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| Name | Class |
|---|---|
| Beijing Bionovo Medicine Development Co., Ltd. | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rasagiline | Experimental | 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 | Placebo Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rasagiline | Drug | Tablets, qd |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0, 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to week 6/10/16 in mean total daily OFF time measured by patients' home diaries. | 0, 6, 10, 16 weeks | |
| Change from baseline to week 6/14/16 in mean total daily ON time measured by patients' home diaries. | 0, 6, 14, 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gang Zhao | The First Affiliated Hospital of the Fourth Military Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CN002 | Chengdu | 610041 | China | |||
| CN005 |
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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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| Placebo |
| Drug |
Tablets, qd |
|
| Change from baseline to week 6/14/16 on Unified Parkinson's Disease Rating Scale (UPDRS) Ⅱ- Ⅵ Activities of Daily Living. | 0, 6, 14, 16 weeks |
| Change from baseline to week 6/10/14/16 in mean total daily ON time measured by patients' home diaries. | 0, 6, 10, 14, 16 weeks |
| Analysis of the changing rate of the UPDRSⅡ -Ⅵ after treatment of week 6/14/16. | 0, 6, 14, 16 weeks |
| The rate of patients whose Levodopa dose is adjusted after 6/14/16 weeks of treatment. | 0, 2, 6, 14, 16 weeks |
| BP、 temperature、 breath and heart rate after 5 minutes of stasis. | -2, 0, 2, 6, 10, 14, 16 weeks |
| Physical examination. | -2, 16 weeks |
| Adverse Events: the occurrence of melanoma. | 0, 2, 6, 10, 14, 16 weeks |
| Grade of UPDRS I | 0, 6, 14, 16 weeks |
| Blood routine、 urine routine、 ALT、 AST、 TBiL、 γ-GTP、 ALP、 BUN、 Cr、 ECG. | 0, 6, 16 weeks |
| Chenzhou |
| 423000 |
| China |
| CN007 | Chongqing | 404000 | China |
| CN003 | Guilin | 541001 | China |
| CN004 | Lanzhou | 730050 | China |
| CN006 | Luzhou | 646000 | China |
| CN008 | Nanjing | 210029 | China |
| CN001 | Xi'an | 710032 | China |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |