CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 132 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Azilect® 1 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01268891
NCT01268891Phase 3Completed
CompareCT.gov

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

H. Lundbeck A/S·interventional·Posted Dec 31, 2010·Updated Dec 3, 2013

In Brief

A Phase 3 clinical trial evaluating Placebo and Azilect® for Parkinson's Disease. Completed, enrolled 132 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson's Disease
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 31, 2010
Enrollment StartJan 1, 2011
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 15.5 years ago

Interventions

Placebodrug

Once daily; tablet; orally; 18 weeks

Azilect®drug

1 mg daily; tablet; orally; 18 weeks