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UnknownNCT04147949

AV-101 (L-4-chlorokynurenine) in Parkinson's Disease Subjects With Levodopa-Induced Dyskinesia

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

Status
Unknown
Phase
Phase 2
Study type
Interventional
Enrollment
20 (estimated)
Sponsor
VistaGen Therapeutics, Inc. · Industry
Sex
All
Age
30 Years – 80 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGAV-101Oral capsules taken twice daily for 14 days
DRUGPlaceboOral capsules taken twice a day for 14 days

Timeline

Start date
2022-08-01
Primary completion
2023-12-01
Completion
2024-04-01
First posted
2019-11-01
Last updated
2021-05-26

Regulatory

Source: ClinicalTrials.gov record NCT04147949. Inclusion in this directory is not an endorsement.