Phase 2
N=13
Nuedexta for the Treatment of Adults With Autism
Autism
Bottom Line
View on ClinicalTrials.gov: NCT01630811 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Change in Maladaptive Behaviors — -6.62; -1.08 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nuedexta (Drug); Placebo (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sutter Health
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Maladaptive Behaviors |
-6.62; -1.08 | — |
| PRIMARY Primary Safety Endpoints |
0; 0 | — |
| SECONDARY Change in Aggressive Behavior |
-1.92; 0.08 | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT01630811). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.