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Nuedexta for the Treatment of Adults With Autism (Nuedexta)

Primary Purpose

Autism

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Nuedexta

Placebo

About this trial

This is an interventional treatment trial for Autism focused on measuring Adults

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18 to 60 years of age
Have a collateral informant who can attend visit and answer questionnaires pertaining to participant behavior
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
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
Mood issues and frontal lobe type perseveration issues
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:

Clinically uncontrolled epilepsy
Cardiovascular conditions including cardiac or structural malformation heart failure, prolonged QT interval, history of torsades de pointes, or atrioventricular (AV) block
Known genetic disorders, fragile x, or known brain structural abnormalities, cerebral palsy, head injury, or brain tumor
Known allergy to either dextromethorphan or quinidine
Concurrent or recent use of Monoamine oxidase inhibitor (MAOI) antidepressants pt Nuedexta
Concurrent use of lamotrigine or felbamate or other N-Methyl-D-aspartate (NMDA) agonists or antagonists
Thrombocytopenia, hepatitis, bone marrow depression or lupus-like syndrome
Pregnancy - sexually active females of childbearing potential must be on a reliable form of contraception
Other clinically significant abnormality on physical, neurological, laboratory, vital signs, that could compromise the study or be detrimental to the subject

Sites / Locations

Sutter Pediatric Neurology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nuedexta

Placebo

Arm Description

Nuedexta (Dextromethorphan hydrobromide 20 mg/quinidine sulfate 10 mg), oral, once daily

Oral, once daily

Outcomes

Primary Outcome Measures

Change in Maladaptive Behaviors

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

Number of serious adverse events

Secondary Outcome Measures

Change in Aggressive Behavior

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.

Full Information

NCT ID

NCT01630811

First Posted

June 26, 2012

Last Updated

November 4, 2017

Sponsor

Sutter Health

1. Study Identification

Unique Protocol Identification Number

NCT01630811

Brief Title

Nuedexta for the Treatment of Adults With Autism

Acronym

Nuedexta

Official Title

Nuedexta for Neurobehavioral Symptoms of Adults With Autism Spectrum Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

January 24, 2012 (Actual)

Primary Completion Date

December 15, 2015 (Actual)

Study Completion Date

December 15, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sutter Health

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autism

Keywords

Adults

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nuedexta

Arm Type

Experimental

Arm Description

Nuedexta (Dextromethorphan hydrobromide 20 mg/quinidine sulfate 10 mg), oral, once daily

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Oral, once daily

Intervention Type

Drug

Intervention Name(s)

Nuedexta

Other Intervention Name(s)

Dextromethorphan hydrobromide and quinidine sulfate

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo will be given once daily for 7 days.

Primary Outcome Measure Information:

Title

Change in Maladaptive Behaviors

Description

Time Frame

Baseline and 8 weeks

Title

Primary Safety Endpoints

Description

Number of serious adverse events

Time Frame

Week 0 through week 25

Secondary Outcome Measure Information:

Title

Change in Aggressive Behavior

Description

Time Frame

Baseline and 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 to 60 years of age Have a collateral informant who can attend visit and answer questionnaires pertaining to participant behavior 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 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 Mood issues and frontal lobe type perseveration issues 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: Clinically uncontrolled epilepsy Cardiovascular conditions including cardiac or structural malformation heart failure, prolonged QT interval, history of torsades de pointes, or atrioventricular (AV) block Known genetic disorders, fragile x, or known brain structural abnormalities, cerebral palsy, head injury, or brain tumor Known allergy to either dextromethorphan or quinidine Concurrent or recent use of Monoamine oxidase inhibitor (MAOI) antidepressants pt Nuedexta Concurrent use of lamotrigine or felbamate or other N-Methyl-D-aspartate (NMDA) agonists or antagonists Thrombocytopenia, hepatitis, bone marrow depression or lupus-like syndrome Pregnancy - sexually active females of childbearing potential must be on a reliable form of contraception Other clinically significant abnormality on physical, neurological, laboratory, vital signs, that could compromise the study or be detrimental to the subject

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael G Chez, MD

Organizational Affiliation

Sutter Health

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Carol A Parise, PhD

Organizational Affiliation

Sutter Health

Official's Role

Study Director

Facility Information:

Facility Name

Sutter Pediatric Neurology

City

Sacramento

State/Province

California

ZIP/Postal Code

95816

Country

United States

12. IPD Sharing Statement

Links:

URL

http://checksutterfirst.org/research

Description

Sutter Health Research

Learn more about this trial

Nuedexta for the Treatment of Adults With Autism

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