Nuedexta for the Treatment of Adults With Autism (Nuedexta)
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|ClinicalTrials.gov Identifier: NCT01630811|
Recruitment Status : Completed
First Posted : June 28, 2012
Results First Posted : December 8, 2017
Last Update Posted : December 8, 2017
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).
|Condition or disease||Intervention/treatment||Phase|
|Autism||Drug: Nuedexta Other: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Nuedexta for Neurobehavioral Symptoms of Adults With Autism Spectrum Disorder|
|Actual Study Start Date :||January 24, 2012|
|Actual Primary Completion Date :||December 15, 2015|
|Actual Study Completion Date :||December 15, 2015|
Nuedexta (Dextromethorphan hydrobromide 20 mg/quinidine sulfate 10 mg), oral, once daily
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 Name: Dextromethorphan hydrobromide and quinidine sulfate
Placebo Comparator: Placebo
Oral, once daily
Placebo will be given once daily for 7 days.
- Change in Maladaptive Behaviors [ Time Frame: Baseline and 8 weeks ]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 baseline to 8 weeks. A negative difference indicates improved behavior.
- Primary Safety Endpoints [ Time Frame: Week 0 through week 25 ]Number of serious adverse events
- Change in Aggressive Behavior [ Time Frame: Baseline and 8 weeks ]Demonstrate a trend towards reduced aggressive behavior as measured by Overt Aggression Scale (OAS). It consists of a scale from 0 - 40, and a lower score can be interpreted as less frequent and/or less intense presentation of the undesirable behavior. Reported is the mean difference in scores from baseline to 8 weeks. A positive score indicates more aggressive behavior and a negative score indicates less aggressive behavior.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01630811
|United States, California|
|Sutter Pediatric Neurology|
|Sacramento, California, United States, 95816|
|Principal Investigator:||Michael G Chez, MD||Sutter Health|
|Study Director:||Carol A Parise, PhD||Sutter Health|