Trial Outcomes & Findings for Azilect® (Rasagiline) in Levodopa-treated Parkinson's Patients With Motor Fluctuations in China (NCT NCT01479530)
NCT ID: NCT01479530
Last Updated: 2018-09-10
Results Overview
Parkinson's Disease Patient Diary is a self-administered diary designed to assess motor fluctuations throughout the day. It is divided into 30-minute intervals, and the patient selects one of four options for each interval: asleep; off; on with no dyskinesia or without troublesome dyskinesia; or on with troublesome dyskinesia. The Change From Baseline in Mean Total Daily OFF time is calculated by taking the difference between the average of the total daily OFF time at Weeks 4, 8, 12, and 16, and the Baseline Total Daily OFF Time.
COMPLETED
PHASE3
321 participants
Baseline and Weeks 4, 8, 12, and 16
2018-09-10
Participant Flow
Outpatients with a primary diagnosis of idiopathic Parkinson's disease.
The study consisted of a 2-week Screening Period during which the levodopa dose was optimised (if required), a 2-week Screening Period during which the levodopa dose was stabilised, a 16-week double-blind treatment period with rasagiline or placebo once daily (patients were randomised in a 1:1 ratio), and a 4-week Safety Follow-up Period.
Participant milestones
| Measure |
Placebo
Once daily; tablet; orally; 16 weeks
|
Azilect®
1 mg daily; tablet; orally; 16 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
158
|
163
|
|
Overall Study
COMPLETED
|
148
|
151
|
|
Overall Study
NOT COMPLETED
|
10
|
12
|
Reasons for withdrawal
| Measure |
Placebo
Once daily; tablet; orally; 16 weeks
|
Azilect®
1 mg daily; tablet; orally; 16 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
6
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Protocol Violation
|
2
|
3
|
|
Overall Study
Withdrawal of Consent
|
3
|
2
|
Baseline Characteristics
Azilect® (Rasagiline) in Levodopa-treated Parkinson's Patients With Motor Fluctuations in China
Baseline characteristics by cohort
| Measure |
Placebo
n=158 Participants
Once daily; tablet; orally; 16 weeks
|
Azilect®
n=163 Participants
1 mg daily; tablet; orally; 16 weeks
|
Total
n=321 Participants
Total of all reporting groups
|
|---|---|---|---|
|
CGI-S
|
4.07 units on a scale
STANDARD_DEVIATION 0.77 • n=5 Participants
|
3.94 units on a scale
STANDARD_DEVIATION 0.76 • n=7 Participants
|
4.00 units on a scale
STANDARD_DEVIATION 0.77 • n=5 Participants
|
|
Age, Continuous
|
61.7 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
62.7 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
62.2 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
109 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
212 Participants
n=5 Participants
|
|
Total Daily OFF Time
|
6.13 hours
STANDARD_DEVIATION 2.72 • n=5 Participants
|
6.10 hours
STANDARD_DEVIATION 2.60 • n=7 Participants
|
6.12 hours
STANDARD_DEVIATION 2.66 • n=5 Participants
|
|
UPDRS-ADL Score During OFF Time
|
16.45 units on a scale
STANDARD_DEVIATION 7.54 • n=5 Participants
|
15.59 units on a scale
STANDARD_DEVIATION 7.15 • n=7 Participants
|
16.01 units on a scale
STANDARD_DEVIATION 7.34 • n=5 Participants
|
|
UPDRS Motor Score During ON time
|
25.62 units on a scale
STANDARD_DEVIATION 10.48 • n=5 Participants
|
23.82 units on a scale
STANDARD_DEVIATION 10.47 • n=7 Participants
|
24.70 units on a scale
STANDARD_DEVIATION 10.50 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Weeks 4, 8, 12, and 16Population: Full-analysis set (FAS); observed cases (OC)
Parkinson's Disease Patient Diary is a self-administered diary designed to assess motor fluctuations throughout the day. It is divided into 30-minute intervals, and the patient selects one of four options for each interval: asleep; off; on with no dyskinesia or without troublesome dyskinesia; or on with troublesome dyskinesia. The Change From Baseline in Mean Total Daily OFF time is calculated by taking the difference between the average of the total daily OFF time at Weeks 4, 8, 12, and 16, and the Baseline Total Daily OFF Time.
Outcome measures
| Measure |
Placebo
n=150 Participants
Once daily; tablet; orally; 16 weeks
|
Azilect®
n=158 Participants
1 mg daily; tablet; orally; 16 weeks
|
|---|---|---|
|
Change From Baseline in Mean Total Daily OFF Time Using Parkinson's Disease Patient Diary
|
-0.76 hours
Standard Error 0.16
|
-1.25 hours
Standard Error 0.16
|
SECONDARY outcome
Timeframe: Week 16Population: FAS; last observation carried forward (LOCF)
Clinical Global Impression - Global Improvement (CGI-I) is a single-item rating scale used to evaluate a patient's condition relative to baseline on a 7-point scale, regardless of whether the improvement is related to the investigational medicinal product (IMP). The scale ranges from 1 (very much improved) to 7 (very much worse).
Outcome measures
| Measure |
Placebo
n=151 Participants
Once daily; tablet; orally; 16 weeks
|
Azilect®
n=157 Participants
1 mg daily; tablet; orally; 16 weeks
|
|---|---|---|
|
Clinical Status Using CGI-I Score During ON Time
|
3.56 units on a scale
Standard Error 0.07
|
3.15 units on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: FAS; LOCF
Unified Parkinson's Disease Rating Scale (UPDRS) is a 42-item rating scale designed to assess Parkinson's Disease-related disability and impairment using a patient interview and a physical examination. It has 4 parts and 4 subsection scores. A higher score indicates a worse outcome. I: mentation, behaviour and mood symptoms - 0 to 16; II: activities of daily living (ADL) - 0 to 52; III: motor function - 0 to 108; IV: complications of dopaminergic therapy - 0 to 23. Subsection scores for I to III are used to calculate a total score that ranges from 0 (no disability) to 176 (total dependence).
Outcome measures
| Measure |
Placebo
n=152 Participants
Once daily; tablet; orally; 16 weeks
|
Azilect®
n=158 Participants
1 mg daily; tablet; orally; 16 weeks
|
|---|---|---|
|
Change From Baseline in UPDRS-ADL Score During OFF Time
|
-1.20 units on a scale
Standard Error 0.28
|
-2.21 units on a scale
Standard Error 0.28
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: FAS; LOCF
UPDRS is a 42-item rating scale designed to assess Parkinson's Disease-related disability and impairment using a patient interview and a physical examination. It has 4 parts and 4 subsection scores. A higher score indicates a worse outcome. I: mentation, behaviour and mood symptoms - 0 to 16; II: ADL - 0 to 52; III: motor function - 0 to 108; IV: complications of dopaminergic therapy - 0 to 23. Subsection scores for I to III are used to calculate a total score that ranges from 0 (no disability) to 176 (total dependence).
Outcome measures
| Measure |
Placebo
n=152 Participants
Once daily; tablet; orally; 16 weeks
|
Azilect®
n=158 Participants
1 mg daily; tablet; orally; 16 weeks
|
|---|---|---|
|
Change From Baseline in UPDRS Motor Score During ON Time
|
-1.75 units on a scale
Standard Error 0.55
|
-3.34 units on a scale
Standard Error 0.55
|
Adverse Events
Placebo
Azilect®
Serious adverse events
| Measure |
Placebo
n=158 participants at risk
Once daily; tablet; orally; 16 weeks
|
Azilect®
n=163 participants at risk
1 mg daily; tablet; orally; 16 weeks
|
|---|---|---|
|
Cardiac disorders
Sick Sinus Syndrome
|
0.00%
0/158 • Serious Adverse Events: 16-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 16-week double-blind treatment period.
|
0.61%
1/163 • Serious Adverse Events: 16-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 16-week double-blind treatment period.
|
|
General disorders
Oedema Peripheral
|
0.63%
1/158 • Serious Adverse Events: 16-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 16-week double-blind treatment period.
|
0.00%
0/163 • Serious Adverse Events: 16-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 16-week double-blind treatment period.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/158 • Serious Adverse Events: 16-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 16-week double-blind treatment period.
|
0.61%
1/163 • Serious Adverse Events: 16-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 16-week double-blind treatment period.
|
|
Infections and infestations
Erysipelas
|
0.63%
1/158 • Serious Adverse Events: 16-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 16-week double-blind treatment period.
|
0.00%
0/163 • Serious Adverse Events: 16-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 16-week double-blind treatment period.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.63%
1/158 • Serious Adverse Events: 16-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 16-week double-blind treatment period.
|
0.00%
0/163 • Serious Adverse Events: 16-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 16-week double-blind treatment period.
|
|
Injury, poisoning and procedural complications
Multiple Fractures
|
0.63%
1/158 • Serious Adverse Events: 16-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 16-week double-blind treatment period.
|
0.00%
0/163 • Serious Adverse Events: 16-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 16-week double-blind treatment period.
|
|
Injury, poisoning and procedural complications
Peripheral Nerve Injury
|
0.00%
0/158 • Serious Adverse Events: 16-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 16-week double-blind treatment period.
|
0.61%
1/163 • Serious Adverse Events: 16-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 16-week double-blind treatment period.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.63%
1/158 • Serious Adverse Events: 16-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 16-week double-blind treatment period.
|
0.00%
0/163 • Serious Adverse Events: 16-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 16-week double-blind treatment period.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.63%
1/158 • Serious Adverse Events: 16-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 16-week double-blind treatment period.
|
0.00%
0/163 • Serious Adverse Events: 16-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 16-week double-blind treatment period.
|
|
Nervous system disorders
Parkinson's Disease
|
0.00%
0/158 • Serious Adverse Events: 16-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 16-week double-blind treatment period.
|
0.61%
1/163 • Serious Adverse Events: 16-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 16-week double-blind treatment period.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/158 • Serious Adverse Events: 16-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 16-week double-blind treatment period.
|
0.61%
1/163 • Serious Adverse Events: 16-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 16-week double-blind treatment period.
|
|
Psychiatric disorders
Delusional Perception
|
0.00%
0/158 • Serious Adverse Events: 16-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 16-week double-blind treatment period.
|
0.61%
1/163 • Serious Adverse Events: 16-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 16-week double-blind treatment period.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.63%
1/158 • Serious Adverse Events: 16-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 16-week double-blind treatment period.
|
0.00%
0/163 • Serious Adverse Events: 16-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 16-week double-blind treatment period.
|
|
Vascular disorders
Venous Stenosis
|
0.00%
0/158 • Serious Adverse Events: 16-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 16-week double-blind treatment period.
|
0.61%
1/163 • Serious Adverse Events: 16-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 16-week double-blind treatment period.
|
Other adverse events
| Measure |
Placebo
n=158 participants at risk
Once daily; tablet; orally; 16 weeks
|
Azilect®
n=163 participants at risk
1 mg daily; tablet; orally; 16 weeks
|
|---|---|---|
|
Nervous system disorders
Dyskinesia
|
7.6%
12/158 • Serious Adverse Events: 16-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 16-week double-blind treatment period.
|
6.7%
11/163 • Serious Adverse Events: 16-week double-blind treatment period and 4-week safety follow-up period. Other Adverse Events: 16-week double-blind treatment period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The results of this study will be published. Authors of the primary publication based on this study must fulfil the criteria defined by the International Committee of Medical Journal Editors (ICMJE). The primary publication must be published before any secondary publications are submitted for publication.
- Publication restrictions are in place
Restriction type: OTHER