NE3107 Activity and Safety in Patients With Parkinson's Disease Using Levodopa
Status:
Not yet recruiting
Trial end date:
2022-08-01
Target enrollment:
Participant gender:
Summary
A 28-day phase 2a, double-blind, placebo-controlled (1:1), multi-center study of 20 mg
NE3107, twice daily of safety, potential drug-drug interactions, and MDS-UPDRS defined
activity in patients with Parkinson's disease . Study will enroll 40 patients that are
currently taking immediate release levodopa/ carbidopa (IRLC) and have a practically defined
off-state for IRLC. Day one- baseline UPDRS and IRLC PK sampling; day 2- start NE3107 dosing,
assess UPDRS during onset and NE3107 PK sampling, rescue meds as needed after 4 hours; day 3
and 14- NE3107 + IRLC UPDRS assessment and PK sampling; day 28- NE3107 + IRLC UPDRS
assessments. Overnight stays in clinic prior to Day 1-3, 14, and 28.