Who is sponsoring NCT01268891?

NCT01268891 is sponsored by H. Lundbeck A/S.

What condition does NCT01268891 study?

NCT01268891 studies Parkinson's Disease.

What drugs are being tested in NCT01268891?

Interventions: Placebo, Azilect®.

What is the status of NCT01268891?

NCT01268891 is currently COMPLETED.

Last reviewed 2013-10-07 · How we verify

Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of [Azilect®] Rasagiline in Levodopa-treated Parkinson's Patients With Motor Fluctuations in Korea

NCT01268891 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	H. Lundbeck A/S
Phase	Phase 3
Status	COMPLETED
Enrolment	132
Start date	2011-01

Conditions

Parkinson's Disease

Interventions

Placebo
Azilect®

Primary outcomes

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