drugset / Trial / NCT01782222

Trial to Evaluate The Efficacy Of Rotigotine on Parkinson's Disease-Associated Motor Symptoms And Apathy

NCT01782222 ↗

Phase 4 Completed 122 enrolled UCB BIOSCIENCES, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This trial is being conducted to assess the effects of Rotigotine over Placebo on improvement of Apathy and motor symptoms in subjects with early-stage and advanced stage idiopathic Parkinson´s Disease.

Timeline

Start
2013-02
Primary completion
2014-01
Completion
2014-03

Outcome

Mixed primary results

registry Placebo vs Rotigotine, Low Dose; p = 0.977; Least Square Mean 0.04 (95% CI -2.42 to 2.50); ANCOVA NCT01782222 ↗

registry Placebo vs Rotigotine, Low Dose; p = 0.005; Least Square Mean -7.29 (95% CI -12.30 to -2.28); ANCOVA NCT01782222 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Rotigotine Unknown 2 mg Other
Subject Rotigotine Unknown 4 mg Other
Subject Rotigotine Unknown 6 mg Other
Subject Rotigotine Unknown 8 mg Other
Subject Rotigotine Unknown 16 mg Other

Indications