Clinical trial NCT01630811: Nuedexta for the Treatment of Adults With Autism
Official title: Nuedexta for Neurobehavioral Symptoms of Adults With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Autism
Keywords: Adults
Lead sponsor: Sutter Health
Sponsor class: OTHER
First posted: 2012-06-28
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

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 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 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

Primary outcomes:
measure: Change in Maladaptive Behaviors
timeFrame: Baseline and 8 weeks
measure: Primary Safety Endpoints
timeFrame: Week 0 through week 25
Secondary outcomes:
measure: Change in Aggressive Behavior
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Sutter Pediatric Neurology
state: California
Study officials:
affiliation: Sutter Health
name: Michael G Chez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sutter Health
name: Carol A Parise, PhD
role: STUDY_DIRECTOR
References: