A Study to Examine the Effect of Levodopa-Carbidopa Intestinal Gel (LCIG) Therapy Relative to That of Optimized Medical Treatment (OMT) on Non-motor Symptoms (NMS) Associated With Advanced Parkinson's Disease (PD)

Summary

The primary objective of this study is to examine the effect of LCIG relative to that of OMT on NMS associated with PD.

Timeline

Start

2015-10-26

Primary completion

2020-05-14

Completion

2022-11-18

Outcome

Missed primary endpoint

registry analysis (superiority test); Optimized Medical Treatment vs LCIG; p = 0.410; Least Squares (LS) Mean of Difference -8.21 (95% CI -27.98 to 11.55) NCT02549092 ↗

registry analysis (superiority test); Optimized Medical Treatment vs LCIG; p = 0.509; LS Mean of Difference 1.57 (95% CI -3.16 to 6.30) NCT02549092 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Levodopa-Carbidopa Intestinal Gel	Unknown	—	—

Indications