NCT02534038

Safety, Tolerability and Efficacy of AVP-786 for the Treatment of Disinhibition

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Efficacy of AVP-786 for the Treatment of Disinhibition in Patients With Neurodegenerative Disorders

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Avanir Pharmaceuticals · Industry
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Treatment of disinhibition syndrome in participants with Neurodegenerative Disorder.

Detailed description

Eligible participants for this study must have a diagnosis of Neurodegenerative Disorder and must exhibit disinhibition syndrome of sufficient severity to warrant treatment. This is a multicenter, randomized, double-blind, placebo-controlled, cross-over study consisting of two 6-week treatment periods. Approximately 12 participants will be enrolled at approximately 2 centers in the United States. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.

Conditions

• Disinhibition Syndrome

Interventions

Type	Name	Description
DRUG	AVP-786	d6-DM/Q
DRUG	Placebo	matching placebo

Timeline

• Start date: 2015-12-01
• Primary completion: 2017-10-03
• Completion: 2017-10-03
• First posted: 2015-08-27
• Last updated: 2020-10-26
• Results posted: 2020-10-26

Locations

1 site across 1 country: United States