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

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Negative Symptoms of Schizophrenia

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.

Study Overview

• Status: Terminated
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Placebo; Drug: AVP-786

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Kazanlak, Bulgaria, 6100
    • Clinical Research Site #009
  • Novi Iskar, Bulgaria, 1282
    • Clinical Research Site #100-008
  • Plovdiv, Bulgaria, 4004
    • Clinical Research Site #100-007
  • Sofia, Bulgaria, 1680
    • Clinical Research Site #100-004 2
  • Veliko Tarnovo, Bulgaria, 5000
    • Clinical Research Site #100-006
  • Vratsa, Bulgaria, 3000
    • Clinical Research Site #100-001
• Poland
  • Bełchatów, Poland, 97-400
    • Clinical Research Site #616-002
  • Pruszcz Gdański, Poland, 80-300
    • Clinical Research Site #616-003
  • Woj.Iodzkie
    • Tuszyn, Woj.Iodzkie, Poland, 95-080
      • Clinical Research Site
• Puerto Rico
  • San Juan, Puerto Rico, 918
    • Clinical Research Site #630-001
  • San Juan, Puerto Rico, 926
    • Clinical Research Site # 630-002
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72209
      • Clinical Research Site
  • California
    • Anaheim, California, United States, 92805
      • Clinical Research Site #840-041
    • Bellflower, California, United States, 90706
      • Clinical Research Site #840-013
    • Costa Mesa, California, United States, 92626
      • Clinical Research Site #840-079
    • Culver City, California, United States, 90230
      • Clinical Research Site #840-027
    • Garden Grove, California, United States, 92845
      • Clinical Research Site #840-006
    • Glendale, California, United States, 91206
      • Clinical Research Site #840-026
    • La Habra, California, United States, 90631
      • Clinical Research Site# 840-067
    • Lafayette, California, United States, 94549
      • Clinical Research Site# 840-083
    • Lemon Grove, California, United States, 91945
      • Clinical Research Site 840-002
    • Oakland, California, United States, 94607
      • Clinical Research Site
    • Oceanside, California, United States, 92056
      • Clinical Research Site #840-035
    • Panorama City, California, United States, 91402
      • Clinical Research Site# 840-010
    • Riverside, California, United States, 92506
      • Clinical Research Site #840-012
    • San Bernardino, California, United States, 92408
      • Clinical Research Site# 840-081
    • San Diego, California, United States, 92102
      • Clinical Research Site #840-005
    • Santee, California, United States, 92071
      • Clinical Research Site #840-096
    • Torrance, California, United States, 90502
      • Clinical Research Site #840-015
  • Florida
    • Doral, Florida, United States, 33178
      • Clinical Research Site# 840-094
    • Hollywood, Florida, United States, 33021
      • Clinical Research Site #840-046
    • Homestead, Florida, United States, 33030
      • Clinical Research Site Site #840-093
    • Lakeland, Florida, United States, 33803
      • Clinical Research Site #840-062
    • Largo, Florida, United States, 33770
      • Clinical Research Site #840-024
    • Miami, Florida, United States, 33122
      • Clinical Research Site #840-032
    • Miami, Florida, United States, 33173
      • Clinical Research Site #840-080
    • Miami Lakes, Florida, United States, 33014
      • Clinical Research Site #840-084
    • Okeechobee, Florida, United States, 34972
      • Clinical Research Site
    • Weston, Florida, United States, 33331
      • Clinical Research Site # 840-102
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Clinical Research Site #840-088
    • Atlanta, Georgia, United States, 30318
      • Clinical Research Site #840-091
    • Atlanta, Georgia, United States, 30328
      • Clinical Research Site #840-008
    • Decatur, Georgia, United States, 30030
      • Clinical Research Site #840-063
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Clinical Research Site
    • Springfield, Illinois, United States, 62702
      • Clinical Research Site #840-090
  • Louisiana
    • Lake Charles, Louisiana, United States, 70629
      • Clinical Research Site
    • Shreveport, Louisiana, United States, 71101
      • Clinical Research Site #840-098
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • Clinical Research Site #840-072
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Clinical Research Site #840-057
  • Missouri
    • Olivette, Missouri, United States, 63132
      • Clinical Research Site #840-040
    • Saint Charles, Missouri, United States, 63304
      • Clinical Research Site #840-029
    • Saint Charles, Missouri, United States, 63304
      • Clinical Research Site #840-034
    • Saint Louis, Missouri, United States, 63109
      • Clinical Research Site
    • Saint Louis, Missouri, United States, 63118
      • Clinical Research Site #840-025
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Clinical Research Site #840-028
  • New York
    • Jamaica, New York, United States, 11432
      • Clinical Research Site #840-009
    • New York, New York, United States, 10027
      • Clinical Research Site #840-070
    • Rochester, New York, United States, 14618
      • Clinical Research Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28211
      • Clinical Research Site #840-074
  • Ohio
    • Middleburg Heights, Ohio, United States, 44130
      • Clinical Research Site #840-052
  • Oklahoma
    • Edmond, Oklahoma, United States, 73013
      • Clinical Research Site
    • Oklahoma City, Oklahoma, United States, 73112
      • Clinical Research Site #840-065
  • Pennsylvania
    • Media, Pennsylvania, United States, 19063
      • Clinical Research Site #840-061
    • Norristown, Pennsylvania, United States, 19401
      • Clinical Research Site
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 28117
      • Clinical Research Site #840-099
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Clinical Research Site
  • Texas
    • DeSoto, Texas, United States, 75115
      • Clinical Research Site
    • Fort Worth, Texas, United States, 76104
      • Clinical Research Site #840-058
    • Richardson, Texas, United States, 75080
      • Clinical Research Site #840-018
    • San Antonio, Texas, United States, 78229
      • Clinical Research Site
  • Utah
    • Springville, Utah, United States, 84663
      • Clinical Research Site #840-069
  • Washington
    • Everett, Washington, United States, 98201
      • Clinical Research Site #840-051

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo capsules will be administered orally twice a day over a 15-week period.	Drug: Placebo; oral capsules
Experimental: AVP-786; AVP-786 capsules will be administered orally twice a day over a 15-week period.	Drug: AVP-786; oral capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline to Week 15 in the Positive and Negative Syndrome Scale (PANSS) Marder Negative Factors Score	Baseline; Week 15

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2019
• Primary Completion (Actual): May 23, 2023
• Study Completion (Actual): May 23, 2023

Study Registration Dates

• First Submitted: March 19, 2019
• First Submitted That Met QC Criteria: March 28, 2019
• First Posted (Actual): April 1, 2019

Study Record Updates

• Last Update Posted (Actual): May 24, 2024
• Last Update Submitted That Met QC Criteria: May 21, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Schizophrenia; Negative Symptoms; AVP-786
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: 18-AVP-786-207; 2021-001352-33 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
• IPD Sharing 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.
• IPD Sharing Access Criteria: Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No