Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa in China

Phase 3

Completed

Conditions: Parkinson's Disease

Interventions: Drug: placebo
Drug: rasagiline

Registration Number: NCT01556165

Lead Sponsor: H. Lundbeck A/S

Brief Summary: Rasagiline has been developed for the treatment of Parkinson's Disease (PD), as monotherapy in early PD patients not treated with levodopa, and as adjunct therapy to levodopa in levodopa-treated PD patients with motor fluctuations.

The rationale for conducting this study is to evaluate the efficacy, tolerability, and safety of rasagiline compared to placebo in Chinese PD patients not treated with levodopa.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 130

Inclusion Criteria

Patients with idiopathic PD.
Patients with a Modified Hoehn and Yahr stage <3.

Exclusion Criteria

Patients with a clinically significant or unstable medical or surgical condition that would preclude his/her safe and complete study participation.
Patients with a clinically significant or unstable vascular disease.
Patients with a clinically significant psychiatric illness, including a major depression, which compromises their ability to provide consent or participate fully in the study.
Patients with a Mini Mental State Examination (MMSE) score ≤24.
Patients with a diagnosis of melanoma or a history of melanoma, or a suspicious lesion.

Other inclusion and exclusion criteria may apply.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	-
rasagiline	rasagiline	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Week 26 in UPDRS Total Score	Baseline to Week 26	The Unified Parkinson's Disease Rating Scale (UPDRS) is a 42-item rating scale designed to assess Parkinson's disease-related disability and impairment. The scale comprises four parts: Part I evaluates mentation, behaviour, and mood symptoms; Part II evaluates activities of daily living (ADL); Part III evaluates motor function; and Part IV evaluates complications of dopaminergic therapy. The total score is the sum of the subscale scores for Parts I to III and ranges from 0 (no disability) to 176 (total dependence).

Secondary Outcome Measures

Name	Time	Method
Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part III)	Baseline to Week 26	The Unified Parkinson's Disease Rating Scale (UPDRS) Part III evaluates motor function, it comprises 14 parts and the score ranges from 0 (normal) to 108 (severe impairement and disability)
Time to Onset of Levodopa Therapy	Baseline to Week 26	It was stated in the statistical analysis plan (SAP) that if \>10% of FAS patients were considered to have taken levodopa during the treatment period, the endpoint, time to onset of levodopa treatment was to be analysed. However, since only one patient (in the placebo group) had levodopa administered during the treatment period, this endpoint was not analysed, as had been defined a priori in the SAP.
Levodopa Administration Within 26 Weeks	Baseline to Week 26	It was stated in the statistical analysis plan (SAP) that if \>10% of FAS patients were considered to have taken levodopa during the treatment period, the endpoint, levodopa administration within 26 Weeks was to be analysed. However, since only one patient (in the placebo group) had levodopa administered during the treatment period, this endpoint was not analysed, as had been defined a priori in the SAP.
Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part I)	Baseline to Week 26	The Unified Parkinson's Disease Rating Scale (UPDRS) Part I evaluates mentation, behaviour and mood symptoms, it comprises 4 parts and the score ranges from 0 (normal) to 16 (severe impairement)
Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part II)	Baseline to Week 26	The Unified Parkinson's Disease Rating Scale (UPDRS) Part II evaluates activities of daily living, it comprises 13 parts and the score ranges from 0 (normal) to 52 (severe impairement and disability)

Trial Locations

Locations (15): CN005
🇨🇳
Guangzhou, China
CN011
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Chengdu, China
CN004
🇨🇳
Hangzhou, China
CN003
🇨🇳
Guangzhou, China
CN016
🇨🇳
Wuhan, China
CN014
🇨🇳
Xi'an, China
CN015
🇨🇳
Beijing, China
CN001
🇨🇳
Beijing, China
CN010
🇨🇳
Xi'an, China
CN012
🇨🇳
Shanghai, China
CN007
🇨🇳
Shanghai, China
CN017
🇨🇳
Guangzhou, China
CN006
🇨🇳
Suzhou, China
CN009
🇨🇳
Wuhan, China
CN013
🇨🇳
Shanghai, China