Brief Summary

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Official Title: "Nuedexta for Neurobehavioral Symptoms of Adults With Autism Spectrum Disorder"

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).

• Study Type: Interventional
• Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
• Study Primary Completion Date: June 2013

Detailed Clinical Trial Description

This is a randomized placebo-controlled crossover study. The parents, neuropsychologists, clinical research coordinator (CRC) and PI will be blinded as to whether subjects are on placebo or Nuedexta.

Nuedexta will be given once daily for 7 days. If well-tolerated, it will be given every 12 hours for the next 7 weeks. Patients may also remain on the once-daily dose if desired.

The study will last 44 weeks. This includes 20 weeks for study enrollment, 8 weeks of treatment/placebo, 4 weeks for washout, and a second 8 week-period of treatment/placebo followed by 4 weeks of washout.

Subjects will be randomized to 8 weeks of Nuedexta/placebo. After the 8 week follow-up visit, there will be a 4 week washout period. At week 12 (second baseline), the groups will crossover for another 8 weeks of Nuedexta/placebo. Study endpoints will be measured in the both groups at weeks 8, 12, and 20. A final study visit will occur at week 24.

Interventions Used in this Clinical Trial

• Drug: Nuedexta
  • Neudexta (Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg) will be given once daily for 7 days. If well-tolerated, it will be given every 12 hours for the next 7 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Nuedexta
• Placebo Comparator: Placebo

Outcome Measures for this Clinical Trial

Primary Measures

• Reduction in Maladaptive Behaviors
  • Time Frame: 44 weeks
    Safety Issue?: No

Secondary Measures

• Reduction in Aggressive Behavior
  • Time Frame: 44 weeks
    Safety Issue?: No
• Safety and Tolerability
  • Time Frame: 44 weeks
    Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

Inclusion Criteria

1. 18 to 50 years of age

2. Have a collateral informant who can attend visit and answer questionnaires pertaining to participant behavior

3. Diagnosis of autistic spectrum disorder based on DSM-IV-TR criteria, developmental history, and Autism Diagnostic Observation Schedule (ADOS); or confirmed diagnosis of autism during childhood through similar methods

4. 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

5. Mood issues and frontal lobe type perseveration issues

6. Eligible for administration of ADOS module 2, 3 or 4 which indicates verbal fluency

7. Stable on any current medication(s) for 2 months

8. Refrain from medications that contain dextromethorphan

Exclusion Criteria

1. Clinically uncontrolled epilepsy

2. Cardiac rhythm or structural malformation

3. Known genetic disorders including fragile x, and other confounding factors (e.g., cerebral palsy, head injury, brain tumor)

4. Known allergy to either dextromethorphan or quinidine

5. Concurrent or recent use of Monoamine oxidase inhibitor (MAOI) antidepressants

6. Current use of Nuedexta

7. Cardiovascular conditions including heart failure, prolonged QT interval, congenital long QT syndrome, history of torsades de pointes, complete atrioventricular block (AV block) or at risk of AV block

8. Thrombocytopenia, hepatitis, bone marrow depression or lupus-like syndrome

9. Concurrent use of drugs that both prolong QT intervals and are metabolized by Cytochrome P450 2D6 (CYP2D6)

10. Pregnancy - females of childbearing potential must be on a reliable form of contraception

11. Concurrent use of lamotrigine or felbamate or other N-Methyl-D-aspartate (NMDA) agonists or antagonists

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

• Lead Sponsor
  • Sutter Health
• Provider of Information About this Clinical Study
  • Principal Investigator: Michael Chez, MD, Principal Investigator - Sutter Health
• Overall Official(s)
  • Michael G Chez, MD, Principal Investigator, Sutter Health
  • Carol A Parise, PhD, Study Director, Sutter Health
• Overall Contact(s)
  • Bobbie Benabides, BA, (916) 454-6924, BenaBib@sutterhealth.org