A Study to Assess the Efficacy, Safety and Tolerability of ABT-SLV187 Monotherapy in Subjects With Advanced Parkinson's Disease (PD) and Persistent Motor Complications, Despite Optimized Treatment With Available Anti-Parkinsonian Medications

Summary

The primary objective of this study is to measure the efficacy of ABT-SLV187 in subjects with advanced Parkinson's disease.

Timeline

Start

2013-10

Primary completion

2015-03

Completion

2015-03

Outcome

Met primary endpoint

registry Negative change from baseline for "off" time indicates improvement. NCT01960842 ↗

registry p <0.001; Mean Difference (Net) -4.64 (95% CI -5.78 to -3.50); One-sample t-test, 2-sided NCT01960842 ↗

Publications

• Results Murata M, Mihara M, Hasegawa K, Jeon B, Tsai CH, Nishikawa N, Oeda T, Yokoyama M, Robieson WZ, Ryman D, Eaton S, Chatamra K, Benesh J. Efficacy and safety of levodopa-carbidopa intestinal gel from a study in Japanese, Taiwanese, and Korean advanced Parkinson's disease patients. NPJ Parkinsons Dis. 2016 Nov 3;2:16020. doi: 10.1038/npjparkd.2016.20. eCollection 2016.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Levodopa-carbidopa intestinal gel	Unknown	—	Other

Indications