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Last Updated: May 28, 2020

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CLINICAL TRIALS PROFILE FOR AV-101


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Clinical Trials for AV-101

Trial ID Title Status Sponsor Phase Summary
NCT01483846 Safety, Tolerability and Pharmacokinetics of Multiple Doses of AV-101 in Healthy Volunteers Completed Cato Research Phase 1 This is a Phase 1b study involving multiple oral doses of AV-101 in healthy male and female subjects. The safety, pharmacokinetics, and antihyperalgesic effect of AV-101 on capsaicin-induced hyperalgesia will be assessed.
NCT01483846 Safety, Tolerability and Pharmacokinetics of Multiple Doses of AV-101 in Healthy Volunteers Completed National Institute on Drug Abuse (NIDA) Phase 1 This is a Phase 1b study involving multiple oral doses of AV-101 in healthy male and female subjects. The safety, pharmacokinetics, and antihyperalgesic effect of AV-101 on capsaicin-induced hyperalgesia will be assessed.
NCT01483846 Safety, Tolerability and Pharmacokinetics of Multiple Doses of AV-101 in Healthy Volunteers Completed VistaGen Therapeutics, Inc. Phase 1 This is a Phase 1b study involving multiple oral doses of AV-101 in healthy male and female subjects. The safety, pharmacokinetics, and antihyperalgesic effect of AV-101 on capsaicin-induced hyperalgesia will be assessed.
NCT03078322 AV-101 as Adjunct Antidepressant Therapy in Patients With Major Depression Not yet recruiting VistaGen Therapeutics, Inc. Phase 2 The study will evaluate the safety and efficacy of AV-101.
NCT03583554 Electrophysiological Biomarkers of AV-101 Not yet recruiting Michael Debakey Veterans Affairs Medical Center Phase 1/Phase 2 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.
NCT03583554 Electrophysiological Biomarkers of AV-101 Not yet recruiting VistaGen Therapeutics, Inc. Phase 1/Phase 2 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.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for AV-101

Condition Name

Condition Name for
Intervention Trials
Healthy 1
Dyskinesia, Medication-Induced 1
Parkinson Disease 1
Neuropathic Pain 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Depressive Disorder, Major 1
Depressive Disorder 1
Depression 1
Neuralgia 1
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Clinical Trial Locations for AV-101

Trials by Country

Trials by Country for
Location Trials
United States 1
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Trials by US State

Trials by US State for
Location Trials
California 1
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Clinical Trial Progress for AV-101

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 2 2
Phase 1/Phase 2 1
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Not yet recruiting 3
Completed 1
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Clinical Trial Sponsors for AV-101

Sponsor Name

Sponsor Name for
Sponsor Trials
VistaGen Therapeutics, Inc. 4
Michael Debakey Veterans Affairs Medical Center 1
National Institute on Drug Abuse (NIDA) 1
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 5
NIH 1
Other 1
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