Safety, Tolerability and Effectiveness of Nuedexta in the Treatment of Pseudobulbar Affect (PBA)
PRISM II
A Study to Assess the Safety, Tolerability and Effectiveness of Nuedexta (Dextromethorphan 20 mg/Quinidine 10 mg) in the Treatment of Pseudobulbar Affect (PBA)
1 other identifier
interventional
367
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2013
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 25, 2013
CompletedFirst Posted
Study publicly available on registry
February 27, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedResults Posted
Study results publicly available
March 15, 2017
CompletedMarch 15, 2017
January 1, 2017
2.2 years
February 25, 2013
May 5, 2016
January 26, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Mean Change From Baseline in Center for Neurologic Study-Lability Scale (CNS-LS) Score at Day 90
The CNS-LS was a seven-item, self-administered questionnaire, completed by the participant or participant's caregiver that provided a quantitative measure of the perceived frequency and severity of Pseudobulbar Affect (PBA) episodes. It consisted of two subscales measuring labile laughter (four items) and labile crying (three items). Each item was rated on a scale from 1 (applies never) to 5 (applies most of the time). The total score was calculated as the sum of the item values that resulted in a score ranging from 7 (no symptoms) to 35 (maximum symptom severity and frequency). A single continuous variable was created for the reported time point. The change in CNS-LS was calculated as the score from the Day 90 assessment minus the Baseline CNS-LS measure. A negative change represented a decrease in CNS-LS score over time following the baseline assessment indicating a perceived decrease in frequency and severity of PBA episodes.
Day 90 (Final visit)
Secondary Outcomes (11)
Mean Change From Baseline in Center for Neurologic Study-Lability Scale (CNS-LS) Score at Day 30
Day 30
Mean Pseudobulbar Affect (PBA) Episode Count Per Week by Visit
Baseline (Day 1), Day 30 (Visit 1), and Day 90 (Final visit)
Percentage of Participants With PBA Remission
Day 30 (Visit 1) and Day 90 (Final visit)
Percentage Change From Baseline in PBA Episode Count Per Week
Day 30 (Visit 1) and Day 90 (Final visit)
Percentage of Participants With ≥ 50% Reduction in PBA Episode Count Per Week
Day 30 (Visit 1) and Day 90 (Final visit)
- +6 more secondary outcomes
Study Arms (1)
Nuedexta (DM 20 mg/Q 10 mg)
OTHERSingle Arm, Open Label Dosing with Nuedexta (DM 20 mg/Q 10 mg)
Interventions
Single Arm, Open-Label Dosing with Nuedexta (DM 20 mg/Q 10 mg)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Unstable neurologic disease
- Severe dementia
- Stroke within 3 months
- Penetrating TBI
- Contraindications to Nuedexta
- Severe Depressive Disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Pensacola, Florida, 32503, United States
Related Publications (3)
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.
PMID: 29477412DERIVEDHammond 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.
PMID: 27276999DERIVEDDoody 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.
PMID: 26471212DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Nadine Knowles; Executive Director, Research & Development Operations
- Organization
- Avanir Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2013
First Posted
February 27, 2013
Study Start
February 1, 2013
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
March 15, 2017
Results First Posted
March 15, 2017
Record last verified: 2017-01