Back to resultsRasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa in China
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
rasagiline
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Rasagiline, Azilect, Parkinson´s Disease, Motor fluctuations
Eligibility Criteria
Inclusion Criteria:
- Patients with idiopathic PD.
- Patients with a Modified Hoehn and Yahr stage <3.
Exclusion Criteria:
- Patients with a clinically significant or unstable medical or surgical condition that would preclude his/her safe and complete study participation.
- Patients with a clinically significant or unstable vascular disease.
- Patients with a clinically significant psychiatric illness, including a major depression, which compromises their ability to provide consent or participate fully in the study.
- Patients with a Mini Mental State Examination (MMSE) score ≤24.
- Patients with a diagnosis of melanoma or a history of melanoma, or a suspicious lesion.
Other inclusion and exclusion criteria may apply.
Sites / Locations
- CN015
- CN001
- CN011
- CN003
- CN005
- CN017
- CN004
- CN012
- CN007
- CN013
- CN006
- CN009
- CN016
- CN010
- CN014
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
rasagiline
placebo
Arm Description
Outcomes
Primary Outcome Measures
Change From Baseline to Week 26 in UPDRS Total Score
The Unified Parkinson's Disease Rating Scale (UPDRS) is a 42-item rating scale designed to assess Parkinson's disease-related disability and impairment. The scale comprises four parts: Part I evaluates mentation, behaviour, and mood symptoms; Part II evaluates activities of daily living (ADL); Part III evaluates motor function; and Part IV evaluates complications of dopaminergic therapy. The total score is the sum of the subscale scores for Parts I to III and ranges from 0 (no disability) to 176 (total dependence).
Secondary Outcome Measures
Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part I)
The Unified Parkinson's Disease Rating Scale (UPDRS) Part I evaluates mentation, behaviour and mood symptoms, it comprises 4 parts and the score ranges from 0 (normal) to 16 (severe impairement)
Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part II)
The Unified Parkinson's Disease Rating Scale (UPDRS) Part II evaluates activities of daily living, it comprises 13 parts and the score ranges from 0 (normal) to 52 (severe impairement and disability)
Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part III)
The Unified Parkinson's Disease Rating Scale (UPDRS) Part III evaluates motor function, it comprises 14 parts and the score ranges from 0 (normal) to 108 (severe impairement and disability)
Time to Onset of Levodopa Therapy
It was stated in the statistical analysis plan (SAP) that if >10% of FAS patients were considered to have taken levodopa during the treatment period, the endpoint, time to onset of levodopa treatment was to be analysed. However, since only one patient (in the placebo group) had levodopa administered during the treatment period, this endpoint was not analysed, as had been defined a priori in the SAP.
Levodopa Administration Within 26 Weeks
It was stated in the statistical analysis plan (SAP) that if >10% of FAS patients were considered to have taken levodopa during the treatment period, the endpoint, levodopa administration within 26 Weeks was to be analysed. However, since only one patient (in the placebo group) had levodopa administered during the treatment period, this endpoint was not analysed, as had been defined a priori in the SAP.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01556165
Brief Title
Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa in China
Official Title
Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa in China
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Rasagiline has been developed for the treatment of Parkinson's Disease (PD), as monotherapy in early PD patients not treated with levodopa, and as adjunct therapy to levodopa in levodopa-treated PD patients with motor fluctuations.
The rationale for conducting this study is to evaluate the efficacy, tolerability, and safety of rasagiline compared to placebo in Chinese PD patients not treated with levodopa.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Rasagiline, Azilect, Parkinson´s Disease, Motor fluctuations
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rasagiline
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
rasagiline
Other Intervention Name(s)
Azilect
Intervention Description
1 mg/day, tablets, once daily, orally
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
tablets, once daily, orally
Primary Outcome Measure Information:
Title
Change From Baseline to Week 26 in UPDRS Total Score
Description
The Unified Parkinson's Disease Rating Scale (UPDRS) is a 42-item rating scale designed to assess Parkinson's disease-related disability and impairment. The scale comprises four parts: Part I evaluates mentation, behaviour, and mood symptoms; Part II evaluates activities of daily living (ADL); Part III evaluates motor function; and Part IV evaluates complications of dopaminergic therapy. The total score is the sum of the subscale scores for Parts I to III and ranges from 0 (no disability) to 176 (total dependence).
Time Frame
Baseline to Week 26
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part I)
Description
The Unified Parkinson's Disease Rating Scale (UPDRS) Part I evaluates mentation, behaviour and mood symptoms, it comprises 4 parts and the score ranges from 0 (normal) to 16 (severe impairement)
Time Frame
Baseline to Week 26
Title
Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part II)
Description
The Unified Parkinson's Disease Rating Scale (UPDRS) Part II evaluates activities of daily living, it comprises 13 parts and the score ranges from 0 (normal) to 52 (severe impairement and disability)
Time Frame
Baseline to Week 26
Title
Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part III)
Description
The Unified Parkinson's Disease Rating Scale (UPDRS) Part III evaluates motor function, it comprises 14 parts and the score ranges from 0 (normal) to 108 (severe impairement and disability)
Time Frame
Baseline to Week 26
Title
Time to Onset of Levodopa Therapy
Description
It was stated in the statistical analysis plan (SAP) that if >10% of FAS patients were considered to have taken levodopa during the treatment period, the endpoint, time to onset of levodopa treatment was to be analysed. However, since only one patient (in the placebo group) had levodopa administered during the treatment period, this endpoint was not analysed, as had been defined a priori in the SAP.
Time Frame
Baseline to Week 26
Title
Levodopa Administration Within 26 Weeks
Description
It was stated in the statistical analysis plan (SAP) that if >10% of FAS patients were considered to have taken levodopa during the treatment period, the endpoint, levodopa administration within 26 Weeks was to be analysed. However, since only one patient (in the placebo group) had levodopa administered during the treatment period, this endpoint was not analysed, as had been defined a priori in the SAP.
Time Frame
Baseline to Week 26
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with idiopathic PD.
Patients with a Modified Hoehn and Yahr stage <3.
Exclusion Criteria:
Patients with a clinically significant or unstable medical or surgical condition that would preclude his/her safe and complete study participation.
Patients with a clinically significant or unstable vascular disease.
Patients with a clinically significant psychiatric illness, including a major depression, which compromises their ability to provide consent or participate fully in the study.
Patients with a Mini Mental State Examination (MMSE) score ≤24.
Patients with a diagnosis of melanoma or a history of melanoma, or a suspicious lesion.
Other inclusion and exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@lundbeck.com
Official's Role
Principal Investigator
Facility Information:
Facility Name
CN015
City
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
CN001
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
CN011
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
CN003
City
Guangzhou
ZIP/Postal Code
510120
Country
China
Facility Name
CN005
City
Guangzhou
ZIP/Postal Code
510180
Country
China
Facility Name
CN017
City
Guangzhou
ZIP/Postal Code
510260
Country
China
Facility Name
CN004
City
Hangzhou
ZIP/Postal Code
310009
Country
China
Facility Name
CN012
City
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
CN007
City
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
CN013
City
Shanghai
ZIP/Postal Code
200127
Country
China
Facility Name
CN006
City
Suzhou
ZIP/Postal Code
215004
Country
China
Facility Name
CN009
City
Wuhan
ZIP/Postal Code
430022
Country
China
Facility Name
CN016
City
Wuhan
ZIP/Postal Code
430030
Country
China
Facility Name
CN010
City
Xi'an
ZIP/Postal Code
710032
Country
China
Facility Name
CN014
City
Xi'an
ZIP/Postal Code
710061
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
30534374
Citation
Zhang Z, Wang J, Chen S, Liu C, Zhang B, Peng R, Sun S, Sun X, Zhao G, Qu Q, Li Y, Zhu S, Pan X, Shao M, Wang Y. Efficacy and safety of rasagiline in Chinese patients with early Parkinson's disease: a randomized, double-blind, parallel, placebo-controlled, fixed-dose study. Transl Neurodegener. 2018 Dec 6;7:32. doi: 10.1186/s40035-018-0137-5. eCollection 2018.
Results Reference
derived
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Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa in China
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