Conditions: Pseudobulbar Affect (PBA) Stroke Dementia Traumatic Brain Injury (TBI)
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 367
Healthy volunteers: no

Brief summary:
The objectives of the study are to evaluate the safety, tolerability, and effectiveness of NUEDEXTA capsules containing 20 mg DM (Dextromethorphan)/10 mg Q (Quinidine) for treatment of Pseudobulbar Affect (PBA) in patients with prevalent conditions such as dementia, stroke, and traumatic brain injury (TBI)over a 12 week period.

Detailed description:
This will be an Open-label, Multicenter, study in patients with PBA and dementia, stroke or TBI. Patients with a clinical diagnosis of PBA and who meet all other inclusion and exclusion criteria will be eligible to participate and receive NUEDEXTA for 12 weeks.

Males and females patients with a minimum age of 18 years, a clinical diagnosis of Pseudobulbar Affect and a documented diagnosis of neurologic disease or brain injury, will be enrolled in this study.

The primary effectiveness endpoint is the mean change in the Center for Neurologic Study-Lability scale (CNS-LS). Secondary objectives include measures to evaluate treatment outcomes.

Arms:
arm 1: Single Arm, Open Label Dosing with Nuedexta (DM 20 mg/Q 10 mg)

Interventions: intervention 1: Nuedexta (DM 20 mg/Q 10 mg)
Intervention descriptions: intervention 1: Single Arm, Open-Label Dosing with Nuedexta (DM 20 mg/Q 10 mg)

Protocol document: