Clinical trial NCT01268891: Study of Azilect® (Rasagiline) in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations in Korea
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease
Keywords: Azilect
Motor fluctuations
Parkinson´s Disease
Rasagiline
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2010-12-31
Enrollment: 132
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Change From Baseline in Mean Total Daily OFF Time Using Parkinson's Disease Patient Diary
timeFrame: Baseline and Weeks 6, 10, 14, and 18
Secondary outcomes:
measure: Clinical Status Using CGI-I Score During ON Time
timeFrame: Week 18
measure: Change From Baseline in UPDRS-ADL Score During OFF Time
timeFrame: Baseline and Week 18
measure: Change From Baseline in UPDRS Motor Score During ON Time
timeFrame: Baseline and Week 18
Other outcomes:
Locations:
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: