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

NCT ID: NCT01736891

Last Updated: 2013-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

268 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Parkinson´s Disease

Keywords

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Motor fluctuations Parkinson´s Disease Rasagiline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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)

Group Type EXPERIMENTAL

Rasagiline

Intervention Type DRUG

Tablets, qd

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)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tablets, qd

Interventions

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Rasagiline

Tablets, qd

Intervention Type DRUG

Placebo

Tablets, qd

Intervention Type DRUG

Other Intervention Names

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Azilect

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Bionovo Medicine Development Co., Ltd.

OTHER

Sponsor Role collaborator

Chongqing Fortune Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gang Zhao

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of the Fourth Military Medical University

Locations

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CN002

Chengdu, , China

Site Status

CN005

Chenzhou, , China

Site Status

CN007

Chongqing, , China

Site Status

CN003

Guilin, , China

Site Status

CN004

Lanzhou, , China

Site Status

CN006

Luzhou, , China

Site Status

CN008

Nanjing, , China

Site Status

CN001

Xi'an, , China

Site Status

Countries

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China

Other Identifiers

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RLPDMF2010L03416

Identifier Type: -

Identifier Source: org_study_id