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

NCT ID: NCT01268891

Last Updated: 2013-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31

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.

Conditions

Parkinson's Disease

Keywords

Azilect; Motor fluctuations; Parkinson´s Disease; Rasagiline

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Once daily; tablet; orally; 18 weeks

Azilect®

Group Type: EXPERIMENTAL

Azilect®

Intervention Type: DRUG

1 mg daily; tablet; orally; 18 weeks

Interventions

Placebo

Once daily; tablet; orally; 18 weeks

Intervention Type: DRUG

Azilect®

1 mg daily; tablet; orally; 18 weeks

Intervention Type: DRUG

Other Intervention Names

Rasagiline

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

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@lundbeck.com

Countries

South Korea

Other Identifiers

13484A

Identifier Type: -

Identifier Source: org_study_id