AV-101 (L-4-chlorokynurenine) in Parkinson's Disease Subjects With Levodopa-Induced Dyskinesia
Status:
Not yet recruiting
Trial end date:
2024-04-01
Target enrollment:
Participant gender:
Summary
This is a randomized, double-blind, placebo-controlled, crossover, proof-of-concept Phase 2
study to test efficacy and safety of AV-101 (L-4-chlorokynurenine) in Parkinson's Disease
subjects with levodopa-induced dyskinesia. The trial will be conducted in two treatment
periods, in which each treatment period will consist of 14 days. The two treatment periods
will be separated by a 1-week washout period. During the first treatment period, subjects
meeting all eligibility criteria will be randomly assigned to receive either 1440 mg AV-101
or placebo in a 1:1 ratio. AV-101 or placebo will be administered BID for 14 days (every 12
hours). After the washout period, all subjects will be crossed over to receive the alternate
treatment during the second treatment period (14-day period).
On the last day of each treatment period (Visit 4 [Day 14] and Visit 7 [Day35]), subjects
will be assessed in clinic while in the practically "off" state and will receive the morning
dose of the study drug at the clinic. This will be followed, within 25-30 minutes, by oral
administration of a dose of levodopa that is 150% of the subject's normal dose. Assessments
of dyskinesia and PD motor symptoms will be performed before and after levodopa/carbidopa
administration.