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Clinical Trial of AVL-3288 in Schizophrenia Patients

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ClinicalTrials.gov Identifier: NCT02978599
Recruitment Status : Recruiting
First Posted : December 1, 2016
Last Update Posted : April 9, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Drug: AVL-3288 Drug: Placebo Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : November 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: AVL-3288 10 mg
AVL-3288 10 mg daily for 5 days
Drug: AVL-3288
daily for 5 days
Other Name: Anvylic-3288

Experimental: AVL-3288 30 mg
AVL-3288 30 mg daily for 5 days
Drug: AVL-3288
daily for 5 days
Other Name: Anvylic-3288

Placebo Comparator: Placebo
Placebo daily for 5 days
Drug: Placebo
daily for 5 days




Primary Outcome Measures :
  1. Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Score [ Time Frame: End of each 5-day treatment phase ]
    Compare effect of active drug (AVL-3288) to placebo on RBANS total score


Secondary Outcome Measures :
  1. RBANS index T-score subscales [ Time Frame: End of each 5-day treatment phase ]
    Compare effect of active drug (AVL-3288) to placebo on RBANS index T-score subscales

  2. Brief Psychiatric Rating Scale (BPRS) Total score [ Time Frame: End of each 5-day treatment phase ]
    Compare effect of active drug (AVL-3288) to placebo on BPRS Total Score.

  3. Calgary Depression Rating Scale (CDRS) Total score [ Time Frame: End of each 5-day treatment phase ]
    Compare effect of active drug (AVL-3288) to placebo on CDRS Total Score.

  4. Scale for the Assessment of Negative Symptoms (SANS) Total score [ Time Frame: End of each 5-day treatment phase ]
    Compare effect of active drug (AVL-3288) to placebo on SANS Total score

  5. P50 suppression measured by electroencephalographic (EEG) [ Time Frame: End of each 5-day treatment phase ]
    Compare P50 suppression measured by EEG between active drug (AVL-3288) and placebo

  6. Intensity of hippocampal BOLD fMRI signal during MRI scan [ Time Frame: end of each 5-day treatment phase ]
    Compare intensity of Hippocampal BOLD signal between active drug (AVL-3288) and placebo



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02978599


Contacts
Contact: Marlene Carlson, MPH 646-774-8436 mcarlson@nyspi.columbia.edu

Locations
United States, New York
New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Contact: Marlene Carlson, MPH    646-774-8436    mcarlson@nyspi.columbia.edu   
Principal Investigator: Joshua T Kantrowitz, MD         
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Jeffrey A Lieberman, MD New York State Psychiatric Institute

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT02978599     History of Changes
Other Study ID Numbers: 7370
U01MH094247-01 ( U.S. NIH Grant/Contract )
First Posted: December 1, 2016    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders