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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).

Clinical Trial Conditions for NUEDEXTA

Condition Name

Condition Name for NUEDEXTA
Intervention	Trials
Major Depressive Disorder	3
Pseudobulbar Affect (PBA)	2
Amyotrophic Lateral Sclerosis	1
Traumatic Brain Injury (TBI)	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
Recruiting	1

Clinical Trial Sponsors for NUEDEXTA

Sponsor Name

Sponsor Name for NUEDEXTA
Sponsor	Trials
Avanir Pharmaceuticals	4
ALS Association	2
The University of Texas Health Science Center, Houston	1

Sponsor Type

Sponsor Type for NUEDEXTA
Sponsor	Trials
Other	15
Industry	4