Treatment Resistant Epilepsy and N-Acetyl Cysteine

Withdrawn before enrolling · Not applicable

Conditions studied: Autistic Disorder, Seizures, Irritability

In brief

This is a study to find out whether the dietary amino acid supplement, N-acetyl cysteine (NAC) is helpful in reducing the frequency of seizures in children with autism and comorbid epilepsy whose seizures are not responding well to usual medical treatment. The study is also looking to see if this supplement is helpful for immediate and ongoing treatment of symptoms of irritability. Additionally, this study will also look to see if certain substances in the blood that measure a specific type of stress on cells in the body can help tell us how NAC may be helping.

Key facts

Study ID

NCT02054949

Run by

Nationwide Children's Hospital

People needed

0

Starts

2013-04-01

Expected to finish

2015-01-01

Last updated by the study team

2015-10-09

Who can join

Age: 6 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children and adolescents/young adults ages 6-21, male or female, all races and ethnicities.
• Autism
• IQ less than 80
• 10 subjects with treatment resistant generalized epilepsy as defined by trials of 3 or more anticonvulsants with continued seizure frequency of at least 1 per week, need to use a helmet, or vagal nerve stimulator placement.
• Children with at least 1 grand mal/generalized seizure per week.

You may not qualify if…

• Inability to swallow capsules
• In females, pregnancy or sexual activity
• Daily acetaminophen, glucocorticoid, or nonsteroidal anti-inflammatory drugs, or daily NAC or high-dose antioxidant vitamin supplements within 30 days of baseline.
• History of acute or chronic liver, renal, endocrine, infectious, autoimmune, hematologic, metabolic, or other disorder in the judgement of the study physician.

Where it is running

• Nationwide Children's Hospital — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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