Parkinson´s Disease
Conditions
Keywords
Motor fluctuations, Parkinson´s Disease, Rasagiline
Brief summary
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.
Detailed description
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.
Interventions
DRUGRasagiline
Tablets, qd
DRUGPlacebo
Tablets, qd
Sponsors
Beijing Bionovo Medicine Development Co., Ltd.
Chongqing Fortune Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with idiopathic PD * Patients receiving at least 300 mg daily doses of levodopa and not less than 8 daily doses of levodopa with the stable dose * Patient with a Modified Hoehn and Yahr stage between 2 to 4 in the OFF state * Patient with motor fluctuations averaging at least 2 hour daily in the OFF state * Patients who have demonstrated the ability to keep accurate 24-hour diaries
Exclusion criteria
* Patients with Parkinsonian syndrome induced by medicine, metabolic disease, Encephalitis and central nervous system degenerative diseases or Disease of basal ganglia * Patients with severe cognitive impairment judged by a Mini Mental State Examination * Patients with a clinically significant psychiatric illness * Patients with Hamilton Depression Rating Scale (HAMD): total score ≤10 * Patients with a clinically significant or unstable medical or surgical condition which would preclude safe and complete study participation * Patients with a clinically significant or unstable vascular disease * Patients with severe disabling dyskinesias Other inclusion and
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 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 |
| Change from baseline to week 6/14/16 in mean total daily ON time measured by patients' home diaries. | 0, 6, 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 |
| BP、 temperature、 breath and heart rate after 5 minutes of stasis. | -2, 0, 2, 6, 10, 14, 16 weeks |
Countries
China
Outcome results
None listed