Pseudobulbar Affect (PBA) | Safety, Tolerability and Effectiveness of Nuedexta in the Treatment of Pseudobulbar Affect (PBA)
Pseudobulbar Affect (PBA) research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - Center for Neurologic Study-Lability Scale (CNS-LS)score of 13 or greater - Clinical diagnosis of Pseudobulbar Affect (PBA) - Documentation of Neurologic disease or brain injury Exclusion Criteria: - Unstable neurologic disease - Severe dementia - Stroke within 3 months - Penetrating TBI - Contraindications to Nuedexta - Severe Depressive Disorder
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Pseudobulbar Affect (PBA)
Traumatic Brain Injury (TBI)
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Nuedexta (DM 20 mg/Q 10 mg)Single Arm, Open-Label Dosing with Nuedexta (DM 20 mg/Q 10 mg)
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Nuedexta (DM 20 mg/Q 10 mg)Single Arm, Open Label Dosing with Nuedexta (DM 20 mg/Q 10 mg)
Start Date: February 2013
Completed Date: May 2015
Phase: Phase 4
Primary Outcome: Mean Change From Baseline in Center for Neurologic Study-Lability Scale (CNS-LS) Score at Day 90
Secondary Outcome: Mean Change From Baseline in Center for Neurologic Study-Lability Scale (CNS-LS) Score at Day 30
Study sponsors, principal investigator, and references
Lead Sponsor: Avanir Pharmaceuticals