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

Parkinson's Disease Clinical Trial

Official title:

Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01556165
• Other study ID #: 13485A
• Status: Completed
• Phase: Phase 3
• First received: March 13, 2012
• Last updated: December 22, 2014
• Start date: April 2012

Study information

• Verified date: December 2014
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• rasagiline
1 mg/day, tablets, once daily, orally
• placebo
tablets, once daily, orally

Locations

Country	Name	City	State
China	CN001	Beijing
China	CN015	Beijing
China	CN011	Chengdu
China	CN003	Guangzhou
China	CN005	Guangzhou
China	CN017	Guangzhou
China	CN004	Hangzhou
China	CN007	Shanghai
China	CN012	Shanghai
China	CN013	Shanghai
China	CN006	Suzhou
China	CN009	Wuhan
China	CN016	Wuhan
China	CN010	Xi'an
China	CN014	Xi'an

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Week 26 in UPDRS Total Score	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).	Baseline to Week 26	No
Secondary	Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part I)	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)	Baseline to Week 26	No
Secondary	Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part II)	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)	Baseline to Week 26	No
Secondary	Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part III)	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)	Baseline to Week 26	No
Secondary	Time to Onset of Levodopa Therapy	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.	Baseline to Week 26	No
Secondary	Levodopa Administration Within 26 Weeks	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.	Baseline to Week 26	No