Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Neurobehavioral Disinhibition Including Aggression, Agitation, and Irritability in Patients With Traumatic Brain Injury
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ClinicalTrials.gov Identifier: NCT03095066 |
Recruitment Status :
Recruiting
First Posted : March 29, 2017
Last Update Posted : April 8, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Neurobehavioral Disinhibition | Drug: AVP-786 Drug: Placebo | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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). |
Actual Study Start Date : | May 30, 2017 |
Estimated Primary Completion Date : | October 2022 |
Estimated Study Completion Date : | October 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: AVP-786
Dose 1 capsules administered twice a day over a 12-week period
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Drug: AVP-786
oral capsules Drug: Placebo oral capsules |
Placebo Comparator: Placebo
Placebo capsules administered twice a day over a 12-week period
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Drug: Placebo
oral capsules |
- 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) [ Time Frame: Baseline; Week 12 ]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.
- Change from Baseline to Week 12 in Modified Clinical Global Impression of Change (mCGI-C) Raw Scores [ Time Frame: Baseline; Week 12 ]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 [ Time Frame: Baseline; Week 12 ]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 [ Time Frame: Baseline; Week 12 ]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 [ Time Frame: Baseline; Week 12 ]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 [ Time Frame: Baseline; Week 12 ]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.

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03095066
Contact: Jurandir Araujo | (949) 339-0175 | jaraujo@avanir.com | |
Contact: Nadine Knowles | nknowles@avanir.com |

Responsible Party: | Avanir Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT03095066 |
Other Study ID Numbers: |
17-AVP-786-205 |
First Posted: | March 29, 2017 Key Record Dates |
Last Update Posted: | April 8, 2021 |
Last Verified: | April 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
aggression agitation irritability non-penetrating brain injury |
traumatic brain injury TBI AVP-786 |
Brain Injuries Brain Injuries, Traumatic Psychomotor Agitation Aggression Wounds and Injuries Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Craniocerebral Trauma Trauma, Nervous System Dyskinesias Neurologic Manifestations Psychomotor Disorders Neurobehavioral Manifestations Behavioral Symptoms |