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Generated: December 10, 2018

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CLINICAL TRIALS PROFILE FOR NUEDEXTA

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Clinical Trials for Nuedexta

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

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Clinical Trial Conditions for Nuedexta

Condition Name

Condition Name for Nuedexta
Intervention Trials
Pseudobulbar Affect (PBA) 2
Major Depressive Disorder 2
Traumatic Brain Injury (TBI) 1
Autism 1
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Condition MeSH

Condition MeSH for Nuedexta
Intervention Trials
Depression 2
Depressive Disorder, Major 2
Depressive Disorder 2
Brain Injuries 1
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Clinical Trial Locations for Nuedexta

Trials by Country

Trials by Country for Nuedexta
Location Trials
United States 17
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Trials by US State

Trials by US State for Nuedexta
Location Trials
Ohio 2
Florida 2
California 2
New York 2
Oregon 1
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Clinical Trial Progress for Nuedexta

Clinical Trial Phase

Clinical Trial Phase for Nuedexta
Clinical Trial Phase Trials
Phase 4 3
Phase 2 4
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for Nuedexta
Clinical Trial Phase Trials
Active, not recruiting 4
Completed 2
Terminated 1
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Clinical Trial Sponsors for Nuedexta

Sponsor Name

Sponsor Name for Nuedexta
Sponsor Trials
Avanir Pharmaceuticals 4
OptumInsight Life Sciences 1
James Murrough 1
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Sponsor Type

Sponsor Type for Nuedexta
Sponsor Trials
Other 9
Industry 4
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