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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
Sponsor:
Information provided by (Responsible Party):
Michael Chez, MD, Sutter Health

Tracking Information
First Submitted Date  ICMJE June 26, 2012
First Posted Date  ICMJE June 28, 2012
Results First Submitted Date  ICMJE November 4, 2016
Results First Posted Date  ICMJE December 8, 2017
Last Update Posted Date December 8, 2017
Actual Study Start Date  ICMJE January 24, 2012
Actual Primary Completion Date December 15, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2017)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: June 27, 2012)
Reduction in Maladaptive Behaviors [ Time Frame: 44 weeks ]
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.
Change History Complete list of historical versions of study NCT01630811 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2017)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2012)
  • Reduction in Aggressive Behavior [ Time Frame: 44 weeks ]
    Demonstrate a trend towards reduced aggressive behavior as measured by Overt Aggression Scale (OAS).
  • Safety and Tolerability [ Time Frame: 44 weeks ]
    Safety and tolerability will be assessed through monitoring of cardiac, renal and liver function.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nuedexta for the Treatment of Adults With Autism
Official Title  ICMJE Nuedexta for Neurobehavioral Symptoms of Adults With Autism Spectrum Disorder
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Autism
Intervention  ICMJE
  • 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 Name: Dextromethorphan hydrobromide and quinidine sulfate
  • Other: Placebo
    Placebo will be given once daily for 7 days.
Study Arms  ICMJE
  • Experimental: Nuedexta
    Nuedexta (Dextromethorphan hydrobromide 20 mg/quinidine sulfate 10 mg), oral, once daily
    Intervention: Drug: Nuedexta
  • Placebo Comparator: Placebo
    Oral, once daily
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 4, 2017)
13
Original Estimated Enrollment  ICMJE
 (submitted: June 27, 2012)
20
Actual Study Completion Date  ICMJE December 15, 2015
Actual Primary Completion Date December 15, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 18 to 60 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 the Diagnostic and Statistical Manual, 4th edition, Text Revised (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. No medication changes within 30 days and no use of new medications during the course of the study except for non-related conditions approved by the investigators

Exclusion Criteria:

  1. Clinically uncontrolled epilepsy
  2. Cardiovascular conditions including cardiac or structural malformation heart failure, prolonged QT interval, history of torsades de pointes, or atrioventricular (AV) block
  3. Known genetic disorders, fragile x, or known brain structural abnormalities, cerebral palsy, head injury, or brain tumor
  4. Known allergy to either dextromethorphan or quinidine
  5. Concurrent or recent use of Monoamine oxidase inhibitor (MAOI) antidepressants pt Nuedexta
  6. Concurrent use of lamotrigine or felbamate or other N-Methyl-D-aspartate (NMDA) agonists or antagonists
  7. Thrombocytopenia, hepatitis, bone marrow depression or lupus-like syndrome
  8. Pregnancy - sexually active females of childbearing potential must be on a reliable form of contraception
  9. Other clinically significant abnormality on physical, neurological, laboratory, vital signs, that could compromise the study or be detrimental to the subject
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01630811
Other Study ID Numbers  ICMJE CHKI-Nued0911
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Chez, MD, Sutter Health
Study Sponsor  ICMJE Sutter Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael G Chez, MD Sutter Health
Study Director: Carol A Parise, PhD Sutter Health
PRS Account Sutter Health
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP