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Anti-epileptic drug
Valproate for Aggression in Autism
Phase 3
Waitlist Available
Led By Jessica A. Hellings, M.D.
Research Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will study whether valproate can help reduce aggression in children and adolescents with autism.
Who is the study for?
This trial is for children and adolescents with autism who live in the Kansas City area and display aggressive behavior. Participants must not have a history of liver disease, sensitivity to valproate, seizures recently, unstable illnesses, ovarian cysts or be on psychoactive maintenance medications.Check my eligibility
What is being tested?
The study is testing whether valproate can help manage aggression in autistic youths. Valproate is traditionally used for seizures and bipolar disorder but its effects on autism-related aggression are being explored here.See study design
What are the potential side effects?
Valproate may cause side effects like nausea, fatigue, hair loss, weight changes or mood swings. It might also affect liver function or blood cell counts which will be monitored closely during the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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Who is running the clinical trial?
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,737 Total Patients Enrolled
82 Trials studying Autism Spectrum Disorder
40,352 Patients Enrolled for Autism Spectrum Disorder
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Lead Sponsor
1,965 Previous Clinical Trials
2,672,767 Total Patients Enrolled
35 Trials studying Autism Spectrum Disorder
9,724 Patients Enrolled for Autism Spectrum Disorder
Jessica A. Hellings, M.D.Principal InvestigatorUniversity of Kansas
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had seizures in the last 6 months.I have had a bad reaction to valproate or liver disease in the past.I am on stable medication for my mental health.I have a degenerative brain disorder.I have had ovarian cysts in the past.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How can I become a participant in this research project?
"Eligible candidates for this autism study must be between 6-21 years old. So far, 30 people have been enrolled in the trial."
Answered by AI
What are the possible risks associated with this treatment?
"This is a Phase 3 trial, which means that while there is data supporting efficacy, there have been multiple rounds of testing affirming the safety of this treatment. Our team rates it as a 3 on our 1-to-3 scale."
Answered by AI
Does this research include elderly participants?
"The age range that this trial is recruiting for starts at 6 years old and goes up to 21 years of age."
Answered by AI
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