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

Stroke Clinical Trial

— PRISM II  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01799941
• Other study ID #: 12-AVR-401
• Status: Active, not recruiting
• Phase: Phase 4
• First received: February 25, 2013
• Last updated: December 18, 2015
• Start date: February 2013
• Est. completion date: December 2015

Study information

• Verified date: February 2015
• Source: Avanir Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 750
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dementia
• Pseudobulbar Affect (PBA)
• Stroke
• Traumatic Brain Injury (TBI)

Intervention

Drug:
• Nuedexta (DM 20 mg/Q 10 mg)
Single Arm, Open-Label Dosing with Nuedexta (DM 20 mg/Q 10 mg)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Avanir Pharmaceuticals	OptumInsight Life Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy endpoint is the mean change from baseline at 12 weeks in CNS-LS score.	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.	12 weeks	No
Secondary	Safety and Tolerability	Assessments to include Patient History, Medication History,Concomitant Medication and Adverse Events.	12 weeks	Yes
Secondary	PBA Episode Counts	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.	12 weeks	No
Secondary	Patient Global Impression-Change (PGI-C)	A 7-point (1-7) scale, where a patient/patient's caregiver assesses the patient's overall treatment response.	12 Weeks	No
Secondary	Clinical Global Impression-Change (CGI-C)	The CGI-C is a 7-point (1-7) scale and is an investigator-rated scale to assess the overall treatment response.	12 Weeks	No
Secondary	Patient Satisfaction with Treatment Survey	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.	12 Weeks	No