MedTrace Logo

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

NCT04147949 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-05-26

No results posted yet for this study

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

  • Parkinson Disease
  • Dyskinesia, Medication-Induced
  • L-Dopa Causing Adverse Effects in Therapeutic Use

Interventions

DRUG

AV-101

Oral capsules taken twice daily for 14 days

DRUG

Placebo

Oral capsules taken twice a day for 14 days

Sponsors & Collaborators

  • VistaGen Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-31
Primary Completion
2023-12-31
Completion
2024-04-30
FDA Drug
Yes

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04147949 on ClinicalTrials.gov