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.
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.
Nearly 2 million Americans with certain neurologic conditions or brain injuries are estimated to suffer from PBA. PBA can affect men and women, old and young.
PRISM II is a 12-week long study testing the safety and effectiveness of NUEDEXTA in the treatment of PBA in post-stroke, dementia and traumatic brain injury (TBI) patients.
NUEDEXTA is an FDA-approved treatment for PBA. NUEDEXTA is a combination of two drugs, dextromethorphan and quinidine.
During the three-month duration of the study, participants will be asked to visit the investigator site three times for safety and effectiveness measures and study-related examinations.
- There are no costs to participate.
- Participants will receive study-related medical care at no cost.
- Participants will receive study medication at no cost.
How to Participate in PRISM II
Participation in the study is only possible if you visit one of the qualified investigation sites. Your eligibility to participate in the study will be assessed upon your contacting or visiting the investigation site. This decision can only be made by the physicians who have been trained for the study.
To learn more about this study or to find out if a qualified study site is reachable for you (or your patients), please go to http://www.avanirclinicaltrials.com/prism-II or call 1 (855) 477-4762.
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.