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

Primary Purpose

Schizophrenia

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
AVP-786
Sponsored by
Otsuka Pharmaceutical Development & Commercialization, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Negative Symptoms, Schizophrenia, AVP-786

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Research Site
  • Clinical Research Site #840-041
  • Clinical Research Site #840-013
  • Clinical Research Site #840-079
  • Clinical Research Site #840-027
  • Clinical Research Site #840-006
  • Clinical Research Site #840-026
  • Clinical Research Site# 840-067
  • Clinical Research Site# 840-083
  • Clinical Research Site 840-002
  • Clinical Research Site
  • Clinical Research Site #840-035
  • Clinical Research Site# 840-010
  • Clinical Research Site #840-012
  • Clinical Research Site# 840-081
  • Clinical Research Site
  • Clinical Research Site #840-096
  • Clinical Research Site #840-015
  • Clinical Research Site# 840-094
  • Clinical Research Site #840-046
  • Clinical Research Site Site #840-093
  • Clinical Research Site #840-062
  • Clinical Research Site #840-024
  • Clinical Research Site #840-084
  • Clinical Research Site #840-032
  • Clinical Research Site #840-080
  • Clinical Research Site
  • Clinical Research Site # 840-102
  • Clinical Research Site #840-088
  • Clinical Research Site #840-091
  • Clinical Research Site #840-008
  • Clinical Research Site #840-063
  • Clinical Research Site
  • Clinical Research Site #840-090
  • Clinical Research Site
  • Clinical Research Site #840-098
  • Clinical Research Site #840-072
  • Clinical Research Site #840-057
  • Clinical Research Site #840-040
  • Clinical Research Site #840-029
  • Clinical Research Site #840-034
  • Clinical Research Site
  • Clinical Research Site #840-025
  • Clinical Research Site #840-028
  • Clinical Research Site #840-009
  • Clinical Research Site #840-070
  • Clinical Research Site
  • Clinical Research Site #840-074
  • Clinical Research Site #840-052
  • Clinical Research Site
  • Clinical Research Site #840-065
  • Clinical Research Site #840-061
  • Clinical Research Site
  • Clinical Research Site #840-099
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site #840-058
  • Clinical Research Site #840-018
  • Clinical Research Site
  • Clinical Research Site #840-069
  • Clinical Research Site #840-051
  • Clinical Research Site #009
  • Clinical Research Site
  • Clinical Research Site #007
  • Clinical Research Site 2
  • Clinical Research Site
  • Clinical Research Site #001
  • Clinical Research Site #348-001
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site #630-001
  • Clinical Research Site no. 630-002

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

AVP-786

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from Baseline to Week 15 in the Negative Symptom Assessment-16 (NSA-16) Global Negative Symptom Score
Change from Baseline to Week 15 in the Patient Global Impression of Severity (PGI-S) Score
Change from Baseline to Week 15 in the Patient Global Impression of Change (PGI-C) Score

Full Information

First Posted
March 19, 2019
Last Updated
October 20, 2023
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03896945
Brief Title
Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Negative Symptoms of Schizophrenia
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
Based on the Interim Analysis outcome and recommendation by the DMC, Otsuka approved termination of the study based on futility.
Study Start Date
February 15, 2019 (Actual)
Primary Completion Date
May 23, 2023 (Actual)
Study Completion Date
May 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Negative Symptoms, Schizophrenia, AVP-786

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsules will be administered orally twice a day over a 15-week period.
Arm Title
AVP-786
Arm Type
Experimental
Arm Description
AVP-786 capsules will be administered orally twice a day over a 15-week period.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral capsules
Intervention Type
Drug
Intervention Name(s)
AVP-786
Intervention Description
oral capsules
Primary Outcome Measure Information:
Title
Change from Baseline to Week 15 in the Positive and Negative Syndrome Scale (PANSS) Marder Negative Factors Score
Time Frame
Baseline; Week 15
Secondary Outcome Measure Information:
Title
Change from Baseline to Week 15 in the Negative Symptom Assessment-16 (NSA-16) Global Negative Symptom Score
Time Frame
Baseline; Week 15
Title
Change from Baseline to Week 15 in the Patient Global Impression of Severity (PGI-S) Score
Time Frame
Baseline; Week 15
Title
Change from Baseline to Week 15 in the Patient Global Impression of Change (PGI-C) Score
Time Frame
Baseline; Week 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Clinical Research Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72209
Country
United States
Facility Name
Clinical Research Site #840-041
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
Clinical Research Site #840-013
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
Facility Name
Clinical Research Site #840-079
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Clinical Research Site #840-027
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Facility Name
Clinical Research Site #840-006
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Clinical Research Site #840-026
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Clinical Research Site# 840-067
City
La Habra
State/Province
California
ZIP/Postal Code
90631
Country
United States
Facility Name
Clinical Research Site# 840-083
City
Lafayette
State/Province
California
ZIP/Postal Code
94549
Country
United States
Facility Name
Clinical Research Site 840-002
City
Lemon Grove
State/Province
California
ZIP/Postal Code
91945
Country
United States
Facility Name
Clinical Research Site
City
Oakland
State/Province
California
ZIP/Postal Code
94607
Country
United States
Facility Name
Clinical Research Site #840-035
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Clinical Research Site# 840-010
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Facility Name
Clinical Research Site #840-012
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
Clinical Research Site# 840-081
City
San Bernardino
State/Province
California
ZIP/Postal Code
92408
Country
United States
Facility Name
Clinical Research Site
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States
Facility Name
Clinical Research Site #840-096
City
Santee
State/Province
California
ZIP/Postal Code
92071
Country
United States
Facility Name
Clinical Research Site #840-015
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Clinical Research Site# 840-094
City
Doral
State/Province
Florida
ZIP/Postal Code
33178
Country
United States
Facility Name
Clinical Research Site #840-046
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Clinical Research Site Site #840-093
City
Homestead
State/Province
Florida
ZIP/Postal Code
33030
Country
United States
Facility Name
Clinical Research Site #840-062
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33803
Country
United States
Facility Name
Clinical Research Site #840-024
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Facility Name
Clinical Research Site #840-084
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Clinical Research Site #840-032
City
Miami
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Facility Name
Clinical Research Site #840-080
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Clinical Research Site
City
Okeechobee
State/Province
Florida
ZIP/Postal Code
34972
Country
United States
Facility Name
Clinical Research Site # 840-102
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Clinical Research Site #840-088
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Clinical Research Site #840-091
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
Clinical Research Site #840-008
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Clinical Research Site #840-063
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Clinical Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Clinical Research Site #840-090
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Clinical Research Site
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70629
Country
United States
Facility Name
Clinical Research Site #840-098
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Clinical Research Site #840-072
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Clinical Research Site #840-057
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Clinical Research Site #840-040
City
Olivette
State/Province
Missouri
ZIP/Postal Code
63132
Country
United States
Facility Name
Clinical Research Site #840-029
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63304
Country
United States
Facility Name
Clinical Research Site #840-034
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63304
Country
United States
Facility Name
Clinical Research Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63109
Country
United States
Facility Name
Clinical Research Site #840-025
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63118
Country
United States
Facility Name
Clinical Research Site #840-028
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Clinical Research Site #840-009
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Facility Name
Clinical Research Site #840-070
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States
Facility Name
Clinical Research Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Clinical Research Site #840-074
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Clinical Research Site #840-052
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Clinical Research Site
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73013
Country
United States
Facility Name
Clinical Research Site #840-065
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Clinical Research Site #840-061
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
Clinical Research Site
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19401
Country
United States
Facility Name
Clinical Research Site #840-099
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
28117
Country
United States
Facility Name
Clinical Research Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Clinical Research Site
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
Clinical Research Site #840-058
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Clinical Research Site #840-018
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
Facility Name
Clinical Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Clinical Research Site #840-069
City
Springville
State/Province
Utah
ZIP/Postal Code
84663
Country
United States
Facility Name
Clinical Research Site #840-051
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Clinical Research Site #009
City
Kazanlak
ZIP/Postal Code
6100
Country
Bulgaria
Facility Name
Clinical Research Site
City
Novi Iskar
ZIP/Postal Code
1282
Country
Bulgaria
Facility Name
Clinical Research Site #007
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Facility Name
Clinical Research Site 2
City
Sofia
ZIP/Postal Code
1680
Country
Bulgaria
Facility Name
Clinical Research Site
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Facility Name
Clinical Research Site #001
City
Vratsa
ZIP/Postal Code
3000
Country
Bulgaria
Facility Name
Clinical Research Site #348-001
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Clinical Research Site
City
Tuszyn
State/Province
Woj.Iodzkie
ZIP/Postal Code
95-080
Country
Poland
Facility Name
Clinical Research Site
City
Bełchatów
ZIP/Postal Code
97-400
Country
Poland
Facility Name
Clinical Research Site
City
Pruszcz Gdański
ZIP/Postal Code
80-300
Country
Poland
Facility Name
Clinical Research Site #630-001
City
San Juan
ZIP/Postal Code
918
Country
Puerto Rico
Facility Name
Clinical Research Site no. 630-002
City
San Juan
ZIP/Postal Code
926
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://clinical-trials.otsuka.com

Learn more about this trial

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

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