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Clinical Trial of AVL-3288 in Schizophrenia Patients

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AVL-3288
Placebo
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

AVL-3288 10 mg

AVL-3288 30 mg

Placebo

Arm Description

AVL-3288 10 mg daily for 5 days

AVL-3288 30 mg daily for 5 days

Placebo daily for 5 days

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

RBANS index T-score subscales
Compare effect of active drug (AVL-3288) to placebo on RBANS index T-score subscales
Brief Psychiatric Rating Scale (BPRS) Total score
Compare effect of active drug (AVL-3288) to placebo on BPRS Total Score.
Calgary Depression Rating Scale (CDRS) Total score
Compare effect of active drug (AVL-3288) to placebo on CDRS Total Score.
Scale for the Assessment of Negative Symptoms (SANS) Total score
Compare effect of active drug (AVL-3288) to placebo on SANS Total score
P50 suppression measured by electroencephalographic (EEG)
Compare P50 suppression measured by EEG between active drug (AVL-3288) and placebo
Intensity of hippocampal BOLD fMRI signal during MRI scan
Compare intensity of Hippocampal BOLD signal between active drug (AVL-3288) and placebo

Full Information

First Posted
November 17, 2016
Last Updated
January 17, 2019
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02978599
Brief Title
Clinical Trial of AVL-3288 in Schizophrenia Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
October 26, 2018 (Actual)
Study Completion Date
November 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AVL-3288 10 mg
Arm Type
Experimental
Arm Description
AVL-3288 10 mg daily for 5 days
Arm Title
AVL-3288 30 mg
Arm Type
Experimental
Arm Description
AVL-3288 30 mg daily for 5 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo daily for 5 days
Intervention Type
Drug
Intervention Name(s)
AVL-3288
Other Intervention Name(s)
Anvylic-3288
Intervention Description
daily for 5 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
daily for 5 days
Primary Outcome Measure Information:
Title
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Score
Description
Compare effect of active drug (AVL-3288) to placebo on RBANS total score
Time Frame
End of each 5-day treatment phase
Secondary Outcome Measure Information:
Title
RBANS index T-score subscales
Description
Compare effect of active drug (AVL-3288) to placebo on RBANS index T-score subscales
Time Frame
End of each 5-day treatment phase
Title
Brief Psychiatric Rating Scale (BPRS) Total score
Description
Compare effect of active drug (AVL-3288) to placebo on BPRS Total Score.
Time Frame
End of each 5-day treatment phase
Title
Calgary Depression Rating Scale (CDRS) Total score
Description
Compare effect of active drug (AVL-3288) to placebo on CDRS Total Score.
Time Frame
End of each 5-day treatment phase
Title
Scale for the Assessment of Negative Symptoms (SANS) Total score
Description
Compare effect of active drug (AVL-3288) to placebo on SANS Total score
Time Frame
End of each 5-day treatment phase
Title
P50 suppression measured by electroencephalographic (EEG)
Description
Compare P50 suppression measured by EEG between active drug (AVL-3288) and placebo
Time Frame
End of each 5-day treatment phase
Title
Intensity of hippocampal BOLD fMRI signal during MRI scan
Description
Compare intensity of Hippocampal BOLD signal between active drug (AVL-3288) and placebo
Time Frame
end of each 5-day treatment phase

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey A Lieberman, MD
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Clinical Trial of AVL-3288 in Schizophrenia Patients

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