Study of NUEDEXTA in the Treatment of Pseudobulbar Affect (PBA)

Updated on 8 November 2020


Study of NUEDEXTA in the Treatment of Pseudobulbar Affect (PBA)


This is a 12-week study that will assess the safety and effectiveness of NUEDEXTA (Dextromethorphan 20mg/Quinidine10mg) in people who have Pseudobulbar Affect (PBA). PBA is a medical condition that causes sudden and involuntary bouts of crying or laughing in people with certain neurologic conditions or brain injuries. NUEDEXTA is currently FDA approved.

Clinical Study IdentifierTX138748
Last Modified on8 November 2020


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Inclusion Criteria

Age 18 or older
Diagnosis of Pseudobulbar Affect (PBA) which causes sudden and involuntary outbursts of crying or laughing
Diagnosis of neurologic disease or brain injury such as dementia, stroke, or traumatic brain injury (TBI)
If taking a dementia medication must be on stable dose for at least 6 weeks
It taking an antidepressant, antipsychotic, etc. must be on stable dose for at least 2 months
Other inclusion criteria may apply

Exclusion Criteria

Other exclusion criteria may apply
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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