Clinical trial NCT01799941: Safety, Tolerability and Effectiveness of Nuedexta in the Treatment of Pseudobulbar Affect (PBA)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pseudobulbar Affect (PBA)
Stroke
Dementia
Traumatic Brain Injury (TBI)
Lead sponsor: Avanir Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-02-27
Enrollment: 367
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Change From Baseline in Center for Neurologic Study-Lability Scale (CNS-LS) Score at Day 90
timeFrame: Day 90 (Final visit)
Secondary outcomes:
measure: Mean Change From Baseline in Center for Neurologic Study-Lability Scale (CNS-LS) Score at Day 30
timeFrame: Day 30
measure: Mean Pseudobulbar Affect (PBA) Episode Count Per Week by Visit
timeFrame: Baseline (Day 1), Day 30 (Visit 1), and Day 90 (Final visit)
measure: Percentage of Participants With PBA Remission
timeFrame: Day 30 (Visit 1) and Day 90 (Final visit)
measure: Percentage Change From Baseline in PBA Episode Count Per Week
timeFrame: Day 30 (Visit 1) and Day 90 (Final visit)
measure: Percentage of Participants With ≥ 50% Reduction in PBA Episode Count Per Week
timeFrame: Day 30 (Visit 1) and Day 90 (Final visit)
measure: Percentage of Participants With ≥ 75% Reduction in PBA Episode Count Per Week
timeFrame: Day 30 (Visit 1) and Day 90 (Final visit)
measure: Mean Change From Baseline in Quality of Life Visual Analog Scale (QOL-VAS) Score at Day 90
timeFrame: Day 90 (Final visit)
measure: Percentage of Participants With Clinical Global Impression-Change (CGI-C) Score at Day 90
timeFrame: Day 90 (Final visit)
measure: Percentage of Participants With Patient Global Impression-Change (PGI-C) Score at Day 90
timeFrame: Day 90 (Final visit)
measure: Percentage of Participants With Treatment Satisfaction Survey
timeFrame: Day 90 (Final visit)
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From signing of informed consent up to 30 days after receiving the last dose of study drug or up to approximately 120 days
Other outcomes:
Locations:
city: Pensacola
country: United States
state: Florida
Study officials:
References:
citation: Hammond FM, Sauve W, Ledon F, Davis C, Formella AE. Safety, Tolerability, and Effectiveness of Dextromethorphan/Quinidine for Pseudobulbar Affect Among Study Participants With Traumatic Brain Injury: Results From the PRISM-II Open Label Study. PM R. 2018 Oct;10(10):993-1003. doi: 10.1016/j.pmrj.2018.02.010. Epub 2018 Feb 23.
citation: Hammond FM, Alexander DN, Cutler AJ, D'Amico S, Doody RS, Sauve W, Zorowitz RD, Davis CS, Shin P, Ledon F, Yonan C, Formella AE, Siffert J. PRISM II: an open-label study to assess effectiveness of dextromethorphan/quinidine for pseudobulbar affect in patients with dementia, stroke or traumatic brain injury. BMC Neurol. 2016 Jun 9;16:89. doi: 10.1186/s12883-016-0609-0.
citation: Doody RS, D'Amico S, Cutler AJ, Davis CS, Shin P, Ledon F, Yonan C, Siffert J. An open-label study to assess safety, tolerability, and effectiveness of dextromethorphan/quinidine for pseudobulbar affect in dementia: PRISM II results. CNS Spectr. 2016 Dec;21(6):450-459. doi: 10.1017/S1092852915000620. Epub 2015 Oct 16.