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

Completed · Phase 4

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

In brief

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.

Key facts

Study ID

NCT01799941

Run by

Avanir Pharmaceuticals

People needed

367

Starts

2013-02-01

Expected to finish

2015-05-01

Last updated by the study team

2017-03-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Unstable neurologic disease
• Severe dementia
• Stroke within 3 months
• Penetrating TBI
• Contraindications to Nuedexta
• Severe Depressive Disorder

Where it is running

• Study site — Pensacola, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.