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

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.
 
ClinicalTrials.gov Identifier: NCT01799941
Recruitment Status : Completed
First Posted : February 27, 2013
Results First Posted : March 15, 2017
Last Update Posted : March 15, 2017
Sponsor:
Information provided by (Responsible Party):
Avanir Pharmaceuticals

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pseudobulbar Affect (PBA) Stroke Dementia Traumatic Brain Injury (TBI) Drug: Nuedexta (DM 20 mg/Q 10 mg) Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 367 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : February 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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]).

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799941


Locations
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United States, Florida
Pensacola, Florida, United States, 32503
Sponsors and Collaborators
Avanir Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Avanir Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01799941    
Other Study ID Numbers: 12-AVR-401
First Posted: February 27, 2013    Key Record Dates
Results First Posted: March 15, 2017
Last Update Posted: March 15, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Quinidine
Dextromethorphan
Antitussive Agents
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Anti-Arrhythmia Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Voltage-Gated Sodium Channel Blockers