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

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)

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.

Study Overview

• Status: Completed
• Conditions: Parkinson´s Disease
• Intervention / Treatment: Drug: Rasagiline; Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 268
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Chengdu, China, 610041
    • CN002
  • Chenzhou, China, 423000
    • CN005
  • Chongqing, China, 404000
    • CN007
  • Guilin, China, 541001
    • CN003
  • Lanzhou, China, 730050
    • CN004
  • Luzhou, China, 646000
    • CN006
  • Nanjing, China, 210029
    • CN008
  • Xi'an, China, 710032
    • CN001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	0, 14 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline to week 6/10/16 in mean total daily OFF time measured by patients' home diaries.	0, 6, 10, 16 weeks
Change from baseline to week 6/14/16 in mean total daily ON time measured by patients' home diaries.	0, 6, 14, 16 weeks
Change from baseline to week 6/14/16 on Unified Parkinson's Disease Rating Scale (UPDRS) Ⅱ- Ⅵ Activities of Daily Living.	0, 6, 14, 16 weeks
Change from baseline to week 6/10/14/16 in mean total daily ON time measured by patients' home diaries.	0, 6, 10, 14, 16 weeks
Analysis of the changing rate of the UPDRSⅡ -Ⅵ after treatment of week 6/14/16.	0, 6, 14, 16 weeks
The rate of patients whose Levodopa dose is adjusted after 6/14/16 weeks of treatment.	0, 2, 6, 14, 16 weeks
BP、 temperature、 breath and heart rate after 5 minutes of stasis.	-2, 0, 2, 6, 10, 14, 16 weeks
Physical examination.	-2, 16 weeks
Adverse Events: the occurrence of melanoma.	0, 2, 6, 10, 14, 16 weeks
Grade of UPDRS I	0, 6, 14, 16 weeks
Blood routine、 urine routine、 ALT、 AST、 TBiL、 γ-GTP、 ALP、 BUN、 Cr、 ECG.	0, 6, 16 weeks

Collaborators and Investigators

• Sponsor: Chongqing Fortune Pharmaceutical Co., Ltd.
• Collaborators: Beijing Bionovo Medicine Development Co., Ltd.
• Investigators: Principal Investigator: Gang Zhao, The First Affiliated Hospital of the Fourth Military Medical University

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: November 27, 2012
• First Submitted That Met QC Criteria: November 28, 2012
• First Posted (Estimate): November 29, 2012

Study Record Updates

• Last Update Posted (Estimate): September 13, 2013
• Last Update Submitted That Met QC Criteria: September 12, 2013
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Rasagiline; Motor fluctuations; Parkinson´s Disease
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Neuroprotective Agents; Protective Agents; Monoamine Oxidase Inhibitors; Rasagiline
• Other Study ID Numbers: RLPDMF2010L03416