This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Avanir Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01799941
First received: February 25, 2013
Last updated: January 26, 2017
Last verified: January 2017
Results First Received: May 5, 2016  
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)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Dextromethorphan Hydrobromide 20 mg + Quinidine Sulfate 10 mg 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.

Participant Flow:   Overall Study
    Dextromethorphan Hydrobromide 20 mg + Quinidine Sulfate 10 mg
STARTED   367 
COMPLETED   271 
NOT COMPLETED   96 
Adverse Event                34 
Withdrawal by Subject                21 
Death                2 
Investigator Decision                4 
Lack of Efficacy                3 
Lost to Follow-up                17 
Not Specified                15 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Dextromethorphan Hydrobromide 20 mg + Quinidine Sulfate 10 mg 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.

Baseline Measures
   Dextromethorphan Hydrobromide 20 mg + Quinidine Sulfate 10 mg 
Overall Participants Analyzed 
[Units: Participants]
 367 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      215  58.6% 
>=65 years      152  41.4% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      202  55.0% 
Male      165  45.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Change From Baseline in Center for Neurologic Study-Lability Scale (CNS-LS) Score at Day 90   [ Time Frame: Day 90 (Final visit) ]

2.  Secondary:   Mean Change From Baseline in Center for Neurologic Study-Lability Scale (CNS-LS) Score at Day 30   [ Time Frame: Day 30 ]

3.  Secondary:   Mean Pseudobulbar Affect (PBA) Episode Count Per Week by Visit   [ Time Frame: Baseline (Day 1), Day 30 (Visit 1), and Day 90 (Final visit) ]

4.  Secondary:   Percentage of Participants With PBA Remission   [ Time Frame: Day 30 (Visit 1) and Day 90 (Final visit) ]

5.  Secondary:   Percentage Change From Baseline in PBA Episode Count Per Week   [ Time Frame: Day 30 (Visit 1) and Day 90 (Final visit) ]

6.  Secondary:   Percentage of Participants With ≥ 50% Reduction in PBA Episode Count Per Week   [ Time Frame: Day 30 (Visit 1) and Day 90 (Final visit) ]

7.  Secondary:   Percentage of Participants With ≥ 75% Reduction in PBA Episode Count Per Week   [ Time Frame: Day 30 (Visit 1) and Day 90 (Final visit) ]

8.  Secondary:   Mean Change From Baseline in Quality of Life Visual Analog Scale (QOL-VAS) Score at Day 90   [ Time Frame: Day 90 (Final visit) ]

9.  Secondary:   Percentage of Participants With Clinical Global Impression-Change (CGI-C) Score at Day 90   [ Time Frame: Day 90 (Final visit) ]

10.  Secondary:   Percentage of Participants With Patient Global Impression-Change (PGI-C) Score at Day 90   [ Time Frame: Day 90 (Final visit) ]

11.  Secondary:   Percentage of Participants With Treatment Satisfaction Survey   [ Time Frame: Day 90 (Final visit) ]

12.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Nadine Knowles; Executive Director, Research & Development Operations
Organization: Avanir Pharmaceuticals
phone: 1-949-268-8972
e-mail: nknowles@avanir.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Avanir Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01799941     History of Changes
Other Study ID Numbers: 12-AVR-401
Study First Received: February 25, 2013
Results First Received: May 5, 2016
Last Updated: January 26, 2017