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

NCT01268891 | Completed Phase 3 Results

• 1 other identifier: 13484A
• Study Type: interventional
• Target: 132
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parkinson's Disease

Keywords

Azilect; Motor fluctuations; Parkinson´s Disease; Rasagiline

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Mean Total Daily OFF Time Using Parkinson's Disease Patient Diary

  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.

  Baseline and Weeks 6, 10, 14, and 18

Secondary Outcomes (3)

• Clinical Status Using CGI-I Score During ON Time

  Week 18

• Change From Baseline in UPDRS-ADL Score During OFF Time

  Baseline and Week 18

• Change From Baseline in UPDRS Motor Score During ON Time

  Baseline and Week 18

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Azilect®

EXPERIMENTAL

Drug: Azilect®

Interventions

Placebo DRUG

Once daily; tablet; orally; 18 weeks

Placebo

Azilect® DRUG

1 mg daily; tablet; orally; 18 weeks

Also known as: Rasagiline

Azilect®

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lundbeck A/S: lead

MeSH Terms

Conditions

Parkinson Disease

Interventions

rasagiline

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: H. Lundbeck A/S
• Organization: H. Lundbeck A/S

LundbeckClinicalTrials@lundbeck.com

+45 3630 1311

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@lundbeck.com

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2010
• First Posted: December 31, 2010
• Study Start: January 1, 2011
• Primary Completion: June 1, 2012
• Last Updated: December 3, 2013
• Results First Posted: December 3, 2013

Record last verified: 2013-10