At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 18 enrolled

Drug / intervention

Placebo +2 moredrug

Likely dose

AV-101 720 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03583554

NCT03583554Phase 2Completed

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Electrophysiological Biomarkers of Kynurenine Pathway Modulator AV-101 in Healthy Volunteers: Treating Suicidal Veterans

Marijn Lijffijt, PhD·interventional·Posted Jul 11, 2018·Updated Feb 17, 2022

In Brief

A Phase 2 clinical trial evaluating Placebo, AV-101 720 mg, and 1 other intervention for Healthy. Completed, enrolled 18 participants across 1 site.

Detailed Summary

Suicide is 2-7x higher in Veterans than non-veterans, and may be related to brain kynurenine pathway (KP) dysregulation and NMDA receptor (NMDAR) hyperactivation. Experimental drug "AV-101" modulates the brain KP, with possible downstream NMDAR deactivation. The investigators will examine AV-101 NMDAR modulation by testing dose-response effects on resting state EEG, Mismatch Negativity, and P50 gating. Twelve healthy Operation Enduring Freedom (OEF) Operation Iraqi Freedom (OIF) and Operation New Dawn (OND) Veterans will be administered single dose AV-101 720 mg, 1440 mg, and placebo over 3 weeks in a randomized, double-blind, cross-over trial. Repeated measures General Linear Models will test dose-response effects. Suicide prevention is an important Veterans Affair (VA) mission. This study is a first step to testing anti-suicidal effects of AV-101 in Veterans.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHealthy

CountriesUnited States

CollaboratorsMichael E. DeBakey VA Medical Center, VistaGen Therapeutics, Inc.

Timeline

Phase 2CompletedFinished

20192020202120222023202420252026

First PostedJul 2018

Enrollment StartSep 2018

Primary CompletionOct 2019

TodayJul 2026

First PostedJul 11, 2018

Enrollment StartSep 1, 2018

Primary CompletionOct 19, 2019

TodayJul 2, 2026

Enrollment to primary: 1.1 yearsPosted 8.0 years ago

Interventions

Placebodrug

Single dose of 4 placebo oral capsules

AV-101 720 mgdrug

Single dose of 2 360 mg AV-101 oral capsules + 2 placebo oral capsules

AV-101 1440 mgdrug

Single dose of 4 360 mg AV-101 oral capsules