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Trial record 3 of 8 for:    Pelizaeus-Merzbacher Disease

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

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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 Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Pseudobulbar Affect (PBA)
Stroke
Dementia
Traumatic Brain Injury (TBI)
Intervention Drug: Nuedexta (DM 20 mg/Q 10 mg)
Enrollment 367

Recruitment Details  
Pre-assignment Details A total of 394 participants were screened of which 367 participants were enrolled in the study; 134 in the dementia cohort, 113 in the stroke cohort, and 120 in the traumatic brain injury (TBI) cohort.
Arm/Group Title Dextromethorphan Hydrobromide 20 mg + Quinidine Sulfate 10 mg
Hide Arm/Group Description Participants who received fixed-dose combination of 20 milligram (mg) dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Period Title: Overall Study
Started 367
Completed 271
Not Completed 96
Reason Not Completed
Adverse Event             34
Withdrawal by Subject             21
Death             2
Investigator Decision             4
Lack of Efficacy             3
Lost to Follow-up             17
Not Specified             15
Arm/Group Title Dextromethorphan Hydrobromide 20 mg + Quinidine Sulfate 10 mg
Hide Arm/Group Description Participants who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Overall Number of Baseline Participants 367
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 367 participants
<=18 years
0
   0.0%
Between 18 and 65 years
215
  58.6%
>=65 years
152
  41.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 367 participants
Female
202
  55.0%
Male
165
  45.0%
1.Primary Outcome
Title Mean Change From Baseline in Center for Neurologic Study-Lability Scale (CNS-LS) Score at Day 90
Hide Description 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.
Time Frame Day 90 (Final visit)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed using the Modified Intent-to-treat (mITT) Population, defined as all participants who met all inclusion criteria, with a score of at least 13 on the CNS-LS, who received at least 1 dose of study drug, and who had at least 1 post-baseline efficacy measurement with CNS-LS.
Arm/Group Title Overall Dementia Stroke Traumatic Brain Injury
Hide Arm/Group Description:
Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Overall Number of Participants Analyzed 261 102 92 67
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-7.69  (6.07) -7.22  (6.04) -7.59  (6.67) -8.54  (5.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall
Comments The primary analysis tested the null hypothesis that the mean change in CNS-LS score from Baseline to Day 90 visit is equal to zero.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method One sample t-test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dementia
Comments The primary analysis tested the null hypothesis that the mean change in CNS-LS score from Baseline to Day 90 visit is equal to zero.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method one-sample t-test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Stroke
Comments The primary analysis tested the null hypothesis that the mean change in CNS-LS score from Baseline to Day 90 visit is equal to zero.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method One-sample t-test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Traumatic Brain Injury
Comments The primary analysis tested the null hypothesis that the mean change in CNS-LS score from Baseline to Day 90 visit is equal to zero.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method One-sample t-test
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Dementia, Stroke
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Analysis of covariance (ANCOVA)
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
-1.37 to 1.45
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.72
Estimation Comments A positive estimate indicates a smaller change in the first group. Observations used =261.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Stroke, Traumatic Brain Injury
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ANCOVA
Estimated Value 1.11
Confidence Interval (2-Sided) 95%
-0.46 to 2.68
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.80
Estimation Comments A positive estimate indicates a smaller change in the first group. Observations used =261.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Dementia, Traumatic Brain Injury
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ANCOVA
Estimated Value 1.15
Confidence Interval (2-Sided) 95%
-0.39 to 2.69
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.78
Estimation Comments A positive estimate indicates a smaller change in the first group. Observations used =261.
2.Secondary Outcome
Title Mean Change From Baseline in Center for Neurologic Study-Lability Scale (CNS-LS) Score at Day 30
Hide Description 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.
Time Frame Day 30
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed using the mITT population, defined as all participants who met all inclusion criteria, with a score of at least 13 on the CNS-LS, who received at least 1 dose of study drug, and who had at least 1 post-baseline efficacy measurement with CNS-LS.
Arm/Group Title Overall Dementia Stroke Traumatic Brain Injury
Hide Arm/Group Description:
Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Overall Number of Participants Analyzed 297 108 103 86
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-5.43  (5.52) -4.60  (5.08) -6.17  (6.12) -5.58  (5.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method One-sample t-test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dementia
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method One-sample t-test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Stroke
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method One-sample t-test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Traumatic Brain Injury
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method One-sample t-test
Comments [Not Specified]
3.Secondary Outcome
Title Mean Pseudobulbar Affect (PBA) Episode Count Per Week by Visit
Hide Description 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.
Time Frame Baseline (Day 1), Day 30 (Visit 1), and Day 90 (Final visit)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all participants who met all inclusion criteria, including a score of at least 13 on the CNS-LS, who received at least 1 dose of study drug, and who had at least 1 post-baseline efficacy measurement with PBA episode.
Arm/Group Title Overall Dementia Stroke Traumatic Brain Injury
Hide Arm/Group Description:
Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Overall Number of Participants Analyzed 298 108 103 87
Mean (Standard Deviation)
Unit of Measure: Count/week
Baseline 21.33  (24.97) 25.68  (23.06) 19.62  (29.62) 17.94  (20.31)
Day 30 (n= 296, 108, 102, 86) 9.10  (14.29) 12.85  (16.80) 6.95  (11.83) 6.94  (12.60)
Day 90 (n= 260, 102, 92, 66) 6.23  (11.45) 8.41  (14.26) 5.26  (9.60) 4.20  (8.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall
Comments Day 30 versus Baseline
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method One-sample t-test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Overall
Comments Day 90 versus Baseline
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method One-sample t-test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Dementia
Comments Day 30 versus Baseline
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method One-sample t-test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Dementia
Comments Day 90 assessment
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method One-sample t-test
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Stroke
Comments Day 30 versus Baseline
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method One-sample t-test
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Stroke
Comments Day 90 versus Baseline
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method One-sample t-test
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Traumatic Brain Injury
Comments Day 30 versus Baseline
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method One-sample t-test
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Traumatic Brain Injury
Comments Day 90 versus Baseline
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method One-sample t-test
Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With PBA Remission
Hide Description 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).
Time Frame Day 30 (Visit 1) and Day 90 (Final visit)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all participants who met all inclusion criteria, including a score of at least 13 on the CNS-LS, who received at least 1 dose of study drug, and who had at least 1 post-baseline efficacy measurement with PBA episode.
Arm/Group Title Overall Dementia Stroke Traumatic Brain Injury
Hide Arm/Group Description:
Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Overall Number of Participants Analyzed 298 108 103 87
Measure Type: Number
Unit of Measure: Percentage of participants
Day 30 (n= 296, 108, 102, 86) 20.3 13.0 22.5 26.7
Day 90 (n= 260, 102, 92, 66) 35.4 31.4 34.8 42.4
5.Secondary Outcome
Title Percentage Change From Baseline in PBA Episode Count Per Week
Hide Description The change from the baseline PBA rate was measured using Mixed Effects Poisson Regression Model (adjusted for gender and age [≤ 65 years]).
Time Frame Day 30 (Visit 1) and Day 90 (Final visit)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all participants who met all inclusion criteria, including a score of at least 13 on the CNS-LS, who received at least 1 dose of study drug, and who had at least 1 post-baseline efficacy measurement with PBA episode.
Arm/Group Title Overall Dementia Stroke Traumatic Brain Injury
Hide Arm/Group Description:
Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Overall Number of Participants Analyzed 298 108 103 87
Mean (95% Confidence Interval)
Unit of Measure: percent change
Day 30 (n= 296, 108, 102, 86)
-57.5
(-59.3 to -55.5)
-50.0
(-53.1 to -46.6)
-64.9
(-67.7 to -61.7)
-61.3
(-64.8 to -57.7)
Day 90 (n=260, 102, 92, 66)
-72.3
(-73.8 to -70.8)
-67.7
(-70.1 to -65.1)
-74.5
(-76.9 to -71.8)
-78.5
(-81.2 to -75.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall
Comments Day 30 assessment
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Effects Poisson Regreesion Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence Rate Ratio
Estimated Value 0.425
Confidence Interval (2-Sided) 95%
0.407 to 0.445
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.023
Estimation Comments Number of observations = 854, Number of participants = 298
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Overall
Comments Day 90 assessment
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Effects Poisson Regression Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence Rate Ratio
Estimated Value 0.277
Confidence Interval (2-Sided) 95%
0.262 to 0.293
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.028
Estimation Comments Number of observations = 854, Number of participants = 298
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Dementia
Comments Day 30 assessment
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Effects Poisson Regression Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence Rate Ratio
Estimated Value 0.500
Confidence Interval (2-Sided) 95%
0.469 to 0.534
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.033
Estimation Comments Number of observations = 318, Number of participants = 108
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Dementia
Comments Day 90 assessment
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Effects Poisson Regression Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence Rate Ratio
Estimated Value 0.323
Confidence Interval (2-Sided) 95%
0.299 to 0.349
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.039
Estimation Comments Number of observations = 318, Number of participants = 108
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Stroke
Comments Day 30 assessment
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Effects Poisson Regression Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence Rate Ratio
Estimated Value 0.351
Confidence Interval (2-Sided) 95%
0.323 to 0.383
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.044
Estimation Comments Number of observations = 297, Number of participants = 103
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Stroke
Comments Day 90 assessment
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Effects Poisson Regression Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence Rate Ratio
Estimated Value 0.255
Confidence Interval (2-Sided) 95%
0.231 to 0.282
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.051
Estimation Comments Number of observations = 297, Number of participants = 103
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Traumatic Brain Injury
Comments Day 30 assessment
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Effects Poisson Regression Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence Rate Ratio
Estimated Value 0.387
Confidence Interval (2-Sided) 95%
0.352 to 0.425
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.048
Estimation Comments Number of observations = 239, Number of participants = 87
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Traumatic Brain Injury
Comments Day 90 assessment
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Effects Poisson Regression Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence Rate Ratio
Estimated Value 0.215
Confidence Interval (2-Sided) 95%
0.189 to 0.245
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.066
Estimation Comments Number of observations = 239, Number of participants = 87
6.Secondary Outcome
Title Percentage of Participants With ≥ 50% Reduction in PBA Episode Count Per Week
Hide Description Data is reported as the percentage of participants with ≥ 50% reduction in PBA episode count/week.
Time Frame Day 30 (Visit 1) and Day 90 (Final visit)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all participants who met all inclusion criteria, including a score of at least 13 on the CNS-LS, who received at least 1 dose of study drug, and who had at least 1 post-baseline efficacy measurement with PBA episode.
Arm/Group Title Overall Dementia Stroke Traumatic Brain Injury
Hide Arm/Group Description:
Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Overall Number of Participants Analyzed 298 108 103 87
Measure Type: Number
Unit of Measure: Percentage of participants
Day 30 (n= 289, 107, 100, 82) 63.7 58.9 65.0 68.3
Day 90 (n= 254, 101, 90, 63) 78.0 76.2 76.7 82.5
7.Secondary Outcome
Title Percentage of Participants With ≥ 75% Reduction in PBA Episode Count Per Week
Hide Description Data is reported as the percentage of participants with ≥ 75% reduction in PBA episode count/week.
Time Frame Day 30 (Visit 1) and Day 90 (Final visit)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all participants who met all inclusion criteria, including a score of at least 13 on the CNS-LS, who received at least 1 dose of study drug, and who had at least 1 post-baseline efficacy measurement with PBA episode.
Arm/Group Title Overall Dementia Stroke Traumatic Brain Injury
Hide Arm/Group Description:
Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Overall Number of Participants Analyzed 298 108 103 87
Measure Type: Number
Unit of Measure: Percentage of participants
Day 30 (n= 289, 107, 100, 82) 42.2 33.6 42.0 53.7
Day 90 (n= 254, 101, 90, 63) 57.1 57.4 47.8 69.8
8.Secondary Outcome
Title Mean Change From Baseline in Quality of Life Visual Analog Scale (QOL-VAS) Score at Day 90
Hide Description 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.
Time Frame Day 90 (Final visit)
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Hide Analysis Population Description
The analysis population consisted of all participants who met all inclusion criteria, including a score of at least 13 on the CNS-LS, who received at least 1 dose of study drug, and who had at least 1 post-baseline efficacy measurement with QOL-VAS.
Arm/Group Title Overall Dementia Stroke Traumatic Brain Injury
Hide Arm/Group Description:
Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Overall Number of Participants Analyzed 298 108 103 87
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-3.13  (3.21) -3.20  (2.98) -2.66  (3.35) -3.67  (3.29)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method One-sample t-test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dementia
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method One-sample t-test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Stroke
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method One-sample t-test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Traumatic Brain Injury
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method One-sample t-test
Comments [Not Specified]
9.Secondary Outcome
Title Percentage of Participants With Clinical Global Impression-Change (CGI-C) Score at Day 90
Hide Description 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.
Time Frame Day 90 (Final visit)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all participants who met all inclusion criteria, including a score of at least 13 on the CNS-LS, who received at least 1 dose of study drug, and who had at least 1 post-baseline efficacy measurement with CGI-C.
Arm/Group Title Overall Dementia Stroke Traumatic Brain Injury
Hide Arm/Group Description:
Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Overall Number of Participants Analyzed 261 102 91 68
Measure Type: Number
Unit of Measure: Percentage of participants
Very much improved 33.7 30.4 33.0 39.7
Much improved 42.9 47.1 41.8 38.2
Minimally improved 13.4 13.7 14.3 11.8
No change 8.8 8.8 7.7 10.3
Minimally worse 0.8 0.0 2.2 0.0
Much worse 0.4 0.0 1.1 0.0
Veru much worse 0.0 0.0 0.0 0.0
10.Secondary Outcome
Title Percentage of Participants With Patient Global Impression-Change (PGI-C) Score at Day 90
Hide Description 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.
Time Frame Day 90 (Final visit)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all participants who met all inclusion criteria, including a score of at least 13 on the CNS-LS, who received at least 1 dose of study drug, and who had at least 1 post-baseline efficacy measurement with PGI-C.
Arm/Group Title Overall Dementia Stroke Traumatic Brain Injury
Hide Arm/Group Description:
Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Overall Number of Participants Analyzed 261 102 92 67
Measure Type: Number
Unit of Measure: Percentage of participants
Very much improved 32.6 28.4 33.7 37.3
Much improved 39.8 48.0 33.7 35.8
Minimally improved 18.8 14.7 21.7 20.9
No change 8.0 7.8 10.9 4.5
Minimally worse 0.4 1.0 0.0 0.0
Much worse 0.4 0.0 0.0 1.5
Veru much worse 0.0 0.0 0.0 0.0
11.Secondary Outcome
Title Percentage of Participants With Treatment Satisfaction Survey
Hide Description 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.
Time Frame Day 90 (Final visit)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The mITT Population consisted of all participants who met all inclusion criteria, including a score of at least 13 on the CNS-LS, who received at least 1 dose of study drug, and who had at least 1 post-baseline efficacy measurement with CNS-LS.
Arm/Group Title Overall Dementia Stroke Traumatic Brain Injury
Hide Arm/Group Description:
Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Overall Number of Participants Analyzed 261 102 92 67
Measure Type: Number
Unit of Measure: Percentage of participants
Very dissatisfied 7.7 4.9 12.0 6.0
Somewhat dissatisfied 5.4 6.9 5.4 3.0
Neither satisfied nor dissatisfied 11.5 13.7 8.7 11.9
Somewhat satisfied 28.0 21.6 31.5 32.8
Very satisfied 47.5 52.9 42.4 46.3
12.Secondary Outcome
Title Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description 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.
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
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Hide Analysis Population Description
The analysis was performed using the safety population that consisted of all enrolled patients who received at least 1 dose of study drug.
Arm/Group Title Overall Dementia Stroke Traumatic Brain Injury
Hide Arm/Group Description:
Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
Overall Number of Participants Analyzed 367 134 113 120
Measure Type: Number
Unit of Measure: Participants
AEs 132 49 40 43
SAEs 23 14 5 4
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
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Overall Dementia Stroke Traumatic Brain Injury
Hide Arm/Group Description Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study. Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study. Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study. Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
All-Cause Mortality
Overall Dementia Stroke Traumatic Brain Injury
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Overall Dementia Stroke Traumatic Brain Injury
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   23/367 (6.27%)   14/134 (10.45%)   5/113 (4.42%)   4/120 (3.33%) 
Cardiac disorders         
Atrial fibrillation  1  1/367 (0.27%)  1/134 (0.75%)  0/113 (0.00%)  0/120 (0.00%) 
Cardiac arrest  1  1/367 (0.27%)  1/134 (0.75%)  0/113 (0.00%)  0/120 (0.00%) 
Myocardial infarction  1  1/367 (0.27%)  0/134 (0.00%)  0/113 (0.00%)  1/120 (0.83%) 
Myocardial ischaemia  1  1/367 (0.27%)  1/134 (0.75%)  0/113 (0.00%)  0/120 (0.00%) 
Gastrointestinal disorders         
Oesophageal stenosis  1  1/367 (0.27%)  1/134 (0.75%)  0/113 (0.00%)  0/120 (0.00%) 
General disorders         
Non-cardiac chest pain  1  1/367 (0.27%)  0/134 (0.00%)  1/113 (0.88%)  0/120 (0.00%) 
Infections and infestations         
Cellulitis  1  1/367 (0.27%)  1/134 (0.75%)  0/113 (0.00%)  0/120 (0.00%) 
Gastroenteritis viral  1  1/367 (0.27%)  1/134 (0.75%)  0/113 (0.00%)  0/120 (0.00%) 
Osteomyelitis  1  1/367 (0.27%)  1/134 (0.75%)  0/113 (0.00%)  0/120 (0.00%) 
Pneumonia  1  1/367 (0.27%)  0/134 (0.00%)  1/113 (0.88%)  0/120 (0.00%) 
Prostate infection  1  1/367 (0.27%)  0/134 (0.00%)  0/113 (0.00%)  1/120 (0.83%) 
Sepsis  1  1/367 (0.27%)  0/134 (0.00%)  0/113 (0.00%)  1/120 (0.83%) 
Urinary tract infection  1  3/367 (0.82%)  1/134 (0.75%)  0/113 (0.00%)  2/120 (1.67%) 
Injury, poisoning and procedural complications         
Facial bones fracture  1  1/367 (0.27%)  0/134 (0.00%)  1/113 (0.88%)  0/120 (0.00%) 
Fall  1  2/367 (0.54%)  1/134 (0.75%)  1/113 (0.88%)  0/120 (0.00%) 
Intentional overdose  1  1/367 (0.27%)  1/134 (0.75%)  0/113 (0.00%)  0/120 (0.00%) 
Subdural haematoma  1  1/367 (0.27%)  1/134 (0.75%)  0/113 (0.00%)  0/120 (0.00%) 
Metabolism and nutrition disorders         
Hyponatraemia  1  1/367 (0.27%)  1/134 (0.75%)  0/113 (0.00%)  0/120 (0.00%) 
Nervous system disorders         
Carotid artery stenosis  1  1/367 (0.27%)  0/134 (0.00%)  1/113 (0.88%)  0/120 (0.00%) 
Cerebrovascular accident  1  1/367 (0.27%)  1/134 (0.75%)  0/113 (0.00%)  0/120 (0.00%) 
Presyncope  1  1/367 (0.27%)  1/134 (0.75%)  0/113 (0.00%)  0/120 (0.00%) 
Toxic encephalopathy  1  1/367 (0.27%)  1/134 (0.75%)  0/113 (0.00%)  0/120 (0.00%) 
Transient ischaemic attack  1  1/367 (0.27%)  0/134 (0.00%)  1/113 (0.88%)  0/120 (0.00%) 
Tremor  1  1/367 (0.27%)  1/134 (0.75%)  0/113 (0.00%)  0/120 (0.00%) 
Psychiatric disorders         
Agitation  1  1/367 (0.27%)  1/134 (0.75%)  0/113 (0.00%)  0/120 (0.00%) 
Depression  1  1/367 (0.27%)  0/134 (0.00%)  0/113 (0.00%)  1/120 (0.83%) 
Mental status changes  1  1/367 (0.27%)  1/134 (0.75%)  0/113 (0.00%)  0/120 (0.00%) 
Paranoia  1  1/367 (0.27%)  1/134 (0.75%)  0/113 (0.00%)  0/120 (0.00%) 
Suicidal ideation  1  1/367 (0.27%)  0/134 (0.00%)  0/113 (0.00%)  1/120 (0.83%) 
Respiratory, thoracic and mediastinal disorders         
Pneumonia aspiration  1  1/367 (0.27%)  0/134 (0.00%)  1/113 (0.88%)  0/120 (0.00%) 
Respiratory failure  1  1/367 (0.27%)  1/134 (0.75%)  0/113 (0.00%)  0/120 (0.00%) 
Vascular disorders         
Deep vein thrombosis  1  1/367 (0.27%)  1/134 (0.75%)  0/113 (0.00%)  0/120 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Overall Dementia Stroke Traumatic Brain Injury
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   35/367 (9.54%)   15/134 (11.19%)   9/113 (7.96%)   11/120 (9.17%) 
Gastrointestinal disorders         
Diarrhoea  1  20/367 (5.45%)  5/134 (3.73%)  5/113 (4.42%)  10/120 (8.33%) 
Nervous system disorders         
Headache  1  15/367 (4.09%)  10/134 (7.46%)  4/113 (3.54%)  1/120 (0.83%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Name/Title: Nadine Knowles; Executive Director, Research & Development Operations
Organization: Avanir Pharmaceuticals
Phone: 1-949-268-8972
Responsible Party: Avanir Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01799941     History of Changes
Other Study ID Numbers: 12-AVR-401
First Submitted: February 25, 2013
First Posted: February 27, 2013
Results First Submitted: May 5, 2016
Results First Posted: March 15, 2017
Last Update Posted: March 15, 2017