drugset / Trial / NCT01049984

Rasagiline as Add on to Dopamine Agonists in the Treatment of Parkinson's Disease

NCT01049984 ↗

Phase 4 Completed 328 enrolled Teva Neuroscience, Inc. H. Lundbeck A/S · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

To assess the efficacy of rasagiline 1 mg as a first add-on treatment to dopamine agonist therapy in early Parkinson Disease (PD) patients, , not optimally controlled on dopamine agonists as compared to placebo.

Timeline

Start
2009-12
Primary completion
2012-10
Completion
2012-10

Outcome

Met primary endpoint

registry analysis (superiority or other test); Rasagiline 1 mg vs Placebo; p = 0.012; Mean Difference (Final Values) -2.4 (95% CI -4.3 to -0.5); ANCOVA; NCT01049984 ↗

release “a double-blind, placebo controlled, randomized, multicenter study of Azilect® (rasagiline tablets) met its primary endpoint. The study, known as ANDANTE” tevapharm.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Rasagiline Small molecule 1 mg Oral

Indications