Trial record 1 of 9 for:    PRISM-II
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Safety, Tolerability and Effectiveness of Nuedexta in the Treatment of Pseudobulbar Affect (PBA) (PRISM II)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Avanir Pharmaceuticals
Sponsor:
Collaborator:
OptumInsight Life Sciences
Information provided by (Responsible Party):
Avanir Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01799941
First received: February 25, 2013
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

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)
Stroke
Dementia
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 2014
Estimated Primary Completion Date: October 2014 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01799941

Contacts
Contact: Fred Ledon (949) 389-6724 pshin@avanir.com
Contact: Paul Shin (949) 268-5930 pshin@avanir.com

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

No publications provided

Responsible Party: Avanir Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01799941     History of Changes
Other Study ID Numbers: 12-AVR-401
Study First Received: February 25, 2013
Last Updated: March 13, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 01, 2014