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Safety, Tolerability and Effectiveness of Nuedexta in the Treatment of Pseudobulbar Affect (PBA) (PRISM II)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01799941
First Posted: February 27, 2013
Last Update Posted: March 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Avanir Pharmaceuticals
February 25, 2013
February 27, 2013
May 5, 2016
March 15, 2017
March 15, 2017
February 2013
May 2015   (Final data collection date for primary outcome measure)
Mean Change From Baseline in Center for Neurologic Study-Lability Scale (CNS-LS) Score at Day 90 [ Time Frame: Day 90 (Final visit) ]
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.
The primary efficacy endpoint is the mean change from baseline at 12 weeks in CNS-LS score. [ Time Frame: 12 weeks ]
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.
Complete list of historical versions of study NCT01799941 on ClinicalTrials.gov Archive Site
  • Mean Change From Baseline in Center for Neurologic Study-Lability Scale (CNS-LS) Score at Day 30 [ Time Frame: Day 30 ]
    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 30 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.
  • Mean Pseudobulbar Affect (PBA) Episode Count Per Week by Visit [ Time Frame: Baseline (Day 1), Day 30 (Visit 1), and Day 90 (Final visit) ]
    PBA episode count was an investigator assessed measure in which the participant/participant's daytime caregiver was asked to identify, count and recall the total episodes of exaggerated/uncontrollable laughing or crying over the previous 7 days (prior to visit) at Baseline (Day 1), Day 30 (Visit 1), and Day 90 (Final visit). The response categories for this question were: 0, 1- 2, 3-5, 6-10, >10. The original responses from participants were converted to estimate the continuous number of PBA episodes by taking the mid-point of the original response ranges and multiplying that value by 7. Data is presented as mean PBA count per week.
  • Percentage of Participants With PBA Remission [ Time Frame: Day 30 (Visit 1) and Day 90 (Final visit) ]
    PBA remission was defined as participants with one or more episodes reported at the baseline (Day 1) visit and zero episodes reported at the Day 30 (Visit 1) or Day 90 (Final visit). Data is reported as percentage of participants with no reported episodes over the previous 7 days (prior to visit) at Day 30 (Visit 1) and Day 90 (Final visit).
  • Percentage Change From Baseline in PBA Episode Count Per Week [ Time Frame: Day 30 (Visit 1) and Day 90 (Final visit) ]
    The change from the baseline PBA rate was measured using Mixed Effects Poisson Regression Model (adjusted for gender and age [≤ 65 years]).
  • Percentage of Participants With ≥ 50% Reduction in PBA Episode Count Per Week [ Time Frame: Day 30 (Visit 1) and Day 90 (Final visit) ]
    Data is reported as the percentage of participants with ≥ 50% reduction in PBA episode count/week.
  • Percentage of Participants With ≥ 75% Reduction in PBA Episode Count Per Week [ Time Frame: Day 30 (Visit 1) and Day 90 (Final visit) ]
    Data is reported as the percentage of participants with ≥ 75% reduction in PBA episode count/week.
  • Mean Change From Baseline in Quality of Life Visual Analog Scale (QOL-VAS) Score at Day 90 [ Time Frame: Day 90 (Final visit) ]
    The QOL-VAS, a participant reported scale of quality of life (QOL) was used to measure the impact of PBA episodes on the participant's QOL over the previous 7 days (prior to visit) at Baseline (Day 1) and Day 90 (Final visit). The assessment was completed by a participant placing a mark on a horizontal line that extends from 0 "not (affected) at all" to 10 "significantly (affected)". The participant's mark was measured and recorded at each time point. The change in QOL-VAS score from baseline to day 90 visit, defined as the day 90 score minus the baseline score, was analyzed. Data is reported as mean QOL-VAS score; a positive change in score represented an increase in participant's quality of life.
  • Percentage of Participants With Clinical Global Impression-Change (CGI-C) Score at Day 90 [ Time Frame: Day 90 (Final visit) ]
    CGI-C, an investigator-assessed scale was used to measure the overall treatment response. CGI-C, a 7-point (1-7) scale was rated as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. Data is presented as percentage of participants with CGI-C score at Day 90. Percentages within a measure may not sum to 100.0 due to rounding. Percentages use the count of participants with non-missing data as the denominator.
  • Percentage of Participants With Patient Global Impression-Change (PGI-C) Score at Day 90 [ Time Frame: Day 90 (Final visit) ]
    PGI-C, a participant/participant's caregiver-assessed scale was used to measure participant overall treatment response. PGI-C, a 7-point (1-7) scale was rated as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. Data is presented as percentage of participants with PGI-C score at Day 90. Percentages within a measure may not sum to 100.0 due to rounding. Percentages use the count of participants with non-missing data as the denominator.
  • Percentage of Participants With Treatment Satisfaction Survey [ Time Frame: Day 90 (Final visit) ]
    The treatment satisfaction survey was a 5 point single question survey that was administered by the site staff to the participant/participant's caregiver. Participants were asked to rate their response to treatment satisfaction as: very dissatisfied, somewhat dissatisfied, neither satisfied nor dissatisfied, somewhat satisfied, and very satisfied. Data is presented as percentage of participants with treatment satisfaction at Day 90. Percentages within a measure may not sum to 100.0 due to rounding. Percentages use the count of participants with non-missing data as the denominator.
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From signing of informed consent up to 30 days after receiving the last dose of study drug or up to approximately 120 days ]
    AEs (defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) and SAEs (defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening [ie, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death], required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was as a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug) were assessed during the study.
  • Safety and Tolerability [ Time Frame: 12 weeks ]
    Assessments to include Patient History, Medication History,Concomitant Medication and Adverse Events.
  • PBA Episode Counts [ Time Frame: 12 weeks ]
    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.
  • Other Patient Reported Outcomes [ Time Frame: 12 Weeks ]
    Includes Patient Global Impression-Change (PGI-C), which is a 7-point (1-7) scale, where a patient/patient's caregiver assesses the patient's overall treatment response, and the Patient Satisfaction with Treatment Survey, which is a 5 point single question survey that will be administered by the site staff to the patient/patient's caregiver.
Not Provided
Not Provided
 
Safety, Tolerability and Effectiveness of Nuedexta in the Treatment of Pseudobulbar Affect (PBA)
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 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.

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.

Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Pseudobulbar Affect (PBA)
  • Stroke
  • Dementia
  • Traumatic Brain Injury (TBI)
Drug: Nuedexta (DM 20 mg/Q 10 mg)
Single Arm, Open-Label Dosing with Nuedexta (DM 20 mg/Q 10 mg)
Other Name: Nuedexta
Nuedexta (DM 20 mg/Q 10 mg)
Single Arm, Open Label Dosing with Nuedexta (DM 20 mg/Q 10 mg)
Intervention: Drug: Nuedexta (DM 20 mg/Q 10 mg)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
367
May 2015
May 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01799941
12-AVR-401
No
Not Provided
Not Provided
Avanir Pharmaceuticals
Avanir Pharmaceuticals
Not Provided
Not Provided
Avanir Pharmaceuticals
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP