Clinical Trial of Rasagiline in Levodopa-Treated Parkinson's Disease Patients With Motor Fluctuations

Sponsor

Chongqing Fortune Pharmaceutical Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT01736891

Collaborator

Beijing Bionovo Medicine Development Co., Ltd. (Other)

268

Enrollment

Locations

Arms

Duration (Months)

33.5

Patients Per Site

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson´s Disease	Drug: Rasagiline Drug: Placebo	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

268 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Evaluation for the Efficacy,Tolerability,and Safety of Rasagiline in Levodopa-treated PD Patients With Motor Fluctuations: A Multicenter, Double Blind, Randomized, Placebo-Controlled Group Study (China)

Study Start Date :

Nov 1, 2011

Actual Primary Completion Date :

Jun 1, 2013

Actual Study Completion Date :

Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rasagiline 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)	Drug: Rasagiline Tablets, qd Other Names: Azilect
Placebo Comparator: Placebo 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)	Drug: Placebo Tablets, qd

Arm

Intervention/Treatment

Experimental: Rasagiline

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)

Drug: Rasagiline

Tablets, qd

Other Names:

Azilect

Placebo Comparator: Placebo

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)

Drug: Placebo

Tablets, qd

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CN002	Chengdu	China	610041
2	CN005	Chenzhou	China	423000
3	CN007	Chongqing	China	404000
4	CN003	Guilin	China	541001
5	CN004	Lanzhou	China	730050
6	CN006	Luzhou	China	646000
7	CN008	Nanjing	China	210029
8	CN001	Xi'an	China	710032