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

February 25, 2013
March 13, 2014
February 2013
October 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01799941 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
  • Other Patient Reported Outcomes [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Includes Patient Global Impression-Change (PGI-C), which is a 7-point (1-7) scale, where a patient/patient's caregiver assesses the patient's overall treatment response, and the Patient Satisfaction with Treatment Survey, which is a 5 point single question survey that will be administered by the site staff to the patient/patient's caregiver.
Not Provided
Not Provided
 
Safety, Tolerability and Effectiveness of Nuedexta in the Treatment of Pseudobulbar Affect (PBA)
A Study to Assess the Safety, Tolerability and Effectiveness of Nuedexta (Dextromethorphan 20 mg/Quinidine 10 mg) in the Treatment of Pseudobulbar Affect (PBA)

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.

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.

Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pseudobulbar Affect (PBA)
  • Stroke
  • Dementia
  • Traumatic Brain Injury (TBI)
Drug: Nuedexta (DM 20 mg/Q 10 mg)
Single Arm, Open-Label Dosing with Nuedexta (DM 20 mg/Q 10 mg)
Other Name: Nuedexta
Nuedexta (DM 20 mg/Q 10 mg)
Single Arm, Open Label Dosing with Nuedexta (DM 20 mg/Q 10 mg)
Intervention: Drug: Nuedexta (DM 20 mg/Q 10 mg)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
750
December 2014
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Fred Ledon (949) 389-6724 pshin@avanir.com
Contact: Paul Shin (949) 268-5930 pshin@avanir.com
United States
 
NCT01799941
12-AVR-401
No
Avanir Pharmaceuticals
Avanir Pharmaceuticals
OptumInsight Life Sciences
Not Provided
Avanir Pharmaceuticals
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP