations averaging at least 2 hour daily in the OFF state
- Patients who have demonstrated the ability to keep accurate 24-hour diaries
Exclusion Criteria:
- Patients with Parkinsonian syndrome induced by medicine, metabolic disease, Encephalitis and central nervous system degenerative diseases or Disease of basal ganglia
- Patients with severe cognitive impairment judged by a Mini Mental State Examination
- Patients with a clinically significant psychiatric illness
- Patients with Hamilton Depression Rating Scale (HAMD): total score ≤10
- Patients with a clinically significant or unstable medical or surgical condition which would preclude safe and complete study participation
- Patients with a clinically significant or unstable vascular disease
- Patients with severe disabling dyskinesias Other inclusion and exclusion criteria may apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01736891
Contacts
| Contact: Mao Wang | 0086-023-67622236 | wangmao75@yahoo.com.cn |
Locations
| China | |
| CN002 | Recruiting |
| Chengdu, China, 610041 | |
| CN005 | Recruiting |
| Chenzhou, China, 423000 | |
| CN007 | Recruiting |
| Chongqing, China, 404000 | |
| CN003 | Recruiting |
| Guilin, China, 541001 | |
| CN004 | Recruiting |
| Lanzhou, China, 730050 | |
| CN006 | Recruiting |
| Luzhou, China, 646000 | |
| CN001 | Recruiting |
| Xi'an, China, 710032 | |
Sponsors and Collaborators
Chongqing Fortune Pharmaceutical Co., Ltd.
Beijing Bionovo Medicine Development Co., Ltd.
Investigators
| Principal Investigator: | Gang Zhao | the First Affiliated Hospital of the Fourth Military Medical University |
More Information
No publications provided
| Responsible Party: | Chongqing Fortune Pharmaceutical Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT01736891 History of Changes |
| Other Study ID Numbers: | RLPDMF2010L03416 |
| Study First Received: | November 27, 2012 |
| Last Updated: | December 10, 2012 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Chongqing Fortune Pharmaceutical Co., Ltd.:
|
Motor fluctuations Parkinson´s Disease Rasagiline |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Levodopa Rasagiline Antiparkinson Agents Anti-Dyskinesia Agents |
Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Monoamine Oxidase Inhibitors Enzyme Inhibitors Neuroprotective Agents Protective Agents |
ClinicalTrials.gov processed this record on May 16, 2013