drugset / Trial / NCT01479530

Azilect® (Rasagiline) in Levodopa-treated Parkinson's Patients With Motor Fluctuations in China

NCT01479530 ↗

Phase 3 Completed 321 enrolled H. Lundbeck A/S
RandomizedParallel-groupTriple-blindTreatment

Summary

The rationale for conducting this study is to evaluate the efficacy, tolerability, and safety of rasagiline compared to placebo in levodopa-treated Parkinson's Disease (PD) Chinese patients with motor fluctuations. Azilect® (Rasagiline) is indicated for the treatment of idiopathic PD as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.

Timeline

Start
2011-12
Primary completion
2013-06
Completion
2013-06

Outcome

Met primary endpoint

paper rasagiline statistically significantly reduced the mean [95% confidence interval] total daily OFF time versus placebo (- 0.5 h [- 0.92, - 0.07]; p = 0.023). PMID 29988514 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Rasagiline Small molecule 1 mg Oral

Indications