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Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Neurobehavioral Disinhibition Including Aggression, Agitation, and Irritability in Participants With Traumatic Brain Injury

Primary Purpose

Neurobehavioral Disinhibition

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
AVP-786-28
AVP-786-42.63
Sponsored by
Otsuka Pharmaceutical Development & Commercialization, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurobehavioral Disinhibition focused on measuring aggression, agitation, irritability, non-penetrating brain injury, traumatic brain injury, TBI, AVP-786

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants with traumatic brain injury (TBI)
  • Participants with neurobehavioral disinhibition symptoms that are present after trauma or after recovery of consciousness
  • Score of ≥4 on the modified Clinical Global Impression of Severity (mCGI-S) scale and the Agitation/Aggression or Irritability/Lability subscales of the Neuropsychiatric Inventory (NPI) scale at screening and baseline
  • Participants with a reliable caregiver

Exclusion Criteria:

  • Participants with significant symptoms of a major depressive disorder
  • Participants with a history of or current clinical symptoms of schizophrenia, schizoaffective disorder, bipolar disorder, antisocial personality disorder, or borderline personality disorder

Sites / Locations

  • Tuscaloosa Veterans Affairs Medical Center
  • Absolute Clinical Research Site#207
  • Perseverance Research Center Site#152
  • ATP Clinical Research Site#150
  • Kaizen Brain Center #224
  • Sunwise Clinical Research, LLC Site#216
  • Torrance Clinical Research Institute Site#157
  • Tibor Rubin VA Medical Center, SCIRE Biomedical Research Institute
  • Asclepes Research Centers - Panorama City Site #208
  • The Neurology Group
  • Mountain Mind
  • Mountain View Clinical Research, Inc. Site# 202
  • Medical Center of the Rockies
  • Connecticut Clinical Research
  • Bradenton Research Center, Inc
  • Healthcare Innovative Institute, LLC Site# 173
  • Science Connections, LLC Site#161
  • Design Neuroscience Center, PL
  • Alphab Global Research Site#163
  • Meridien Research
  • Premier Clinical Research Institute, Inc.
  • Project 4 Research
  • Allied Biomedical Research Institute, Inc. Site#151
  • Health Synergy Clinical Research
  • Roskamp Institute Clinic, Inc.
  • USF Dept of Psychiatry and Behavioral Neurosciences Site# 214
  • Meridien Research Site# 108
  • Hawaii Pacific Neuroscience Site#184
  • The University of Kentucky research foundation
  • Baptist Health
  • Sisu BHR Site#200
  • Neurobehavioral Medicine Group #222
  • Millennium Psychiatric Associates, LLC
  • Sharlin Health and Neurology
  • Clinical Research Professionals
  • JFK Johnson Rehabilitation Institute
  • The NeuroCognitive Insititute
  • New York University School of Medicine Site #122
  • Atrium Health - Carolinas Rehabilitation - Charlotte Site #166
  • New Hope Clinical Research Site#194
  • Carolina Headache Institute
  • Salisbury VAMC
  • Valley Medical Research
  • Cincinnati VA Medical Center
  • North Star Medical Research, LLC Site#154
  • IPS Research Site#196
  • University of Pittsburgh
  • WJB Dorn VA-Wm. Jennings Bryan Dorn VA Medical Center
  • University of Texas Southwestern Medical Site#140
  • Polytrauma Rehabilitation Center S. Texas VA Health Care System Site# 146
  • Cedar Clinical Research #221
  • Virginia Commonwealth University #172
  • Virginia Commonwealth University Site#172
  • Salem Research Institute Site# 138

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

Stage 1: Placebo

AVP-786

Stage 1: Placebo Non-responders to Stage 2: Placebo

Stage 1: Placebo Non-responders to Stage 2: AVP-786

Stage 1: Placebo Responders to Stage 2: Placebo

Stage 1: Placebo Responders to Stage 2: AVP-786

Arm Description

Participants will receive AVP-786 matching placebo capsules, orally, twice daily (BID) during Weeks 1 to 6 of the Stage 1 treatment period.

Participants will receive AVP-786-28/4.9 (deudextromethorpan hydrobromide [d6-DM] 28 milligrams (mg)/quinidine sulfate [Q] 4.9 mg) capsule, along with AVP-786 matching placebo capsule, orally, once daily (QD) during Week 1 followed by AVP-786-28/4.9 capsule, orally, BID during Week 2, and AVP-786-42.63/4.9 (d6-DM 42.63 mg/Q 4.9 mg) capsules (target dose), orally, BID during Weeks 3 to 12 of the treatment period.

Participants who will be randomized to receive placebo in Stage 1 and will be classified as non-responders (responders" if modified Clinical Global Impression of Severity [mCGI-S] score is ≤ 3 at Day 43 and Neuropsychiatric Inventory Clinician (NPI-C)-3 score has decreased by ≥ 25% from baseline. Participants who will not meet these criteria will be considered "non-responders) after Week 6 will be re-randomized to continue receiving AVP-786 matching placebo capsules, orally, BID during Weeks 7 to 12 of the Stage 2 treatment period.

Participants who will be randomized randomized to receive placebo in Stage 1 and will be classified as non-responders (responders" if mCGI-S score is ≤ 3 at Day 43 and NPI-C-3 score has decreased by ≥ 25% from baseline. Participants who will not meet these criteria will be considered "non-responders) after Week 6 will be re-randomized to receive AVP-786 in Stage 2 using the same dose escalation schedule used in Stage 1 i.e., AVP-786-28/4.9 capsule, along with AVP-786 matching placebo capsule, orally, QD during Week 7 followed by AVP-786-28/4.9 capsule, orally, BID during Week 8, and AVP-786-42.63/4.9 capsules, orally, BID, during Weeks 9 to 12 of the Stage 2 treatment period.

Participants who will be randomized to receive placebo in Stage 1 and will be classified as responders (responders" if mCGI-S score is ≤ 3 at Day 43 and NPI-C-3 score has decreased by ≥ 25% from baseline) after Week 6 will be re-randomized to continue receiving AVP-786 matching placebo capsules, orally, BID during Weeks 7 to 12 of the Stage 2 treatment period.

Participants who will be randomized to receive placebo in Stage 1 and will be classified as responders (responders" if mCGI-S score is ≤ 3 at Day 43 and NPI-C-3 score has decreased by ≥ 25% from baseline) after Week 6 will be re-randomized to receive AVP-786 in Stage 2 using the same dose escalation schedule used in Stage 1 i.e., AVP-786-28/4.9 capsule, along with AVP-786 matching placebo capsule, orally, QD during Week 7 followed by AVP-786-28/4.9 capsule, orally, BID during Week 8, and AVP-786-42.63/4.9 capsules, orally, BID, during Weeks 9 to 12 of the Stage 2 treatment period.

Outcomes

Primary Outcome Measures

Change from Baseline to Week 12 in the Composite of the Clinical Impression Severity Scores on the Neuropsychiatric Inventory Clinician Rating Scale (NPI-C) Subscales of Aggression, Agitation, and Irritability/Lability (NPI-C-3)
The NPI-C can be used to rate the presence of neuropsychiatric symptoms across 14 domains. The scores for each item within an individual domain/subscale range from 0 to 3, with a higher score indicating increased severity. The NPI-C-3 is comprised of the aggression, agitation, and irritability/lability subscales. The scores for the three subscales are summed to create the total NPI-C-3 composite score, which ranges from 0 to 99, with a higher score indicating increased severity.

Secondary Outcome Measures

Change from Baseline to Week 12 in Modified Clinical Global Impression of Change (mCGI-C) Raw Scores
The mCGI-C will be used to assess the clinician's general impression of the participant's treatment response. The mCGI-C is a 7-point (1 to 7) modified version of the CGI-C scale. A higher score represents worsening of symptoms.
Change from Baseline to Week 12 in NPI-C Rating Scale Subscales Scores for Aggression, Agitation, Irritability/Lability, and Disinhibition
The NPI-C is used to rate the presence of neuropsychiatric symptoms across 14 domains. The scores for each item within an individual domain/subscale range from 0 to 3, with a higher score indicating increased severity.
Change from Baseline to Week 12 in Modified Clinical Global Impression of Severity (mCGI-S) Scale Scores
The mCGI-S will be used to assess the clinician's view of the participant's severity of aggression, agitation, and irritability symptoms. The mCGI-S is a 7-point (1 to 7) modified version of the CGI-S scale. In all cases, a higher score represents increased severity.
Change from Baseline to Week 12 in Patient Global Impression of Severity (PGI-S) Scores
The PGI-S is a single-question scale that specifically assesses the severity of symptoms of neurobehavioral disinhibition, including aggression, agitation, and irritability, on a 7-point scale : 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.
Change from Baseline to Week 12 in Patient Global Impression of Change (PGI-C) Raw Scores
The PGI-C is a 7-point (1 to 7) scale used to assess the participant's assessment of treatment response. A higher score indicates worsening of the symptoms.

Full Information

First Posted
March 23, 2017
Last Updated
September 26, 2023
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03095066
Brief Title
Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Neurobehavioral Disinhibition Including Aggression, Agitation, and Irritability in Participants With Traumatic Brain Injury
Official Title
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Neurobehavioral Disinhibition Including Aggression, Agitation, and Irritability in Patients With Traumatic Brain Injury (TBI).
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 30, 2017 (Actual)
Primary Completion Date
August 22, 2022 (Actual)
Study Completion Date
August 31, 2022 (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
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a multicenter, randomized, placebo-controlled study to evaluate AVP-786 for the treatment of neurobehavioral disinhibition including aggression, agitation, and irritability in participants with traumatic brain injury (TBI).
Detailed Description
Eligible participants for this study must have a diagnosis of neurobehavioral disinhibition including aggression, agitation, and irritability that persists after brain injury. This is a multicenter, randomized, placebo-controlled study, consisting of up to 12 weeks of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurobehavioral Disinhibition
Keywords
aggression, agitation, irritability, non-penetrating brain injury, traumatic brain injury, TBI, AVP-786

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Stage 1: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive AVP-786 matching placebo capsules, orally, twice daily (BID) during Weeks 1 to 6 of the Stage 1 treatment period.
Arm Title
AVP-786
Arm Type
Experimental
Arm Description
Participants will receive AVP-786-28/4.9 (deudextromethorpan hydrobromide [d6-DM] 28 milligrams (mg)/quinidine sulfate [Q] 4.9 mg) capsule, along with AVP-786 matching placebo capsule, orally, once daily (QD) during Week 1 followed by AVP-786-28/4.9 capsule, orally, BID during Week 2, and AVP-786-42.63/4.9 (d6-DM 42.63 mg/Q 4.9 mg) capsules (target dose), orally, BID during Weeks 3 to 12 of the treatment period.
Arm Title
Stage 1: Placebo Non-responders to Stage 2: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants who will be randomized to receive placebo in Stage 1 and will be classified as non-responders (responders" if modified Clinical Global Impression of Severity [mCGI-S] score is ≤ 3 at Day 43 and Neuropsychiatric Inventory Clinician (NPI-C)-3 score has decreased by ≥ 25% from baseline. Participants who will not meet these criteria will be considered "non-responders) after Week 6 will be re-randomized to continue receiving AVP-786 matching placebo capsules, orally, BID during Weeks 7 to 12 of the Stage 2 treatment period.
Arm Title
Stage 1: Placebo Non-responders to Stage 2: AVP-786
Arm Type
Experimental
Arm Description
Participants who will be randomized randomized to receive placebo in Stage 1 and will be classified as non-responders (responders" if mCGI-S score is ≤ 3 at Day 43 and NPI-C-3 score has decreased by ≥ 25% from baseline. Participants who will not meet these criteria will be considered "non-responders) after Week 6 will be re-randomized to receive AVP-786 in Stage 2 using the same dose escalation schedule used in Stage 1 i.e., AVP-786-28/4.9 capsule, along with AVP-786 matching placebo capsule, orally, QD during Week 7 followed by AVP-786-28/4.9 capsule, orally, BID during Week 8, and AVP-786-42.63/4.9 capsules, orally, BID, during Weeks 9 to 12 of the Stage 2 treatment period.
Arm Title
Stage 1: Placebo Responders to Stage 2: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants who will be randomized to receive placebo in Stage 1 and will be classified as responders (responders" if mCGI-S score is ≤ 3 at Day 43 and NPI-C-3 score has decreased by ≥ 25% from baseline) after Week 6 will be re-randomized to continue receiving AVP-786 matching placebo capsules, orally, BID during Weeks 7 to 12 of the Stage 2 treatment period.
Arm Title
Stage 1: Placebo Responders to Stage 2: AVP-786
Arm Type
Experimental
Arm Description
Participants who will be randomized to receive placebo in Stage 1 and will be classified as responders (responders" if mCGI-S score is ≤ 3 at Day 43 and NPI-C-3 score has decreased by ≥ 25% from baseline) after Week 6 will be re-randomized to receive AVP-786 in Stage 2 using the same dose escalation schedule used in Stage 1 i.e., AVP-786-28/4.9 capsule, along with AVP-786 matching placebo capsule, orally, QD during Week 7 followed by AVP-786-28/4.9 capsule, orally, BID during Week 8, and AVP-786-42.63/4.9 capsules, orally, BID, during Weeks 9 to 12 of the Stage 2 treatment period.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered as capsules
Intervention Type
Drug
Intervention Name(s)
AVP-786-28
Intervention Description
28 mg of d6-DM and 4.9 mg of Q
Intervention Type
Drug
Intervention Name(s)
AVP-786-42.63
Intervention Description
42.63 mg of d6-DM and 4.9 mg of Q
Primary Outcome Measure Information:
Title
Change from Baseline to Week 12 in the Composite of the Clinical Impression Severity Scores on the Neuropsychiatric Inventory Clinician Rating Scale (NPI-C) Subscales of Aggression, Agitation, and Irritability/Lability (NPI-C-3)
Description
The NPI-C can be used to rate the presence of neuropsychiatric symptoms across 14 domains. The scores for each item within an individual domain/subscale range from 0 to 3, with a higher score indicating increased severity. The NPI-C-3 is comprised of the aggression, agitation, and irritability/lability subscales. The scores for the three subscales are summed to create the total NPI-C-3 composite score, which ranges from 0 to 99, with a higher score indicating increased severity.
Time Frame
Baseline; Week 12
Secondary Outcome Measure Information:
Title
Change from Baseline to Week 12 in Modified Clinical Global Impression of Change (mCGI-C) Raw Scores
Description
The mCGI-C will be used to assess the clinician's general impression of the participant's treatment response. The mCGI-C is a 7-point (1 to 7) modified version of the CGI-C scale. A higher score represents worsening of symptoms.
Time Frame
Baseline; Week 12
Title
Change from Baseline to Week 12 in NPI-C Rating Scale Subscales Scores for Aggression, Agitation, Irritability/Lability, and Disinhibition
Description
The NPI-C is used to rate the presence of neuropsychiatric symptoms across 14 domains. The scores for each item within an individual domain/subscale range from 0 to 3, with a higher score indicating increased severity.
Time Frame
Baseline; Week 12
Title
Change from Baseline to Week 12 in Modified Clinical Global Impression of Severity (mCGI-S) Scale Scores
Description
The mCGI-S will be used to assess the clinician's view of the participant's severity of aggression, agitation, and irritability symptoms. The mCGI-S is a 7-point (1 to 7) modified version of the CGI-S scale. In all cases, a higher score represents increased severity.
Time Frame
Baseline; Week 12
Title
Change from Baseline to Week 12 in Patient Global Impression of Severity (PGI-S) Scores
Description
The PGI-S is a single-question scale that specifically assesses the severity of symptoms of neurobehavioral disinhibition, including aggression, agitation, and irritability, on a 7-point scale : 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.
Time Frame
Baseline; Week 12
Title
Change from Baseline to Week 12 in Patient Global Impression of Change (PGI-C) Raw Scores
Description
The PGI-C is a 7-point (1 to 7) scale used to assess the participant's assessment of treatment response. A higher score indicates worsening of the symptoms.
Time Frame
Baseline; Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants with TBI Participants with neurobehavioral disinhibition symptoms that are present after trauma or after recovery of consciousness Score of ≥4 on the mCGI-S scale and the Agitation/Aggression or Irritability/Lability subscales of the Neuropsychiatric Inventory (NPI) scale at screening and baseline Participants with a reliable caregiver Exclusion Criteria: Participants with significant symptoms of a major depressive disorder Participants with a history of or current clinical symptoms of schizophrenia, schizoaffective disorder, bipolar disorder, antisocial personality disorder, or borderline personality disorder
Facility Information:
Facility Name
Tuscaloosa Veterans Affairs Medical Center
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35404
Country
United States
Facility Name
Absolute Clinical Research Site#207
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85051
Country
United States
Facility Name
Perseverance Research Center Site#152
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85254
Country
United States
Facility Name
ATP Clinical Research Site#150
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Kaizen Brain Center #224
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Sunwise Clinical Research, LLC Site#216
City
Lafayette
State/Province
California
ZIP/Postal Code
94543
Country
United States
Facility Name
Torrance Clinical Research Institute Site#157
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
Facility Name
Tibor Rubin VA Medical Center, SCIRE Biomedical Research Institute
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
Asclepes Research Centers - Panorama City Site #208
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Facility Name
The Neurology Group
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Facility Name
Mountain Mind
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80903
Country
United States
Facility Name
Mountain View Clinical Research, Inc. Site# 202
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Medical Center of the Rockies
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80538
Country
United States
Facility Name
Connecticut Clinical Research
City
Cromwell
State/Province
Connecticut
ZIP/Postal Code
06416
Country
United States
Facility Name
Bradenton Research Center, Inc
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
Healthcare Innovative Institute, LLC Site# 173
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33067
Country
United States
Facility Name
Science Connections, LLC Site#161
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Design Neuroscience Center, PL
City
Doral
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Facility Name
Alphab Global Research Site#163
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Meridien Research
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Premier Clinical Research Institute, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Facility Name
Project 4 Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Allied Biomedical Research Institute, Inc. Site#151
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Health Synergy Clinical Research
City
Okeechobee
State/Province
Florida
ZIP/Postal Code
34972
Country
United States
Facility Name
Roskamp Institute Clinic, Inc.
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34243
Country
United States
Facility Name
USF Dept of Psychiatry and Behavioral Neurosciences Site# 214
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Meridien Research Site# 108
City
Tampa
State/Province
Florida
ZIP/Postal Code
33634
Country
United States
Facility Name
Hawaii Pacific Neuroscience Site#184
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
The University of Kentucky research foundation
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Baptist Health
City
Richmond
State/Province
Kentucky
ZIP/Postal Code
40475
Country
United States
Facility Name
Sisu BHR Site#200
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01103
Country
United States
Facility Name
Neurobehavioral Medicine Group #222
City
Bloomfield Hills
State/Province
Michigan
ZIP/Postal Code
48302
Country
United States
Facility Name
Millennium Psychiatric Associates, LLC
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Sharlin Health and Neurology
City
Ozark
State/Province
Missouri
ZIP/Postal Code
65721
Country
United States
Facility Name
Clinical Research Professionals
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
JFK Johnson Rehabilitation Institute
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08820
Country
United States
Facility Name
The NeuroCognitive Insititute
City
Mount Arlington
State/Province
New Jersey
ZIP/Postal Code
07856
Country
United States
Facility Name
New York University School of Medicine Site #122
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Atrium Health - Carolinas Rehabilitation - Charlotte Site #166
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
New Hope Clinical Research Site#194
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Carolina Headache Institute
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States
Facility Name
Salisbury VAMC
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Valley Medical Research
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
Cincinnati VA Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
North Star Medical Research, LLC Site#154
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
IPS Research Site#196
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73106
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
WJB Dorn VA-Wm. Jennings Bryan Dorn VA Medical Center
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29205
Country
United States
Facility Name
University of Texas Southwestern Medical Site#140
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Polytrauma Rehabilitation Center S. Texas VA Health Care System Site# 146
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Cedar Clinical Research #221
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Facility Name
Virginia Commonwealth University #172
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Virginia Commonwealth University Site#172
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Salem Research Institute Site# 138
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States

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

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Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Neurobehavioral Disinhibition Including Aggression, Agitation, and Irritability in Participants With Traumatic Brain Injury

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