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

Primary Purpose

Parkinson´s Disease

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Rasagiline
Placebo
Sponsored by
Chongqing Fortune Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson´s Disease focused on measuring Motor fluctuations, Parkinson´s Disease, Rasagiline

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CN002
  • CN005
  • CN007
  • CN003
  • CN004
  • CN006
  • CN008
  • CN001

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Rasagiline

Placebo

Arm Description

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)

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)

Outcomes

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.

Secondary Outcome Measures

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

Full Information

First Posted
November 27, 2012
Last Updated
September 12, 2013
Sponsor
Chongqing Fortune Pharmaceutical Co., Ltd.
Collaborators
Beijing Bionovo Medicine Development Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01736891
Brief Title
Clinical Trial of Rasagiline in Levodopa-Treated Parkinson's Disease Patients With Motor Fluctuations
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)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chongqing Fortune Pharmaceutical Co., Ltd.
Collaborators
Beijing Bionovo Medicine Development Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson´s Disease
Keywords
Motor fluctuations, Parkinson´s Disease, Rasagiline

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
268 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rasagiline
Arm Type
Experimental
Arm Description
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)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Rasagiline
Other Intervention Name(s)
Azilect
Intervention Description
Tablets, qd
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablets, qd
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
Analysis of the changing rate of the UPDRSⅡ -Ⅵ after treatment of week 6/14/16.
Time Frame
0, 6, 14, 16 weeks
Title
The rate of patients whose Levodopa dose is adjusted after 6/14/16 weeks of treatment.
Time Frame
0, 2, 6, 14, 16 weeks
Title
BP、 temperature、 breath and heart rate after 5 minutes of stasis.
Time Frame
-2, 0, 2, 6, 10, 14, 16 weeks
Title
Physical examination.
Time Frame
-2, 16 weeks
Title
Adverse Events: the occurrence of melanoma.
Time Frame
0, 2, 6, 10, 14, 16 weeks
Title
Grade of UPDRS I
Time Frame
0, 6, 14, 16 weeks
Title
Blood routine、 urine routine、 ALT、 AST、 TBiL、 γ-GTP、 ALP、 BUN、 Cr、 ECG.
Time Frame
0, 6, 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gang Zhao
Organizational Affiliation
The First Affiliated Hospital of the Fourth Military Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CN002
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
CN005
City
Chenzhou
ZIP/Postal Code
423000
Country
China
Facility Name
CN007
City
Chongqing
ZIP/Postal Code
404000
Country
China
Facility Name
CN003
City
Guilin
ZIP/Postal Code
541001
Country
China
Facility Name
CN004
City
Lanzhou
ZIP/Postal Code
730050
Country
China
Facility Name
CN006
City
Luzhou
ZIP/Postal Code
646000
Country
China
Facility Name
CN008
City
Nanjing
ZIP/Postal Code
210029
Country
China
Facility Name
CN001
City
Xi'an
ZIP/Postal Code
710032
Country
China

12. IPD Sharing Statement

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

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