Houston Methodist. Leading Medicine.
Houston Methodist. Leading Medicine

Nantz National Alzheimer Center

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Treatment of Pseudobulbar Affect (PBA)
For more information please contact Lenis Sosa at 281-507-8229, Jennifer Garrett at 281-222-9983 or Dr. Bryan Spann at 713-441-1150. Print Flyer

Clinical Trials

Neudexta in the Treatment of Pseudobulbar Affect (PBA)

Principal Investigator: Bryan M. Spann, D.O., Ph.D., Clinical Director NNAC

Certain Brain injuries or Neurological Disease (stroke, dementia or traumatic brain injury) can cause a condition called PBA. Patients with PBA describe uncontrolled outbursts of crying or laughing that aren’t connected to the way they are feeling inside. In other situations, the expression of emotions may be appropriate but it is exaggerated, is more intense or last longer than is called for. PBA is not depression. However, some patients may have both conditions. This is an open-labeled Phase 4 study to evaluate the safety, efficacy and tolerability of Neudexta in subjects with PBA and one of the following conditions such as dementia, stoke and traumatic brain injury (TBI) over a 12 week period.

  • Sponsor: Avanir Pharmaceuticals
  • 3 Month Trial
  • Three visits plus one telephone interview
  • Oral medication Neudexta to be used twice-a-day
  • Clinical Trials Identifier: NTC01799941

To Qualify Subjects Must Meet The Following Criteria

Inclusion Criteria

  • Center for Neurological Study-Lability Scale (CNS-LS) score of 13 or greater.
  • Clinical Diagnosis of PBA
  • Documentation of Neurological disease or brain injury

Exclusion Criteria

  • Unstable neurological disease
  • Severe Dementia
  • Stroke within 3 months
  • Penetrating TBI
  • Contradictions to Neudexta
  • Severe Depressive Disorder