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Expanded Access Use of Stiripentol in Dravet Syndrome or Sodium Channel Mutation Epileptic Encephalopathies

NCT02239276 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2020-02-05

No results posted yet for this study

Summary

This is an expanded access use of Stiripentol in Dravet Syndrome or epileptic encephalopathies associated with sodium channel mutations who have failed other drugs in an effort to give them the best chance at seizure control and quality of life. As a treatment protocol and not a research study, children will only be monitored on a clinical basis for seizure improvement and side effects predominantly by parent and caregiver report.

Conditions

  • Dravet Syndrome
  • Epileptic Encephalopathies Associated With SCN1A Mutations

Interventions

DRUG

Stiripentol

The initial dose of Stiripentol will be determined by the prescribing neurologist and titrated up to an initial goal dose of 50 mg/kg/day divided into 2 to 3 doses per day. Further dose increases by 10-20 mg/kg/day increments up to a max of 100 mg/kg/day or 4000 mg total daily dose may be necessary for improved seizure control.

Sponsors & Collaborators

  • Cook Children's Health Care System

    lead OTHER

Principal Investigators

  • Scott Perry, MD · Cook Children's Health Care System

Eligibility

Min Age
6 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02239276 on ClinicalTrials.gov