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

December 22, 2014 updated by: H. Lundbeck A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100034
        • CN015
      • Beijing, China, 100730
        • CN001
      • Chengdu, China, 610041
        • CN011
      • Guangzhou, China, 510120
        • CN003
      • Guangzhou, China, 510180
        • CN005
      • Guangzhou, China, 510260
        • CN017
      • Hangzhou, China, 310009
        • CN004
      • Shanghai, China, 200025
        • CN012
      • Shanghai, China, 200040
        • CN007
      • Shanghai, China, 200127
        • CN013
      • Suzhou, China, 215004
        • CN006
      • Wuhan, China, 430022
        • CN009
      • Wuhan, China, 430030
        • CN016
      • Xi'an, China, 710032
        • CN010
      • Xi'an, China, 710061
        • CN014

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: placebo
Drug: placebo
tablets, once daily, orally
EXPERIMENTAL: rasagiline
Drug: rasagiline
1 mg/day, tablets, once daily, orally
Other Names:
  • Azilect

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 26 in UPDRS Total Score
Time Frame: 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).
Baseline to Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part I)
Time Frame: 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)
Baseline to Week 26
Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part II)
Time Frame: 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)
Baseline to Week 26
Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part III)
Time Frame: 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)
Baseline to Week 26
Time to Onset of Levodopa Therapy
Time Frame: 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.
Baseline to Week 26
Levodopa Administration Within 26 Weeks
Time Frame: 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.
Baseline to Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lundbeck A/S

Investigators

  • Principal Investigator: Email contact via H. Lundbeck A/S, LundbeckClinicalTrials@Lundbeck.com

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

March 13, 2012

First Submitted That Met QC Criteria

March 15, 2012

First Posted (ESTIMATE)

March 16, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

December 23, 2014

Last Update Submitted That Met QC Criteria

December 22, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13485A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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