Clinical Trial of AVL-3288 in Schizophrenia Patients

• Status: Completed
• Trial end date: 2018-11-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborator: National Institute of Mental Health (NIMH)

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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