Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
13 participants
INTERVENTIONAL
2012-01-24
2015-12-15
Brief Summary
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Secondary: Demonstrate a trend towards reduced aggressive behavior as measured by Overt Aggression Scale (OAS).
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Nuedexta
Nuedexta (Dextromethorphan hydrobromide 20 mg/quinidine sulfate 10 mg), oral, once daily
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.
Placebo
Oral, once daily
Placebo
Placebo will be given once daily for 7 days.
Interventions
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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.
Placebo
Placebo will be given once daily for 7 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
60 Years
ALL
No
Sponsors
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Sutter Health
OTHER
Responsible Party
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Michael Chez, MD
Principal Investigator
Principal Investigators
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Michael G Chez, MD
Role: PRINCIPAL_INVESTIGATOR
Sutter Health
Carol A Parise, PhD
Role: STUDY_DIRECTOR
Sutter Health
Locations
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Sutter Pediatric Neurology
Sacramento, California, United States
Countries
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Related Links
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Sutter Health Research
Other Identifiers
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CHKI-Nued0911
Identifier Type: -
Identifier Source: org_study_id