- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00467753
Oxcarbazepine Versus Placebo in Childhood Autism
January 7, 2021 updated by: Sherie Novotny, M.D., University of Medicine and Dentistry of New Jersey
The proposed study is designed to assess the effectiveness of treatment with Oxcarbazepine vs. placebo in childhood/adolescent autism.
This is a twelve-week study involving twenty subjects between the ages of five and seventeen with a diagnosis of autism.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The proposed study is designed to assess the effectiveness of treatment with Oxcarbazepine vs. placebo in childhood/adolescent autism.
This is a twelve-week study involving twenty subjects between the ages of five and seventeen with a diagnosis of autism.
Subjects will receive a psychiatric and medical evaluation by the study psychiatrist to see if she/he has any psychiatric or medical illnesses that would interfere with their ability to participate in this study.
These evaluations may take up to an hour to complete.
In addition, subjects will be asked to participate in a psychiatric interview designed to determine the child's diagnosis and current problem areas.
The subject's parent will also be asked to fill out psychiatric questionnaires.
The interview and questionnaires may take up to 4 hours to complete.
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Jersey
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Piscataway, New Jersey, United States, 08854
- Child and Adolescent Psychiatry at the University Behavioral Healthcare Building, UMDNJ-RWJMS
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 15 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subject has autism.
- Subject is between five and seventeen years of age
- Subject is not hospitalized.
Exclusion Criteria:
- Subject has been diagnosed with a psychopathic disorder or a mood disorder, including depression or bipolar disorder.
- Subject has displayed self-injurious behavior.
- Subject has an active seizure disorder or epilepsy.
- Subject has an unstable medical illness.
- Subject has undergone brain injury.
- Subject has a history of diabetes.
- Subject has a history of prior treatment with oxcarbazepine of 600 mg/day for 6 weeks.
- Subject has used other study drugs within the previous 30 days.
- Subject is a pregnant female or unwilling to use acceptable contraception if sexually active.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Oxcarbazepine
Oxcarbazepine is the active drug to be given to subjects in the experimental arm
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Oxcarbazepine is available in a 300mg/5ml solution.
Dosage will start at 150 mg (2.5ml) at night for 3 days and will be increased to 150 mg in the am and pm.
For children who are able to tolerate the 150 mg BID dose, the oxcarbazepine will be increased to 300 mg at night and 150 mg in the morning for 3 days and 300 mg BID for the next week.
The children will remain on this dose until week 3, at which time if they are tolerating the medication and do not have a Clinical Global Improvement Scale (CGI) of 1 (very much improved) they will be increased to 600 mg twice a day in a method similar to the above increases.
After week 4, the child will remain on the same stable dose.
Other Names:
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Placebo Comparator: Sugar Pill
Patients are given either active or inactive intervention.
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Dosage similar to active drug
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vineland Adaptive Behavior Scales
Time Frame: Evaluated during Baseline and Termination
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The Vineland Scale is a semi-structured informant interview that assesses subjects' functioning.
It is administered to a caretaker/family member.
The scale has been revised and standardized in all populations.
This scale has been found to assess social deficits in autism and strengths in daily living skills.
Items are classified under four major adaptive domains: communication, daily living skills, socialization and motor skills.
The items are scored 0-2 (yes/sometimes/never).
Each domain is summed, and the domain scores are converted to standardized scores.
The normative score is 100, with standard deviation of 15.
The standardized score is used in this study.
A higher score (above 100) means better adaptive behavior.
Minimum value is 0, maximum value is infinity.
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Evaluated during Baseline and Termination
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Aberrant Behavior Checklist
Time Frame: Bi weekly
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Aberrant Behavior Checklist (ABC)-Community Version (Irritability Subscale) (Aman et al. 1985).
It is designed to objectively identify five behavior subscales through observation by the primary caregiver.
The five behavior subscales include (ranges show no problem to severe problem): irritability (range 0-45), lethargy (range 0-48), stereotypy (range 0-21), hyperactivity range 0-48), and inappropriate speech (range 0-12), all possible signs and symptoms of affective instability in autistic individuals (Lainhart & Folstein, 1994).
Improvement is shown with scores decreasing over time.
Total score is not used.
Inter-rater reliability for the ABC-CV is moderate to high across subscales with a mean of .63.
Test-retest reliability correlations are .98
-Irritability, .99
-Lethargy, .98 -Stereotypy, .98 -Hyperactivity, and .96
-Inappropriate Speech.
The ABC will be filled out by an informant (teacher/parent), and then reviewed by the IE.
Administration time is approximately 10 minutes.
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Bi weekly
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Autism Diagnostic Observation Schedule
Time Frame: Evaluated during Baseline and Termination
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The Autism Diagnostic Observation Schedule is primarily used as a diagnostic tool providing a standardized assessment for observation of social and communicative behavior in children and adults.
It is composed of four modules for assessing children/adults of varying language ability (Module 1 for nonverbal individuals, to Module 4 fluent individuals).
The instrument provides a series of structured and semi-structured presses for social interaction and communication, which are then scored.
The scores are 0 (no behavior) to 3 (markedly abnormal).
Subcategories are Language/communication, 8 scores, Social interaction, 12 scores, Stereotyped Behavior/restricted interests, 4 scores and Play, 2 scores, as well as other behavior, 3 scores.
The maximum score is 87, minimum is 0, with cutoff scores to determine diagnosis.
Higher scores indicate a more severe behavioral disorder.
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Evaluated during Baseline and Termination
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Clinical Global Impression Improvement (CGI-AD)
Time Frame: Administered weekly Administered weekly
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Clinical Global Impression Improvement (CGI)-AD (Guy, 1976).
This is a standard rating scale with 7-point global severity and change scales which has been modified for Autistic Disorder.
A rating of 2 is given when there is a substantial reduction in symptoms so that a treating clinician would be unlikely to change treatment.
A rating of 1 is reserved for patients who become virtually symptom-free.
A rating of 3 (minimally improved) on the CGI is defined as slight symptomatic improvement that is not deemed clinically significant.
Administration time is approximately 2 minutes.
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Administered weekly Administered weekly
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sherie L. Novotny, M.D, University of Medicine and Dentistry of New Jersey
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2006
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
April 27, 2007
First Submitted That Met QC Criteria
April 30, 2007
First Posted (Estimate)
May 1, 2007
Study Record Updates
Last Update Posted (Actual)
January 13, 2021
Last Update Submitted That Met QC Criteria
January 7, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Neurodevelopmental Disorders
- Child Development Disorders, Pervasive
- Autism Spectrum Disorder
- Autistic Disorder
- Molecular Mechanisms of Pharmacological Action
- Membrane Transport Modulators
- Anticonvulsants
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Oxcarbazepine
Other Study ID Numbers
- 0220055339
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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