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The rationale for conducting this study is to evaluate the efficacy, tolerability, and safety of rasagiline compared to placebo in levodopa-treated Parkinson's Disease (PD) Chinese patients with motor fluctuations. Azilect® (Rasagiline) is indicated for the treatment of idiopathic PD as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Azilect® | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Once daily; tablet; orally; 16 weeks |
| |
| Azilect® |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Total Daily OFF Time Using Parkinson's Disease Patient Diary | 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. | Baseline and Weeks 4, 8, 12, and 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Status Using CGI-I Score During ON Time | 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). | Week 16 |
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Inclusion Criteria:
Exclusion Criteria:
Other inclusion and exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CN015 | Beijing | 100034 | China | |||
| CN008 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29988514 | Derived | Zhang Z, Shao M, Chen S, Liu C, Peng R, Li Y, Wang J, Zhu S, Qu Q, Zhang X, Chen H, Sun X, Wang Y, Sun S, Zhang B, Li J, Pan X, Zhao G. Adjunct rasagiline to treat Parkinson's disease with motor fluctuations: a randomized, double-blind study in China. Transl Neurodegener. 2018 Jun 30;7:14. doi: 10.1186/s40035-018-0119-7. eCollection 2018. |
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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.
Outpatients with a primary diagnosis of idiopathic Parkinson's disease.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Once daily; tablet; orally; 16 weeks |
| FG001 | Azilect® | 1 mg daily; tablet; orally; 16 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Once daily; tablet; orally; 16 weeks |
| BG001 | Azilect® | 1 mg daily; tablet; orally; 16 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | all-patients-treated set (APTS) - all patients in the all-patients-randomised set (APRS) who took at least one dose of investigational medicinal product (IMP). |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Mean Total Daily OFF Time Using Parkinson's Disease Patient Diary | 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. | Full-analysis set (FAS); observed cases (OC) | Posted | Mean | Standard Error | hours | Baseline and Weeks 4, 8, 12, and 16 |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Once daily; tablet; orally; 16 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sick Sinus Syndrome | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyskinesia | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| H. Lundbeck A/S | H. Lundbeck A/S | +45 3630 1311 | LundbeckClinicalTrials@lundbeck.com |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C031967 | rasagiline |
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| Drug |
1 mg daily; tablet; orally; 16 weeks |
|
|
| Change From Baseline in UPDRS-ADL Score During OFF Time | 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). | Baseline and Week 16 |
| Change From Baseline in UPDRS Motor Score During ON Time | 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). | Baseline and Week 16 |
| Beijing |
| 100050 |
| China |
| CN017 | Beijing | 100050 | China |
| CN001 | Beijing | 100730 | China |
| CN018 | Beijing | 100730 | China |
| CN011 | Chengdu | 610041 | China |
| CN003 | Guangzhou | 510120 | China |
| CN005 | Guangzhou | 510180 | China |
| CN004 | Hangzhou | 310009 | China |
| CN019 | Qingyu Zhou | 510260 | China |
| CN020 | Qingyu Zhou | 510260 | China |
| CN012 | Shanghai | 200025 | China |
| CN007 | Shanghai | 200040 | China |
| CN013 | Shanghai | 200127 | China |
| CN006 | Suzhou | 215004 | China |
| CN009 | Wuhan | 430022 | China |
| CN010 | Xi'an | 710032 | China |
| CN014 | Zi’an | 710061 | China |
| Protocol Violation |
|
| Withdrawal of Consent |
|
| BG002 |
| Total |
Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | APTS | Count of Participants | Participants |
|
| Total Daily OFF Time | 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. Full-analysis set (FAS) - all patients in the APTS who had at least one valid post-baseline measurement of the total daily OFF time (a valid post-baseline diary was a diary reported from Week 4 onwards based on pre-defined visit windows). | Mean | Standard Deviation | hours |
|
| CGI-S | Clinical Global Impression - Severity of Illness (CGI-S) is a single-item rating scale used to evaluate a patient's severity of illness on a 7-point scale, based on the investigator's total clinical experience with patients. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). FAS. | Mean | Standard Deviation | units on a scale |
|
| UPDRS-ADL Score During OFF Time | Unified Parkinson's Disease Rating Scale (UPDRS) is a 42-item rating scale designed to assess PD-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). FAS. | Mean | Standard Deviation | units on a scale |
|
| UPDRS Motor Score During ON time | UPDRS is a 42-item rating scale designed to assess PD-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). FAS. | Mean | Standard Deviation | units on a scale |
|
| OG001 |
| Azilect® |
1 mg daily; tablet; orally; 16 weeks |
|
|
|
| Secondary | Clinical Status Using CGI-I Score During ON Time | 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). | FAS; last observation carried forward (LOCF) | Posted | Mean | Standard Error | units on a scale | Week 16 |
|
|
|
|
| Secondary | Change From Baseline in UPDRS-ADL Score During OFF Time | 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). | FAS; LOCF | Posted | Mean | Standard Error | units on a scale | Baseline and Week 16 |
|
|
|
|
| Secondary | Change From Baseline in UPDRS Motor Score During ON Time | 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). | FAS; LOCF | Posted | Mean | Standard Error | units on a scale | Baseline and Week 16 |
|
|
|
|
| 5 |
| 158 |
| 12 |
| 158 |
| EG001 | Azilect® | 1 mg daily; tablet; orally; 16 weeks | 7 | 163 | 11 | 163 |
| Oedema Peripheral | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Multiple Fractures | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Peripheral Nerve Injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Parkinson's Disease | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Transient Ischaemic Attack | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Delusional Perception | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Venous Stenosis | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
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.
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |