Nuedexta for the Treatment of Adults With Autism

Completed · Phase 2 · Has a placebo group

Conditions studied: Autism

In brief

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).

Key facts

Study ID

NCT01630811

Run by

Sutter Health

People needed

13

Starts

2012-01-24

Expected to finish

2015-12-15

Last updated by the study team

2017-12-08

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 to 60 years of age
• Have a collateral informant who can attend visit and answer questionnaires pertaining to participant behavior
• Diagnosis of autistic spectrum disorder based on the Diagnostic and Statistical Manual, 4th edition, Text Revised (DSM-IV-TR) criteria, developmental history, and Autism Diagnostic Observation Schedule (ADOS); or confirmed diagnosis of autism during childhood through similar methods
• Capable of giving informed consent, or have a legal guardian capable of giving consent on the subject's behalf; patient able to assent to participate
• Mood issues and frontal lobe type perseveration issues
• No medication changes within 30 days and no use of new medications during the course of the study except for non-related conditions approved by the investigators

You may not qualify if…

• Clinically uncontrolled epilepsy
• Cardiovascular conditions including cardiac or structural malformation heart failure, prolonged QT interval, history of torsades de pointes, or atrioventricular (AV) block
• Known genetic disorders, fragile x, or known brain structural abnormalities, cerebral palsy, head injury, or brain tumor
• Known allergy to either dextromethorphan or quinidine
• Concurrent or recent use of Monoamine oxidase inhibitor (MAOI) antidepressants pt Nuedexta
• Concurrent use of lamotrigine or felbamate or other N-Methyl-D-aspartate (NMDA) agonists or antagonists
• Thrombocytopenia, hepatitis, bone marrow depression or lupus-like syndrome
• Pregnancy - sexually active females of childbearing potential must be on a reliable form of contraception
• Other clinically significant abnormality on physical, neurological, laboratory, vital signs, that could compromise the study or be detrimental to the subject

Where it is running

• Sutter Pediatric Neurology — Sacramento, California, United States

Full record on ClinicalTrials.gov

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