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CLINICAL TRIALS PROFILE FOR NUEDEXTA

Clinical Trials for Nuedexta

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Trial ID	Title	Status	Sponsor	Phase	Summary
NCT01630811	Nuedexta for the Treatment of Adults With Autism	Active, not recruiting	Sutter Health	Phase 2	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).
NCT01799941	Safety, Tolerability and Effectiveness of Nuedexta in the Treatment of Pseudobulbar Affect (PBA)	Active, not recruiting	OptumInsight Life Sciences	Phase 4	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.
NCT01799941	Safety, Tolerability and Effectiveness of Nuedexta in the Treatment of Pseudobulbar Affect (PBA)	Active, not recruiting	Avanir Pharmaceuticals	Phase 4	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.
NCT01806857	Clinical Trial Nuedexta in Subjects With ALS	Completed	ALS Association	Phase 2	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).
NCT01806857	Clinical Trial Nuedexta in Subjects With ALS	Completed	State University of New York - Upstate Medical University	Phase 2	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).
NCT01806857	Clinical Trial Nuedexta in Subjects With ALS	Completed	Center for Neurologic Study, La Jolla, California,	Phase 2	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).
NCT01832350	Nuedexta in the Treatment of Pseudobulbar Affect in Patients With Alzheimer's Disease	Active, not recruiting	Avanir Pharmaceuticals	Phase 4	The primary objective of this study is to test the hypothesis that Nuedexta (20/10) administered orally will reduce Pseudobulbar Affect (PBA) frequency and severity (CNS-Lability Scale and PLACS), with satisfactory safety and high tolerability in patients with Alzheimer's Disease (AD). The primary objective will be evaluated using a study endpoint at 1, 13, 26 weeks after initiation of treatment. The secondary objective of this study is to evaluate the benefit of treatment with Nuedexta (20/10) on cognition and functionality as demonstrated in the Rey Auditory Verbal Learning Test (RAVLT), Trail making A and B, Wechsler Memory Scale (WMS) logical memory and delayed recall, Controlled Oral Word Association (COWA), Clinical Dementia Rating (CDR), Neuropsychiatric Inventory (NPI), Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCSADL) and the 11-item Alzheimer's Disease Assessment Scale-Cognitive subscore (ADAS-Cog11).
Trial ID	Title	Status	Sponsor	Phase	Summary