Primary: Demonstrate reduced frequency and intensity of maladaptive behaviors as measured by
the Aberrant Behavior Checklist (ABC) Irritability subscale in subjects given Nuedexta 8
weeks over subjects given placebo.
Secondary: Demonstrate a trend towards reduced aggressive behavior as measured by Overt
Aggression Scale (OAS).
Safety, Tolerability and Effectiveness of Nuedexta in the Treatment of Pseudobulbar Affect (PBA)
Completed
OptumInsight Life Sciences
Phase 4
2013-02-01
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.
Safety, Tolerability and Effectiveness of Nuedexta in the Treatment of Pseudobulbar Affect (PBA)
Completed
Avanir Pharmaceuticals
Phase 4
2013-02-01
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.
The purpose of this study is to determine whether Nuedexta is effective in the treatment of
symptoms (impaired speech, swallowing, and saliva control)associated with Amyotrophic Lateral
Sclerosis (ALS).
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