Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rasagiline | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rasagiline | Drug | 1 mg/day, tablets, once daily, orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline to Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline to Week 26 |
| Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part II) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other inclusion and exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CN015 | Beijing | 100034 | China | |||
| CN001 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30534374 | Derived | 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. |
Not provided
Not provided
A Screening Visit was held approximately 28 days prior to group assignment (group assignment was held during the Baseline Visit). Patients who met each of the inclusion criteria and none of the exclusion criteria were eligible to participate in this study.
Outpatients aged 35 years or older, who had idiopathic Parkinson's disease and were not treated with levodopa or other antiparkinsonian medications, were recruited for this study from China.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | placebo: tablets, once daily, orally |
| FG001 | Rasagiline | rasagiline: 1 mg/day, tablets, once daily, orally |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The all-patients-treated set (APTS) comprises all randomised patients who took at least one dose of IMP.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | placebo: tablets, once daily, orally |
| BG001 | Rasagiline | rasagiline: 1 mg/day, tablets, once daily, orally |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 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). | The full-analysis set (FAS) comprised all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the primary efficacy variable. | Posted | Mean | Standard Error | units on a scale | Baseline to Week 26 |
|
30 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | placebo: tablets, once daily, orally |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract | Eye disorders | MedDRA 16.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study director | Email contact via H. Ludbeck A/S | LundbeckClinicalTrials@lundbeck.com |
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C031967 | rasagiline |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo | Drug | tablets, once daily, orally |
|
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) |
| Baseline to Week 26 |
| 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) | Baseline to Week 26 |
| 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. | Baseline to Week 26 |
| 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. | Baseline to Week 26 |
| Beijing |
| 100730 |
| China |
| CN011 | Chengdu | 610041 | China |
| CN003 | Guangzhou | 510120 | China |
| CN005 | Guangzhou | 510180 | China |
| CN017 | Guangzhou | 510260 | China |
| CN004 | Hangzhou | 310009 | China |
| CN012 | Shanghai | 200025 | China |
| CN007 | Shanghai | 200040 | China |
| CN013 | Shanghai | 200127 | China |
| CN006 | Suzhou | 215004 | China |
| CN009 | Wuhan | 430022 | China |
| CN016 | Wuhan | 430030 | China |
| CN010 | Xi'an | 710032 | China |
| CN014 | Xi'an | 710061 | China |
| Withdrawal of Consent |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Rasagiline | rasagiline: 1 mg/day, tablets, once daily, orally |
|
|
|
| Secondary | 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) | The full-analysis set (FAS) comprised all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the primary efficacy variable. | Posted | Mean | Standard Error | units on a scale | Baseline to Week 26 |
|
|
|
|
| Secondary | 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) | The full-analysis set (FAS) comprised all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the primary efficacy variable. | Posted | Mean | Standard Error | units on a scale | Baseline to Week 26 |
|
|
|
|
| Secondary | 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) | The full-analysis set (FAS) comprised all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the primary efficacy variable. | Posted | Mean | Standard Error | units on a scale | Baseline to Week 26 |
|
|
|
|
| Secondary | 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. | Not Posted | Baseline to Week 26 |
| Secondary | 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. | Not Posted | Baseline to Week 26 |
| 4 |
| 65 |
| 6 |
| 65 |
| EG001 | Rasagiline | rasagiline: 1 mg/day, tablets, once daily, orally | 0 | 65 | 8 | 65 |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
|
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Major depression | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Parkinson's disease | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
|
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |