Clinical Trial of AVL-3288 in Schizophrenia Patients

New York State Psychiatric Institute

Status and phase: Completed; Phase 1

Conditions: Schizophrenia; Schizoaffective Disorder

Treatments: Drug: Placebo; Drug: AVL-3288

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02978599

7370

U01MH094247-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

This study will be in 24 non-smoking outpatients with schizophrenia or schizoaffective disorder. Subjects will complete three treatment phases, each involving 5 straight days of taking AVL-3288 (10 mg or 30 mg study drug or placebo) followed by a 16 day washout period in which subjects do not take the study drug to ensure that the drug is completed eliminated from the body before the next phase.

Enrollment: 24 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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24 participants in 3 patient groups, including a placebo group

AVL-3288 10 mg

Experimental group

Description:

AVL-3288 10 mg daily for 5 days

Treatment:

Drug: AVL-3288

AVL-3288 30 mg

Experimental group

Description:

AVL-3288 30 mg daily for 5 days

Treatment:

Drug: AVL-3288

Placebo

Placebo Comparator group

Description:

Placebo daily for 5 days

Treatment:

Drug: Placebo