drugset / Trial / NCT01268891

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

NCT01268891 ↗

Phase 3 Completed 132 enrolled H. Lundbeck A/S
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2011-01
Primary completion
2012-06
Completion
—

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Placebo vs Azilect®; p = 0.3257; Mean Difference (Final Values) -0.35 (90% CI -0.93 to 0.23); ANCOVA; NCT01268891 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Rasagiline Small molecule 1 mg Oral

Indications