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CLINICAL TRIALS PROFILE FOR NUEDEXTA

All Clinical Trials for NUEDEXTA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01630811 ↗	Nuedexta for the Treatment of Adults With Autism	Completed	Sutter Health	Phase 2	2012-01-24	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)	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.
NCT01799941 ↗	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.
NCT01806857 ↗	Clinical Trial Nuedexta in Subjects With ALS	Completed	ALS Association	Phase 2	2013-04-01	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	2013-04-01	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	2013-04-01	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	Terminated	Avanir Pharmaceuticals	Phase 4	2012-08-28	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).

Clinical Trial Conditions for NUEDEXTA

Condition Name

Condition Name for NUEDEXTA
Intervention	Trials
Major Depressive Disorder	3
Pseudobulbar Affect (PBA)	2
Dementia	1
Episodic Migraine	1

Condition MeSH

Condition MeSH for NUEDEXTA
Intervention	Trials
Depressive Disorder, Major	3
Depressive Disorder	3
Depression	3
Motor Neuron Disease	2

Clinical Trial Locations for NUEDEXTA

Trials by Country

Trials by Country for NUEDEXTA
Location	Trials
United States	19

Trials by US State

Trials by US State for NUEDEXTA
Location	Trials
Florida	3
California	2
New York	2
Ohio	2
Michigan	1

Clinical Trial Progress for NUEDEXTA

Clinical Trial Phase

Clinical Trial Phase for NUEDEXTA
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	1
Phase 2	4

Clinical Trial Status

Clinical Trial Status for NUEDEXTA
Clinical Trial Phase	Trials
Completed	6
Terminated	2
Not yet recruiting	1

Clinical Trial Sponsors for NUEDEXTA

Sponsor Name

Sponsor Name for NUEDEXTA
Sponsor	Trials
Avanir Pharmaceuticals	4
ALS Association	2
Cures Within Reach	1

Sponsor Type

Sponsor Type for NUEDEXTA
Sponsor	Trials
Other	15
Industry	4