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Clinical trial

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).

NCT03095066 is registered in ClinicalTrials.gov with Otsuka Pharmaceutical Development & Commercialization, Inc. as lead sponsor.

NCT NCT03095066
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Registry record

As filed in ClinicalTrials.gov.

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).
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Phase
Phase 2
Overall status
Completed
Start date
May 30, 2017
Completion date
August 31, 2022
Enrollment
168 (actual)
Sites
54

Conditions

As the registry lists them; a condition with its own page is linked.

neurobehavioral disinhibition