Safety, Tolerability and Effectiveness of Nuedexta in the Treatment of Pseudobulbar Affect (PBA) (PRISM II)
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.
Pseudobulbar Affect (PBA)
Traumatic Brain Injury (TBI)
Drug: Nuedexta (DM 20 mg/Q 10 mg)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Study to Assess the Safety, Tolerability and Effectiveness of Nuedexta (Dextromethorphan 20 mg/Quinidine 10 mg) in the Treatment of Pseudobulbar Affect (PBA)|
- The primary efficacy endpoint is the mean change from baseline at 12 weeks in CNS-LS score. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]The CNS-LS is a short (seven-item), self-administered questionnaire, designed to be completed by the patient or patient's caregiver, that provides a quantitative measure of the perceived frequency and severity of PBA episodes.
- Safety and Tolerability [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]Assessments to include Patient History, Medication History,Concomitant Medication and Adverse Events.
- PBA Episode Counts [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]The PBA episode count is for the investigator to ask patient or patient's daytime caregiver to recall the PBA episodes. The Patient or patient's caregiver will be instructed to identify, count and recall the average daily episodes of exaggerated/uncontrollable laughing or crying.
- Patient Global Impression-Change (PGI-C) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]A 7-point (1-7) scale, where a patient/patient's caregiver assesses the patient's overall treatment response.
- Clinical Global Impression-Change (CGI-C) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]The CGI-C is a 7-point (1-7) scale and is an investigator-rated scale to assess the overall treatment response.
- Patient Satisfaction with Treatment Survey [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]The Patient treatment satisfaction survey is a 5 point single question survey that will be administered by the site staff to the patient/patient's caregiver.
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Nuedexta (DM 20 mg/Q 10 mg)
Single Arm, Open Label Dosing with Nuedexta (DM 20 mg/Q 10 mg)
Drug: Nuedexta (DM 20 mg/Q 10 mg)
Single Arm, Open-Label Dosing with Nuedexta (DM 20 mg/Q 10 mg)
Other Name: Nuedexta
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01799941
|United States, Florida|
|Pensacola, Florida, United States, 32503|