drugset / Trial / NCT01523301

Rotigotine Versus Placebo to Evaluate the Efficacy on Depressive Symptoms in Idiopathic Parkinson's Disease Patients

NCT01523301 ↗

Phase 4 Completed 380 enrolled UCB Pharma
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study was to show superiority of Rotigotine over placebo on improvement of depressive symptoms in subjects with idiopathic Parkinson's disease.

Timeline

Start
2012-04
Primary completion
2014-10
Completion
2014-10

Outcome

Missed primary endpoint

registry p =0.1286; Difference in LS Mean -1.12 (95% CI -2.56 to 0.33) NCT01523301 ↗

paper No statistically significant improvement in depressive symptoms were observed with rotigotine versus placebo. PMID 27322571 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Rotigotine Unknown 8 mg Other
Subject Rotigotine Unknown 16 mg Other

Indications