NCT01630811

Nuedexta for the Treatment of Adults With Autism

Nuedexta for Neurobehavioral Symptoms of Adults With Autism Spectrum Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Sutter Health · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed 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.

Conditions

• Autism

Interventions

Type	Name	Description
DRUG	Nuedexta	Nuedexta (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.
OTHER	Placebo	Placebo will be given once daily for 7 days.

Timeline

• Start date: 2012-01-24
• Primary completion: 2015-12-15
• Completion: 2015-12-15
• First posted: 2012-06-28
• Last updated: 2017-12-08
• Results posted: 2017-12-08

Locations

1 site across 1 country: United States