CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 13 enrolled
Drug / intervention
Nuedexta +1 moredrug
Likely dose
Nuedexta 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01630811
NCT01630811Phase 2Completed
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Nuedexta for Neurobehavioral Symptoms of Adults With Autism Spectrum Disorder

Sutter Health·interventional·Posted Jun 28, 2012·Updated Dec 8, 2017

In Brief

A Phase 2 clinical trial evaluating Nuedexta and Placebo for Autism. Completed, enrolled 13 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutism
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 28, 2012
Enrollment StartJan 24, 2012
Primary CompletionDec 15, 2015
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 14.0 years ago

Interventions

Nuedextadrug

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.

Placeboother

Placebo will be given once daily for 7 days.