Study of Azilect® (Rasagiline) in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations in Korea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT01268891
First received: December 30, 2010
Last updated: October 7, 2013
Last verified: October 2013
  Purpose

To evaluate the efficacy of a fixed dose of Azilect® (1 mg/day) vs placebo as assessed by the change from baseline in mean total daily OFF time during 18 weeks of treatment in levodopa-treated Parkinson's Disease (PD) patients with motor fluctuations in Korea.


Condition Intervention Phase
Parkinson's Disease
Drug: Placebo
Drug: Azilect®
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 [Azilect®] Rasagiline in Levodopa-treated Parkinson's Patients With Motor Fluctuations in Korea

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change From Baseline in Mean Total Daily OFF Time Using Parkinson's Disease Patient Diary [ Time Frame: Baseline and Weeks 6, 10, 14, and 18 ] [ Designated as safety issue: No ]

    Parkinson's Disease Patient Diary is a self-administered diary designed to assess motor fluctuations throughout the day. It is divided into 30-minute intervals, and the patient selects one of four options for each interval: asleep; off; on with no dyskinesia or without troublesome dyskinesia; or on with troublesome dyskinesia.

    The Change From Baseline in Mean Total Daily OFF Time is calculated by taking the difference between the average of the total daily OFF time at Weeks 6, 10, 14 and 18, and the Baseline Total Daily OFF Time.



Secondary Outcome Measures:
  • Clinical Status Using CGI-I Score During ON Time [ Time Frame: Week 18 ] [ Designated as safety issue: No ]
    Clinical Global Impression - Global Improvement (CGI-I) is a single-item rating scale used to evaluate a patient's condition relative to baseline on a 7-point scale, regardless of whether the improvement is related to the investigational medicinal product (IMP). The scale ranges from 1 (very much improved) to 7 (very much worse).

  • Change From Baseline in UPDRS-ADL Score During OFF Time [ Time Frame: Baseline and Week 18 ] [ Designated as safety issue: No ]
    Unified Parkinson's Disease Rating Scale (UPDRS) is a 42-item rating scale designed to assess Parkinson's Disease-related disability and impairment using a patient interview and a physical examination. It has 4 parts and 4 subsection scores. A higher score indicates a worst outcome. I: mentation, behaviour and mood symptoms - 0 to 16; II: activities of daily living (ADL) - 0 to 52; III: motor function - 0 to 108; IV: complications of dopaminergic therapy - 0 to 23. Subsection scores for I to III are used to calculate a total score that ranges from 0 (no disability) to 176 (total dependence).

  • Change From Baseline in UPDRS Motor Score During ON Time [ Time Frame: Baseline and Week 18 ] [ Designated as safety issue: No ]
    UPDRS is a 42-item rating scale designed to assess Parkinson's Disease-related disability and impairment using a patient interview and a physical examination. It has 4 parts and 4 subsection scores. A higher score indicates a worst outcome. I: mentation, behaviour and mood symptoms - 0 to 16; II: ADL - 0 to 52; III: motor function - 0 to 108; IV: complications of dopaminergic therapy - 0 to 23. Subsection scores for I to III are used to calculate a total score that ranges from 0 (no disability) to 176 (total dependence).


Enrollment: 132
Study Start Date: January 2011
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Once daily; tablet; orally; 18 weeks
Experimental: Azilect® Drug: Azilect®
1 mg daily; tablet; orally; 18 weeks
Other Name: Rasagiline

Detailed Description:

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 Azilect®, a monoamine oxidase type B (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. Azilect® is approved for treatment of PD in Europe and the US.

The objective of this study is to evaluate the efficacy, tolerability, and safety of Azilect® compared to placebo in Korean PD patients with motor fluctuations on levodopa therapy.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with idiopathic PD
  • Patients with motor fluctuations averaging at least 1 hour daily in the OFF state during the waking hours (not including morning akinesia)
  • Patients with a Modified Hoehn and Yahr stage <5 in the OFF state
  • Patients taking optimised levodopa/DOPA decarboxylase inhibitor (DDI) therapy for at least 14 days prior to baseline
  • Patients receiving at least 3 daily doses of levodopa, not including a bedtime dose, and not more than 8 daily doses of levodopa
  • Patient who have demonstrated the ability to keep accurate 24-hour diaries prior to randomisation

Exclusion Criteria:

  • Patients with a clinically significant or unstable medical or surgical condition that would preclude his/her safe and complete study participation
  • Patients taking any disallowed medication according to the Azilect® approved label
  • Patients taking MAO inhibitors within 3 months prior to baseline visit
  • Patients with a known serious adverse reaction to selegiline
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01268891

Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
  More Information

No publications provided

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT01268891     History of Changes
Other Study ID Numbers: 13484A
Study First Received: December 30, 2010
Results First Received: June 28, 2013
Last Updated: October 7, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

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
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
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 April 17, 2014