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

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Avanir Pharmaceuticals
• Collaborator: OptumInsight Life Sciences
• Treatments: Dextromethorphan; Quinidine

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