E2007 as adjunct treatment to levodopa in patients with PD

Sponsor:
Eisai Medical Research

PI:
Charles H. Adler, MD, PhD

Co-investigators:
Virgilio Evidente, MD ; Erika Driver-Dunckley, MD

This is a randomized, double-blind, placebo-controlled, parallel group study of the efficacy and safety of 2 mg/d and 4 mg/d of E2007 (an investigational drug), and placebo in levodopa treated Parkinson’s Disease (PD) patients with motor fluctuations. Treatment will be given orally from Day 0 through Week 20 with follow-up lasting up to 24 weeks (there is a 2-3 week screening period before treatment begins). Safety and efficacy will be monitored at multiple scheduled visits. This is a phase 3 study and the study sponsor is Eisai Medical Research, Inc.

The primary objective of this study is to compare the efficacy of 2 mg and 4 mg of E2007, and placebo on duration of daily “OFF” state in patients with PD who experience end-of-dose “wearing off” motor fluctuations. The primary efficacy measure will be the patient diaries: Change from Baseline to Week 20 visit in the mean total daily “OFF” time (hr). Secondary endpoints include: 1) Change from Baseline on the average “OFF” time over total study treatment period 2) UPDRS Part II (ADL): “OFF” state 3) UPDRS Part III (Motor): “ON” state 4) Change from Baseline to End-of-Treatment Visit in the mean total daily “ON” time without dyskinesias or with no troublesome dyskinesias from patient diaries 5) CGIC improvement 6) Change from Baseline in total daily levodopa use.