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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT01556165
First received: March 13, 2012
Last updated: December 22, 2014
Last verified: December 2014
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease
Drug: rasagiline
Drug: placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:
  • Change From Baseline to Week 26 in UPDRS Total Score [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
    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:
  • Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part I) [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
    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)

  • Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part III) [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
    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.


Enrollment: 130
Study Start Date: April 2012
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rasagiline Drug: rasagiline
1 mg/day, tablets, once daily, orally
Other Name: Azilect
Placebo Comparator: placebo Drug: placebo
tablets, once daily, orally

  Eligibility

Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01556165

Locations
China
CN015
Beijing, China, 100034
CN001
Beijing, China, 100730
CN011
Chengdu, China, 610041
CN005
Guangzhou, China, 510180
CN003
Guangzhou, China, 510120
CN017
Guangzhou, China, 510260
CN004
Hangzhou, China, 310009
CN012
Shanghai, China, 200025
CN007
Shanghai, China, 200040
CN013
Shanghai, China, 200127
CN006
Suzhou, China, 215004
CN009
Wuhan, China, 430022
CN016
Wuhan, China, 430030
CN010
Xi'an, China, 710032
CN014
Xi'an, China, 710061
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Principal Investigator: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
  More Information

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT01556165     History of Changes
Other Study ID Numbers: 13485A 
Study First Received: March 13, 2012
Results First Received: December 4, 2014
Last Updated: December 22, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by H. Lundbeck A/S:
Rasagiline
Azilect
Parkinson´s Disease
Motor fluctuations

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Rasagiline
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on July 24, 2016