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 PBA in patients with prevalent conditions such as dementia, stroke and traumatic brain injury over a 12 week period.
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 CNS Lability scale (CNS-LS). Secondary objectives include measures to evaluate treatment outcomes.
- Nuedexta (DM 20 mg/Q 10 mg) Drug
Other Names: Nuedexta Intervention Desc: Single Arm, Open-Label Dosing with Nuedexta (DM 20 mg/Q 10 mg) ARM 1: Kind: Experimental Label: Nuedexta (DM 20 mg/Q 10 mg) Description: Open Label - Nuedexta (DM 20 mg/Q 10 mg)
- Allocation: Non-Randomized
- Masking: Open Label
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Single Group Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||The primary efficacy endpoint is the mean change from baseline at 12 weeks in CNS-LS score.||12 weeks||No|
|Secondary||Safety and Tolerability||12 weeks||Yes|
|Secondary||PBA Episode Counts||12 weeks||No|
|Secondary||Other Patient Reported Outcomes||12 Weeks||No|
|Secondary||Patient Global Impression-Change (PGI-C)||12 Weeks||No|
|Secondary||Clinical Global Impression-Change (CGI-C)||12 Weeks||No|
|Secondary||Patient Satisfaction with Treatment Survey||12 Weeks||No|