Please type in your zip code to find the clinical trial site nearest you.

Postal code   

PRISM II

Pseudobulbar affect Registry Investigating Symptom Management
  • PRISM II is a real world registry to study the safety and effectiveness of NUEDEXTA in the treatment of pseudobulbar affect (PBA) in post stroke, dementia and traumatic brain injury (TBI) patients.

Tell me more about the PRISM II study

  • PRISM II is a 12 week long study testing the safety and effectiveness of NUEDEXTA in the treatment of pseudobulbar affect (PBA) in post stroke, dementia and traumatic brain injury (TBI) patients.
  • NUEDEXTA is an FDA approved treatment for pseudobulbar affect (PBA).
  • During the duration of the study, participants will be asked to visit the investigator site 3 times for:
    • Study related examinations
    • Safety and effectiveness measures

What is pseudobulbar affect (PBA)?

Pseudobulbar affect is a neurologic condition that can occur when certain neurologic diseases or brain injuries damage the areas of the brain that control normal expression of emotion. The condition of pseudobulbar affect (PBA) results in episodes of crying or laughing that are often sudden and exaggerated or do not match what the person is feeling inside.

What is NUEDEXTA?

NUEDEXTA is a combination of two drugs, dextromethorphan and quinidine.

Who can participate in the study?

Stroke, dementia and traumatic brain injury patients with uncontrollable or exaggerated episodes of crying or laughter can be screened for eligibility for the study.

Are there any costs to participate?

  • There are no costs to participate.
  • Participants will receive study-related medical care at no cost.
  • Participants will receive study medication at no cost.
 
NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate) 20mg/10mg capsules can interact with other medications and cause serious side effects. NUEDEXTA is contraindicated in patients taking certain drugs and in patients with specific cardiovascular risk factors. These are not all the risks from use of NUEDEXTA. Please see the Important Safety Information and full Prescribing Information