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

  • STATUS
    Recruiting
Updated on 23 November 2020

Summary

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

Description

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.

Location: Baylor University Medical Center

IRB Number: 013-161

Facility Name: Multiple Sclerosis Treatment Center of Dallas

Facility Street Address: 3600 Gaston Ave., Wadley Tower Suite 1155
City: Dallas, TX Zip Code: 75246

Lead Principal Investigator: Dr. Chaouki Khoury

Details
Clinical Study IdentifierTX138958
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 0 yrs?
Gender: Male or Female
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

Stroke within the last 3 months
Penetrating (open) head injury
Currently hospitalized in a mental health facility
Diagnosis of myasthenia gravis
Diagnosis of Severe Dementia, Severe Depressive Disorder, schizophrenia, or bipolar disorder
History of complete heart block
Received NUEDEXTA within the last 6 months
History of drug or alcohol abuse within the last 3 years
Females who are pregnant or planning to become pregnant during the study
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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