Nuedexta for the Treatment of Adults With Autism

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Sutter Health
Sponsor:
Information provided by (Responsible Party):
Michael Chez, MD, Sutter Health
ClinicalTrials.gov Identifier:
NCT01630811
First received: June 26, 2012
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Autism
Drug: Nuedexta
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Nuedexta for Neurobehavioral Symptoms of Adults With Autism Spectrum Disorder

Resource links provided by NLM:


Further study details as provided by Sutter Health:

Primary Outcome Measures:
  • Reduction in Maladaptive Behaviors [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Reduction in Aggressive Behavior [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]
    Demonstrate a trend towards reduced aggressive behavior as measured by Overt Aggression Scale (OAS).

  • Safety and Tolerability [ Time Frame: 44 weeks ] [ Designated as safety issue: Yes ]
    Safety and tolerability will be assessed through monitoring of cardiac, renal and liver function.


Estimated Enrollment: 20
Study Start Date: June 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nuedexta 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
Placebo Comparator: Placebo 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01630811

Contacts
Contact: Bobbie Benabides, BA (916) 454-6924 BenaBib@sutterhealth.org
Contact: Carol Parise, PhD (916) 733-4413 PariseC@sutterhealth.org

Locations
United States, California
Sutter Pediatric Neurology Recruiting
Sacramento, California, United States, 95816
Sponsors and Collaborators
Sutter Health
Investigators
Principal Investigator: Michael G Chez, MD Sutter Health
Study Director: Carol A Parise, PhD Sutter Health
  More Information

Additional Information:
No publications provided

Responsible Party: Michael Chez, MD, Principal Investigator, Sutter Health
ClinicalTrials.gov Identifier: NCT01630811     History of Changes
Other Study ID Numbers: CHKI-Nued0911
Study First Received: June 26, 2012
Last Updated: July 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Sutter Health:
Adults

Additional relevant MeSH terms:
Child Development Disorders, Pervasive
Autistic Disorder
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dextromethorphan
Quinidine
Quinidine gluconate
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antitussive Agents
Central Nervous System Agents
Therapeutic Uses
Respiratory System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on July 23, 2014