Safety Study of AVP-923 in the Treatment of IEED (Involuntary Emotional Expression Disorder) Also Known as Pseudobulbar Affect (Episodes of Uncontrolled Crying and/or Laughter)

Completed

Phase 3 Results N/A

Trial Description

The purpose of this study is to evaluate the long-term safety of AVP-923 in the treatment of Involuntary Emotional Expression Disorder (IEED) also known as Pseudobulbar Affect (episodes of uncontrolled crying and/or laughter).

Detailed Description

This is an "open label" study which means there is no placebo group. Each subject enrolled into the study will receive AVP-923.

Conditions

Interventions

  • Neurodex (AVP 923)Drug
    Intervention Desc: A dual-action glutamate inhibitor that helps to regulate hyperexcitatory neurotransmission, which is implicated in Involuntary Emotional Expression Disorder (IEED) by regulating excitatory neurotransmission in two ways, through presynaptic inhibition of glutamate release via sigma-1 receptor agonist activity, and through postsynaptic glutamate response modulation via uncompetitive, low-affinity NMDA antagonist activity.
  • AVP-923 Drug

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Emotional control.
Primary emotional control

Sponsors