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NCT03095066 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 2
- Development phase
- 168
- Enrollment target
NCT03095066: Completed Phase 2 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT03095066 is a Phase 2 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 168 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03095066, a Phase 2 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 168 participants
- Enrollment target
Study 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).
Primary Outcome
NPI-C is a retrospective informant/caregiver interview covering 12 neuropsychiatric symptom domains. These are collectively rated first by the informant/caregiver based on frequency (0-4);severity (0-3);informant/caregiver distress (0-5) \& then by the participant based on frequency (0-4), which the clinician then integrates into a (0-3) clinical impression severity rating. NPI-C-3= aggression, agitation, \& irritability/lability subscales. NPI-C agitation domain= sum of clinical impression seve
Interventions
- DRUG Placebo
- DRUG AVP-786-28
- DRUG AVP-786-42.63
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 168 participants |
| Start Date | 2017-05-30 |
| Est. Completion | 2022-08-31 |
| Phase | Phase 2 |
What the finished NCT03095066 record still lists
NCT03095066 is an interventional study that assigns participants to a tested intervention. The registered 168 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03095066 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03095066 about?
NCT03095066 is a clinical study titled "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". 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).
What is the current status of trial NCT03095066?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 168 participants. The study started on 2017-05-30. Estimated completion is 2022-08-31.
What interventions are being tested in trial NCT03095066?
The interventions under investigation include: Placebo (DRUG), AVP-786-28 (DRUG), AVP-786-42.63 (DRUG).
Who is sponsoring clinical trial NCT03095066?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03095066's enrollment target sits among peer trials
168 403rd of 2000 higher than 1,595 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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