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

This study is ongoing, but not recruiting participants.
OptumInsight Life Sciences
Information provided by (Responsible Party):
Avanir Pharmaceuticals Identifier:
First received: February 25, 2013
Last updated: December 18, 2015
Last verified: February 2015
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 PBA in patients with prevalent conditions such as dementia, stroke and traumatic brain injury over a 12 week period.

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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:

Further study details as provided by Avanir Pharmaceuticals:

Primary Outcome Measures:
  • The primary efficacy endpoint is the mean change from baseline at 12 weeks in CNS-LS score. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.

Secondary Outcome Measures:
  • Safety and Tolerability [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Assessments to include Patient History, Medication History,Concomitant Medication and Adverse Events.

  • PBA Episode Counts [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Patient Global Impression-Change (PGI-C) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    A 7-point (1-7) scale, where a patient/patient's caregiver assesses the patient's overall treatment response.

  • Clinical Global Impression-Change (CGI-C) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    The CGI-C is a 7-point (1-7) scale and is an investigator-rated scale to assess the overall treatment response.

  • Patient Satisfaction with Treatment Survey [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    The Patient treatment satisfaction survey is a 5 point single question survey that will be administered by the site staff to the patient/patient's caregiver.

Estimated Enrollment: 750
Study Start Date: February 2013
Estimated Study Completion Date: December 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 CNS Lability scale (CNS-LS). Secondary objectives include measures to evaluate treatment outcomes.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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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Please refer to this study by its identifier: NCT01799941

United States, Florida
Pensacola, Florida, United States, 32503
Sponsors and Collaborators
Avanir Pharmaceuticals
OptumInsight Life Sciences
  More Information

Responsible Party: Avanir Pharmaceuticals Identifier: NCT01799941     History of Changes
Other Study ID Numbers: 12-AVR-401 
Study First Received: February 25, 2013
Last Updated: December 18, 2015
Health Authority: United States: Food and Drug Administration processed this record on May 26, 2016