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

Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03896945
Collaborator
(none)
370
82
2
68.5
4.5
0.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
370 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Feb 15, 2019
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Nov 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline to Week 15 in the Positive and Negative Syndrome Scale (PANSS) Marder Negative Factors Score [Baseline; Week 15]

Secondary Outcome Measures

  1. Change from Baseline to Week 15 in the Negative Symptom Assessment-16 (NSA-16) Global Negative Symptom Score [Baseline; Week 15]

  2. Change from Baseline to Week 15 in the Patient Global Impression of Severity (PGI-S) Score [Baseline; Week 15]

  3. Change from Baseline to Week 15 in the Patient Global Impression of Change (PGI-C) Score [Baseline; Week 15]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinical Research Site Little Rock Arkansas United States 72209
2 Clinical Research Site Rogers Arkansas United States 72758
3 Clinical Research Site Anaheim California United States 92805
4 Clinical Research Site Bellflower California United States 90706
5 Clinical Research Site Costa Mesa California United States 92626
6 Clinical Research Site Culver City California United States 90230
7 Clinical Research Site Garden Grove California United States 92845
8 Clinical Research Site Glendale California United States 91206
9 Clinical Research Site La Habra California United States 90631
10 Clinical Research Site Lafayette California United States 94549
11 Clinical Research Site Lemon Grove California United States 91945
12 Clinical Research Site Oakland California United States 94607
13 Clinical Research Site Oceanside California United States 92056
14 Clinical Research Site Panorama City California United States 91402
15 Clinical Research Site Riverside California United States 92506
16 Clinical Research Site San Bernardino California United States 92408
17 Clinical Research Site San Diego California United States 92102
18 Clinical Research Site San Diego California United States 92103
19 Clinical Research Site #840-096 Santee California United States 92071
20 Clinical Research Site Torrance California United States 90502
21 Clinical Research Site Doral Florida United States 33178
22 Clinical Research Site Hollywood Florida United States 33021
23 Clinical Research Site Homestead Florida United States 33030
24 Clinical Research Site Jupiter Florida United States 33458
25 Clinical Research Site Lakeland Florida United States 33803
26 Clinical Research Site Largo Florida United States 33770
27 Clinical Research Site #840-084 Miami Lakes Florida United States 33014
28 Clinical Research Site Miami Florida United States 33122
29 Clinical Research Site Miami Florida United States 33135
30 Clinical Research Site Miami Florida United States 33173
31 Clinical Research Site Okeechobee Florida United States 34972
32 Clinical Research Site Orange City Florida United States 32763
33 Clinical Research Site Tampa Florida United States 33613
34 Clinical Research Site Atlanta Georgia United States 30303
35 Clinical Research Site Atlanta Georgia United States 30318
36 Clinical Research Site Atlanta Georgia United States 30328
37 Clinical Research Site Decatur Georgia United States 30030
38 Clinical Research Site Chicago Illinois United States 60640
39 Clinical Research Site Lincolnwood Illinois United States 60712
40 Clinical Research Site Springfield Illinois United States 62702
41 Clinical Research Site Lake Charles Louisiana United States 70629
42 Clinical Research Site Boston Massachusetts United States 02114
43 Clinical Research Site Springfield Massachusetts United States 01103
44 Clinical Research Site #840-072 Worcester Massachusetts United States 01605
45 Clinical Research Site Flowood Mississippi United States 39232
46 Clinical Research Site Olivette Missouri United States 63132
47 Clinical Research Site 1 Saint Charles Missouri United States 63304
48 Clinical Research Site 2 Saint Charles Missouri United States 63304
49 Clinical Research Site Saint Louis Missouri United States 63109
50 Clinical Research Site Saint Louis Missouri United States 63118
51 Clinical Research Site Berlin New Jersey United States 08009
52 Clinical Research Site Jamaica New York United States 11432
53 Clinical Research Site New York New York United States 10016
54 Clinical Research Site New York New York United States 10027
55 Clinical Research Site Rochester New York United States 14618
56 Clinical Research Site #840-074 Charlotte North Carolina United States 28211
57 Clinical Research Site Dayton Ohio United States 45417
58 Clinical Research Site Middleburg Heights Ohio United States 44130
59 Clinical Research Site Edmond Oklahoma United States 73013
60 Clinical Research Site Oklahoma City Oklahoma United States 73112
61 Clinical Research Site Media Pennsylvania United States 19063
62 Clinical Research Site Norristown Pennsylvania United States 19401
63 Clinical Research Site Memphis Tennessee United States 38119
64 Clinical Research Site DeSoto Texas United States 75115
65 Clinical Research Site Fort Worth Texas United States 76104
66 Clinical Research Site Richardson Texas United States 75080
67 Clinical Research Site Richmond Texas United States 77407
68 Clinical Research Site San Antonio Texas United States 78229
69 Clinical Research Site Springville Utah United States 84663
70 Clinical Research Site Everett Washington United States 98201
71 Clinical Research Site #009 Kazanlak Bulgaria 6100
72 Clinical Research Site Novi Iskar Bulgaria 1282
73 Clinical Research Site #007 Plovdiv Bulgaria 4004
74 Clinical Research Site 1 Sofia Bulgaria 1680
75 Clinical Research Site 2 Sofia Bulgaria 1680
76 Clinical Research Site Veliko Tarnovo Bulgaria 5000
77 Clinical Research Site #001 Vratsa Bulgaria 3000
78 Clinical Research Site Tuszyn Woj.Iodzkie Poland 95-080
79 Clinical Research Site Bełchatów Poland 97-400
80 Clinical Research Site Pruszcz Gdański Poland 80-300
81 Clinical Research Site #630-001 San Juan Puerto Rico 918
82 Clinical Research Site no. 630-002 San Juan Puerto Rico 926

Sponsors and Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT03896945
Other Study ID Numbers:
  • 18-AVP-786-207
  • 2021-001352-33
First Posted:
Apr 1, 2019
Last Update Posted:
Aug 24, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 24, 2022