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NCT01630811 · ClinicalTrials.gov registry record · Phase 2

Nuedexta for the Treatment of Adults With Autism

A Phase 2 study, sponsored by Sutter Health.

Completed
Registry status
Phase 2
Development phase
13
Enrollment target

NCT01630811: Completed Phase 2 study, sponsored by Sutter Health.

NCT01630811 is a Phase 2 study that has completed, run by Sutter Health. The registered enrollment target is 13 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01630811, a Phase 2 study, has completed, sponsored by Sutter Health.

COMPLETED
Registry status
Phase 2
Development phase
13 participants
Enrollment target

Study 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).

Primary Outcome

Demonstrate a change in 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. This checklist consists of 20 questions relating to behavior and the reported total score is on a scale from 0 to 60. A lower score can be interpreted as less frequent and/or less intense presentation of the undesirable behavior. The below values are the difference in ABC scores from bas

Interventions

  • OTHER Placebo
  • DRUG Nuedexta

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2012-01-24
Est. Completion 2015-12-15
Phase Phase 2
Sutter Health

9 total trials

What the finished NCT01630811 record still lists

NCT01630811 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01630811 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01630811 about?

NCT01630811 is a clinical study titled "Nuedexta for the Treatment of Adults With Autism". 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 ...

What is the current status of trial NCT01630811?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2012-01-24. Estimated completion is 2015-12-15.

What interventions are being tested in trial NCT01630811?

The interventions under investigation include: Placebo (OTHER), Nuedexta (DRUG).

Who is sponsoring clinical trial NCT01630811?

This trial is sponsored by Sutter Health, which has 9 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01630811's enrollment target sits among peer trials

13 1947th of 2000 higher than 53 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01630811, the US trial registry maintained by the National Library of Medicine. NCT01630811 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.