Clinical Trial of AVL-3288 in Schizophrenia Patients

Schizophrenia Clinical Trial

Official title:

Double Blind, Two Dose, Cross-over Clinical Trial of the Positive Allosteric Modulator at the alpha7 Nicotinic Cholinergic Receptor AVL-3288 in Schizophrenia Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02978599
• Other study ID #: 7370
• Secondary ID: U01MH094247-01
• Status: Completed
• Phase: Phase 1
• Start date: November 2016
• Est. completion date: November 2, 2018

Study information

• Verified date: January 2019
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2, 2018
• Est. primary completion date: October 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Drug:
• AVL-3288
daily for 5 days
• Placebo
daily for 5 days

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	RBANS index T-score subscales	Compare effect of active drug (AVL-3288) to placebo on RBANS index T-score subscales	End of each 5-day treatment phase
Secondary	Brief Psychiatric Rating Scale (BPRS) Total score	Compare effect of active drug (AVL-3288) to placebo on BPRS Total Score.	End of each 5-day treatment phase
Secondary	Calgary Depression Rating Scale (CDRS) Total score	Compare effect of active drug (AVL-3288) to placebo on CDRS Total Score.	End of each 5-day treatment phase
Secondary	Scale for the Assessment of Negative Symptoms (SANS) Total score	Compare effect of active drug (AVL-3288) to placebo on SANS Total score	End of each 5-day treatment phase
Secondary	P50 suppression measured by electroencephalographic (EEG)	Compare P50 suppression measured by EEG between active drug (AVL-3288) and placebo	End of each 5-day treatment phase
Secondary	Intensity of hippocampal BOLD fMRI signal during MRI scan	Compare intensity of Hippocampal BOLD signal between active drug (AVL-3288) and placebo	end of each 5-day treatment phase