Study of Azilect® (Rasagiline) in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations in Korea
|ClinicalTrials.gov Identifier: NCT01268891|
Recruitment Status : Completed
First Posted : December 31, 2010
Results First Posted : December 3, 2013
Last Update Posted : December 3, 2013
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Drug: Placebo Drug: Azilect®||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||132 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Study Start Date :||January 2011|
|Primary Completion Date :||June 2012|
|Placebo Comparator: Placebo||
Once daily; tablet; orally; 18 weeks
1 mg daily; tablet; orally; 18 weeks
Other Name: Rasagiline
- 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 ]
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.
- Clinical Status Using CGI-I Score During ON Time [ Time Frame: Week 18 ]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 ]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 ]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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01268891
|Study Director:||Email contact via H. Lundbeck A/S||LundbeckClinicalTrials@lundbeck.com|