Nuedexta for the Treatment of Adults With Autism
This study is currently recruiting participants.
Verified July 2012 by Sutter Health
Sponsor:
Sutter Health
Information provided by (Responsible Party):
Michael Chez, MD, Sutter Health
ClinicalTrials.gov Identifier:
NCT01630811
First received: June 26, 2012
Last updated: July 9, 2012
Last verified: July 2012
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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:
MedlinePlus related topics:
Autism
Drug Information available for:
Quinidine sulfate
Dextromethorphan hydrobromide
Dextromethorphan
Quinidine gluconate
Nuedexta
U.S. FDA Resources
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: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Nuedexta |
Drug: Nuedexta
Neudexta (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
Neudexta (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 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 18 to 50 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 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
- Eligible for administration of ADOS module 2, 3 or 4 which indicates verbal fluency
- Stable on any current medication(s) for 2 months
- Refrain from medications that contain dextromethorphan
Exclusion Criteria:
- Clinically uncontrolled epilepsy
- Cardiac rhythm or structural malformation
- Known genetic disorders including fragile x, and other confounding factors (e.g., cerebral palsy, head injury, brain tumor)
- Known allergy to either dextromethorphan or quinidine
- Concurrent or recent use of Monoamine oxidase inhibitor (MAOI) antidepressants
- Current use of Nuedexta
- Cardiovascular conditions including heart failure, prolonged QT interval, congenital long QT syndrome, history of torsades de pointes, complete atrioventricular block (AV block) or at risk of AV block
- Thrombocytopenia, hepatitis, bone marrow depression or lupus-like syndrome
- Concurrent use of drugs that both prolong QT intervals and are metabolized by Cytochrome P450 2D6 (CYP2D6)
- Pregnancy - females of childbearing potential must be on a reliable form of contraception
- Concurrent use of lamotrigine or felbamate or other N-Methyl-D-aspartate (NMDA) agonists or antagonists
Contacts and Locations
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 9, 2012 |
| 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 June 18, 2013