Nuedexta for the Treatment of Adults With Autism

NCT01630811 | Completed Phase 2 Results DMC

• 1 other identifier: CHKI-Nued0911
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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).

Conditions

Autism

Keywords

Adults

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline and 8 weeks

• Primary Safety Endpoints

  Number of serious adverse events

  Week 0 through week 25

Secondary Outcomes (1)

• Change in Aggressive Behavior

  Baseline and 8 weeks

Study Arms (2)

Nuedexta

EXPERIMENTAL

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

Drug: Nuedexta

Placebo

PLACEBO COMPARATOR

Oral, once daily

Other: Placebo

Interventions

Nuedexta DRUG

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.

Also known as: Dextromethorphan hydrobromide and quinidine sulfate

Nuedexta

Placebo OTHER

Placebo will be given once daily for 7 days.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sutter Health: lead

Study Sites (1)

Sutter Pediatric Neurology

Sacramento, California, 95816, United States

Location

Related Links

• Sutter Health Research

MeSH Terms

Conditions

Autistic Disorder

Interventions

dextromethorphan - quinidine combination; Dextromethorphan; Quinidine

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Cinchona Alkaloids; Quinuclidines; Quinolines; Heterocyclic Compounds, 2-Ring

Results Point of Contact

• Title: Michael Chez, MD
• Organization: Sutter Medical Group, Neurology

ChezM@sutterhealth.org

(916) 454-6667

Study Officials

• Michael G Chez, MD

  Sutter Health

  PRINCIPAL INVESTIGATOR

• Carol A Parise, PhD

  Sutter Health

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 26, 2012
• First Posted: June 28, 2012
• Study Start: January 24, 2012
• Primary Completion: December 15, 2015
• Study Completion: December 15, 2015
• Last Updated: December 8, 2017
• Results First Posted: December 8, 2017

Record last verified: 2017-11

Locations

US (1)