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

Parkinson´s Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01736891
• Other study ID #: RLPDMF2010L03416
• Status: Completed
• Phase: Phase 3
• First received: November 27, 2012
• Last updated: September 12, 2013
• Start date: November 2011
• Est. completion date: June 2013

Study information

• Verified date: November 2012
• Source: Chongqing Fortune Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 268
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson´s Disease

Intervention

Drug:
• Rasagiline
Tablets, qd
• Placebo
Tablets, qd

Locations

Country	Name	City	State
China	CN002	Chengdu
China	CN005	Chenzhou
China	CN007	Chongqing
China	CN003	Guilin
China	CN004	Lanzhou
China	CN006	Luzhou
China	CN008	Nanjing
China	CN001	Xi'an

Sponsors (2)

Lead Sponsor	Collaborator
Chongqing Fortune Pharmaceutical Co., Ltd.	Beijing Bionovo Medicine Development Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change from baseline to week 6/10/16 in mean total daily OFF time measured by patients' home diaries.		0, 6, 10, 16 weeks	No
Secondary	Change from baseline to week 6/14/16 in mean total daily ON time measured by patients' home diaries.		0, 6, 14, 16 weeks	No
Secondary	Change from baseline to week 6/14/16 on Unified Parkinson's Disease Rating Scale (UPDRS) ?- ? Activities of Daily Living.		0, 6, 14, 16 weeks	No
Secondary	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	No
Secondary	Analysis of the changing rate of the UPDRS? -? after treatment of week 6/14/16.		0, 6, 14, 16 weeks	No
Secondary	The rate of patients whose Levodopa dose is adjusted after 6/14/16 weeks of treatment.		0, 2, 6, 14, 16 weeks	No
Secondary	BP? temperature? breath and heart rate after 5 minutes of stasis.		-2, 0, 2, 6, 10, 14, 16 weeks	Yes
Secondary	Physical examination.		-2, 16 weeks	Yes
Secondary	Adverse Events: the occurrence of melanoma.		0, 2, 6, 10, 14, 16 weeks	Yes
Secondary	Grade of UPDRS I		0, 6, 14, 16 weeks	Yes
Secondary	Blood routine? urine routine? ALT? AST? TBiL? ?-GTP? ALP? BUN? Cr? ECG.		0, 6, 16 weeks	Yes