CompletedNot Applicable

Oxcarbazepine Versus Placebo in Childhood Autism

United States5 participantsStarted 2006-04

Plain-language summary

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.

Who can participate

Age range

5 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Vineland Adaptive Behavior Scales

Timeframe: Evaluated during Baseline and Termination

Aberrant Behavior Checklist

Timeframe: Bi weekly

Autism Diagnostic Observation Schedule

Timeframe: Evaluated during Baseline and Termination

Clinical Global Impression Improvement (CGI-AD)

Timeframe: Administered weekly Administered weekly

Trial details

NCT IDNCT00467753

SponsorUniversity of Medicine and Dentistry of New Jersey

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-12

Results submitted2013-10-25

View on ClinicalTrials.gov More Autism trials

Who can participate

Age range

5 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Vineland Adaptive Behavior Scales

Timeframe: Evaluated during Baseline and Termination

Aberrant Behavior Checklist

Timeframe: Bi weekly

Autism Diagnostic Observation Schedule

Timeframe: Evaluated during Baseline and Termination

Clinical Global Impression Improvement (CGI-AD)

Timeframe: Administered weekly Administered weekly