Clinical Trial of AVL-3288 in Schizophrenia Patients

NCT02978599 | Completed Phase 1 DMC

• 2 other identifiers: 7370U01MH094247-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Single-center, outpatient, randomized, double-blind, placebo-controlled, 3-treatment-phase, cross-over study to evaluate the safety, tolerability and efficacy of two oral doses of AVL-3288 each compared to placebo, in patients with schizophrenia.

Conditions

Schizophrenia; Schizoaffective Disorder

Outcome Measures

Primary Outcomes (1)

• Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Score

  Compare effect of active drug (AVL-3288) to placebo on RBANS total score

  End of each 5-day treatment phase

Secondary Outcomes (6)

• RBANS index T-score subscales

  End of each 5-day treatment phase

• Brief Psychiatric Rating Scale (BPRS) Total score

  End of each 5-day treatment phase

• Calgary Depression Rating Scale (CDRS) Total score

  End of each 5-day treatment phase

• Scale for the Assessment of Negative Symptoms (SANS) Total score

  End of each 5-day treatment phase

• P50 suppression measured by electroencephalographic (EEG)

  End of each 5-day treatment phase

Study Arms (3)

AVL-3288 10 mg

EXPERIMENTAL

AVL-3288 10 mg daily for 5 days

Drug: AVL-3288

AVL-3288 30 mg

EXPERIMENTAL

AVL-3288 30 mg daily for 5 days

Drug: AVL-3288

Placebo

PLACEBO COMPARATOR

Placebo daily for 5 days

Drug: Placebo

Interventions

AVL-3288 DRUG

daily for 5 days

Also known as: Anvylic-3288

AVL-3288 10 mg; AVL-3288 30 mg

Placebo DRUG

daily for 5 days

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• DSM-V diagnosis of schizophrenia or schizoaffective disorder
• RBANS Total Scale Score \>62
• Willing to provide informed consent
• Medically stable for study participation
• Taking an antipsychotic medication other than clozapine at a stable dose for at least 4 weeks
• Judged clinically not to be at significant suicide or violence risk

You may not qualify if:

• Substance abuse (excluding nicotine) within last 90 days
• ECG abnormality that is clinically significant
• Current clozapine use
• Participation in a study of investigational medication/device within 4 weeks
• Pregnancy, lactation, or lack of use of effective birth control
• Active tobacco use
• Presence or positive history of significant medical or neurological illness, including cardiac illness, WBC \<3500/mm3, absolute neutrophil count \<1500/mm3, ALT or AST values \>1.5 times upper limit of normal. Hemoglobin less than 130 g/L (13 g/dL) in males or 120 g/L (12 g/dL) in females or known HIV +
• Contraindication to MRI scanning, including metal implants or claustrophobia
• Medicinal patch, unless removed

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

AVL3288

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Jeffrey A Lieberman, MD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Psychiatry

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: December 1, 2016
• Study Start: November 1, 2016
• Primary Completion: October 26, 2018
• Study Completion: November 2, 2018
• Last Updated: January 22, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)