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

Avanir Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Stroke; Pseudobulbar Affect (PBA); Traumatic Brain Injury (TBI); Dementia

Treatments: Drug: Nuedexta (DM 20 mg/Q 10 mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01799941

12-AVR-401

Details and patient eligibility

About

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 Pseudobulbar Affect (PBA) in patients with prevalent conditions such as dementia, stroke, and traumatic brain injury (TBI)over a 12 week period.

Full 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 Center for Neurologic Study-Lability scale (CNS-LS). Secondary objectives include measures to evaluate treatment outcomes.

Enrollment: 367 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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367 participants in 1 patient group

Nuedexta (DM 20 mg/Q 10 mg)

Other group

Description:

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

Treatment:

Drug: Nuedexta (DM 20 mg/Q 10 mg)