Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Negative Symptoms of Schizophrenia

NCT03896945 | Terminated Phase 2 FDA Drug

• 2 other identifiers: 18-AVP-786-2072021-001352-33
• Study Type: interventional
• Target: 136
• Locations: 4 countries
• Sites: 72

Brief Summary

This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786, as compared with placebo, for the treatment of negative symptoms of schizophrenia.

Conditions

Schizophrenia

Keywords

Negative Symptoms; Schizophrenia; AVP-786

Outcome Measures

Primary Outcomes (1)

• Change from Baseline to Week 15 in the Positive and Negative Syndrome Scale (PANSS) Marder Negative Factors Score

  Baseline; Week 15

Secondary Outcomes (3)

• Change from Baseline to Week 15 in the Negative Symptom Assessment-16 (NSA-16) Global Negative Symptom Score

  Baseline; Week 15

• Change from Baseline to Week 15 in the Patient Global Impression of Severity (PGI-S) Score

  Baseline; Week 15

• Change from Baseline to Week 15 in the Patient Global Impression of Change (PGI-C) Score

  Baseline; Week 15

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo capsules will be administered orally twice a day over a 15-week period.

Drug: Placebo

AVP-786

EXPERIMENTAL

AVP-786 capsules will be administered orally twice a day over a 15-week period.

Drug: AVP-786

Interventions

Placebo DRUG

oral capsules

Placebo

AVP-786 DRUG

oral capsules

AVP-786

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants who meet the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) diagnostic criteria for schizophrenia confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I) Version 7.0.2
• Participants must have well-controlled positive symptoms and prominent negative symptoms as defined by Positive and Negative Syndrome Scale (PANSS) criteria.
• Participants currently receiving a second-generation atypical antipsychotic drug (SGA) are eligible if they are stable and adherent to their dosing schedule.
• Participants must have a reliable informant (e.g., case manager, social worker, family member). The informant should be able to spend an adequate amount of time with the participant to be able to address behaviors, activities, and symptoms.

You may not qualify if:

• Participants with current major depressive disorder (MDD)
• Participants with pseudo-parkinsonism secondary to their ongoing antipsychotic medication
• Participants currently using anticholinergic medications
• Participants recently hospitalized as in-patients

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (72)

Clinical Research Site

Little Rock, Arkansas, 72209, United States

Location

Clinical Research Site #840-041

Anaheim, California, 92805, United States

Location

Clinical Research Site #840-013

Bellflower, California, 90706, United States

Location

Clinical Research Site #840-079

Costa Mesa, California, 92626, United States

Location

Clinical Research Site #840-027

Culver City, California, 90230, United States

Location

Clinical Research Site #840-006

Garden Grove, California, 92845, United States

Location

Clinical Research Site #840-026

Glendale, California, 91206, United States

Location

Clinical Research Site# 840-067

La Habra, California, 90631, United States

Location

Clinical Research Site# 840-083

Lafayette, California, 94549, United States

Location

Clinical Research Site 840-002

Lemon Grove, California, 91945, United States

Location

Clinical Research Site

Oakland, California, 94607, United States

Location

Clinical Research Site #840-035

Oceanside, California, 92056, United States

Location

Clinical Research Site# 840-010

Panorama City, California, 91402, United States

Location

Clinical Research Site #840-012

Riverside, California, 92506, United States

Location

Clinical Research Site# 840-081

San Bernardino, California, 92408, United States

Location

Clinical Research Site #840-005

San Diego, California, 92102, United States

Location

Clinical Research Site #840-096

Santee, California, 92071, United States

Location

Clinical Research Site #840-015

Torrance, California, 90502, United States

Location

Clinical Research Site# 840-094

Doral, Florida, 33178, United States

Location

Clinical Research Site #840-046

Hollywood, Florida, 33021, United States

Location

Clinical Research Site Site #840-093

Homestead, Florida, 33030, United States

Location

Clinical Research Site #840-062

Lakeland, Florida, 33803, United States

Location

Clinical Research Site #840-024

Largo, Florida, 33770, United States

Location

Clinical Research Site #840-032

Miami, Florida, 33122, United States

Location

Clinical Research Site #840-080

Miami, Florida, 33173, United States

Location

Clinical Research Site #840-084

Miami Lakes, Florida, 33014, United States

Location

Clinical Research Site

Okeechobee, Florida, 34972, United States

Location

Clinical Research Site # 840-102

Weston, Florida, 33331, United States

Location

Clinical Research Site #840-088

Atlanta, Georgia, 30303, United States

Location

Clinical Research Site #840-091

Atlanta, Georgia, 30318, United States

Location

Clinical Research Site #840-008

Atlanta, Georgia, 30328, United States

Location

Clinical Research Site #840-063

Decatur, Georgia, 30030, United States

Location

Clinical Research Site

Chicago, Illinois, 60640, United States

Location

Clinical Research Site #840-090

Springfield, Illinois, 62702, United States

Location

Clinical Research Site

Lake Charles, Louisiana, 70629, United States

Location

Clinical Research Site #840-098

Shreveport, Louisiana, 71101, United States

Location

Clinical Research Site #840-072

Worcester, Massachusetts, 01605, United States

Location

Clinical Research Site #840-057

Flowood, Mississippi, 39232, United States

Location

Clinical Research Site #840-040

Olivette, Missouri, 63132, United States

Location

Clinical Research Site #840-029

Saint Charles, Missouri, 63304, United States

Location

Clinical Research Site #840-034

Saint Charles, Missouri, 63304, United States

Location

Clinical Research Site

St Louis, Missouri, 63109, United States

Location

Clinical Research Site #840-025

St Louis, Missouri, 63118, United States

Location

Clinical Research Site #840-028

Berlin, New Jersey, 08009, United States

Location

Clinical Research Site #840-009

Jamaica, New York, 11432, United States

Location

Clinical Research Site #840-070

New York, New York, 10027, United States

Location

Clinical Research Site

Rochester, New York, 14618, United States

Location

Clinical Research Site #840-074

Charlotte, North Carolina, 28211, United States

Location

Clinical Research Site #840-052

Middleburg Heights, Ohio, 44130, United States

Location

Clinical Research Site

Edmond, Oklahoma, 73013, United States

Location

Clinical Research Site #840-065

Oklahoma City, Oklahoma, 73112, United States

Location

Clinical Research Site #840-061

Media, Pennsylvania, 19063, United States

Location

Clinical Research Site

Norristown, Pennsylvania, 19401, United States

Location

Clinical Research Site #840-099

Myrtle Beach, South Carolina, 28117, United States

Location

Clinical Research Site

Memphis, Tennessee, 38119, United States

Location

Clinical Research Site

DeSoto, Texas, 75115, United States

Location

Clinical Research Site #840-058

Fort Worth, Texas, 76104, United States

Location

Clinical Research Site #840-018

Richardson, Texas, 75080, United States

Location

Clinical Research Site

San Antonio, Texas, 78229, United States

Location

Clinical Research Site #840-069

Springville, Utah, 84663, United States

Location

Clinical Research Site #840-051

Everett, Washington, 98201, United States

Location

Clinical Research Site #009

Kazanlak, 6100, Bulgaria

Location

Clinical Research Site #100-008

Novi Iskar, 1282, Bulgaria

Location

Clinical Research Site #100-007

Plovdiv, 4004, Bulgaria

Location

Clinical Research Site #100-004 2

Sofia, 1680, Bulgaria

Location

Clinical Research Site #100-006

Veliko Tarnovo, 5000, Bulgaria

Location

Clinical Research Site #100-001

Vratsa, 3000, Bulgaria

Location

Clinical Research Site

Tuszyn, Woj.Iodzkie, 95-080, Poland

Location

Clinical Research Site #616-002

Bełchatów, 97-400, Poland

Location

Clinical Research Site #616-003

Pruszcz Gdański, 80-300, Poland

Location

Clinical Research Site #630-001

San Juan, 918, Puerto Rico

Location

Clinical Research Site # 630-002

San Juan, 926, Puerto Rico

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: April 1, 2019
• Study Start: February 15, 2019
• Primary Completion: May 23, 2023
• Study Completion: May 23, 2023
• Last Updated: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
• Access Criteria: Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/

Locations

US (61); PR (2); PL (3); BU (6)