Treatment Resistant Epilepsy and N-Acetyl Cysteine

NCT02054949 | Withdrawn DMC

• 1 other identifier: IRB12-00325
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autistic Disorder; Seizures; Irritability

Keywords

N-acetyl cysteine; Refractory Seizures

Outcome Measures

Primary Outcomes (1)

• Recruitment rate

  screening to enrollment and retention rates will be measured

  1 year

Secondary Outcomes (1)

• seizure frequency

  up to 8 weeks

Other Outcomes (4)

• side effect rating form for children and adolescents

  at baseline, 4, and 8 weeks

• Aberrant Behavior Checklist

  baseline, 4, and 8 weeks

• Autism Spectrum Rating Scale

  baseline, 4, and 8 weeks

Study Arms (1)

N-Acetyl Cysteine (NAC)

EXPERIMENTAL

NAC will be started at 500 mg by mouth twice daily for the first 2 weeks, then increased to 500 mg in the am and 1000 mg in the pm for week 3, and then increased to 1000 mg am and pm for weeks 4 through 8. Subjects will be maintained at the highest tolerated dose.

Drug: N-Acetyl Cysteine (NAC)

Interventions

N-Acetyl Cysteine (NAC) DRUG

NAC will be started at 500 mg by mouth twice daily for the first 2 weeks, then increased to 500 mg in the am and 1000 mg in the pm for week 3, and then increased to 1000 mg am and pm for weeks 4 through 8. Subjects will be maintained at the highest tolerated dose.

N-Acetyl Cysteine (NAC)

Eligibility Criteria

• Age: 6 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children and adolescents/young adults ages 6-21, male or female, all races and ethnicities.
• Autism
• IQ less than 80
• 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.

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Autistic Disorder; Seizures

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Barbara Gracious, MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 3, 2014
• First Posted: February 4, 2014
• Study Start: April 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: October 9, 2015

Record last verified: 2015-10

Locations

US (1)