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

Phase 3

Completed

• Conditions: Parkinson´s Disease
• Interventions: Drug: Placebo; Drug: Rasagiline

• Registration Number: NCT01736891
• Lead Sponsor: Chongqing Fortune Pharmaceutical Co., Ltd.

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.

Study Timeline

• Study Start: 2011-11
• Status Verified: 2012-11
• Study First Submitted: 2012-11-27
• Study First Submitted QC: 2012-11-28
• Study First Posted: 2012-11-29
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Last Update Submitted: 2013-09-12
• Last Update Posted: 2013-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 268

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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)
Rasagiline	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)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Grade of UPDRS I	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
Blood routine、 urine routine、 ALT、 AST、 TBiL、 γ-GTP、 ALP、 BUN、 Cr、 ECG.	0, 6, 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

Trial Locations

Locations (8)

CN006; 🇨🇳 Luzhou, China

CN003; 🇨🇳 Guilin, China

CN002; 🇨🇳 Chengdu, China

CN007; 🇨🇳 Chongqing, China

CN005; 🇨🇳 Chenzhou, China

CN004; 🇨🇳 Lanzhou, China

CN001; 🇨🇳 Xi'an, China

CN008; 🇨🇳 Nanjing, China