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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 is a Phase 2 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 168 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03095066
The ClinicalTrials.gov registry entry for NCT03095066 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 168 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03095066 reports 0 study locations.
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.
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