Clinical Trial of Rasagiline in Levodopa-Treated Parkinson's Disease Patients With Motor Fluctuations

This study has been completed.
Sponsor:
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: September 12, 2013
Last verified: November 2012
  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: 0, 14 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline to week 6/10/16 in mean total daily OFF time measured by patients' home diaries. [ Time Frame: 0, 6, 10, 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: 0, 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: 0, 6, 14, 16 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to week 6/10/14/16 in mean total daily ON time measured by patients' home diaries. [ Time Frame: 0, 6, 10, 14, 16 weeks ] [ Designated as safety issue: No ]
  • Analysis of the changing rate of the UPDRSⅡ -Ⅵ after treatment of week 6/14/16. [ Time Frame: 0, 6, 14, 16 weeks ] [ Designated as safety issue: No ]
  • The rate of patients whose Levodopa dose is adjusted after 6/14/16 weeks of treatment. [ Time Frame: 0, 2, 6, 14, 16 weeks ] [ Designated as safety issue: No ]
  • BP、 temperature、 breath and heart rate after 5 minutes of stasis. [ Time Frame: -2, 0, 2, 6, 10, 14, 16 weeks ] [ Designated as safety issue: Yes ]
  • Physical examination. [ Time Frame: -2, 16 weeks ] [ Designated as safety issue: Yes ]
  • Adverse Events: the occurrence of melanoma. [ Time Frame: 0, 2, 6, 10, 14, 16 weeks ] [ Designated as safety issue: Yes ]
  • Grade of UPDRS I [ Time Frame: 0, 6, 14, 16 weeks ] [ Designated as safety issue: Yes ]
  • Blood routine、 urine routine、 ALT、 AST、 TBiL、 γ-GTP、 ALP、 BUN、 Cr、 ECG. [ Time Frame: 0, 6, 16 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 268
Study Start Date: November 2011
Study Completion Date: June 2013
Primary Completion Date: June 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 0.5mg 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 0.5mg 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01736891

Locations
China
CN002
Chengdu, China, 610041
CN005
Chenzhou, China, 423000
CN007
Chongqing, China, 404000
CN003
Guilin, China, 541001
CN004
Lanzhou, China, 730050
CN006
Luzhou, China, 646000
CN008
Nanjing, China, 210029
CN001
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: September 12, 2013
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 August 19, 2014