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A Multicenter, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effect on Seizures and Behavioral Symptoms of Radiprodil in Patients with Tuberous Sclerosis Complex (TSC) or Focal Cortical Dysplasia (FCD) Type II

Epilepsy | Seizures | Tuberous Sclerosis

This study is for children aged ≥ 6 months up to 18 years old patients with Tuberous Sclerosis Complex (TSC) or Focal Cortical Dysplasia (FCD) Type II to take part in a 24-week long clinical research study. The primary purpose of this study is to learn more about the safety and effectiveness of an investigational medication for TSC and FCD.
Individuals will be evaluated to determine their eligibility to participate in this study. Each patient who qualifies will receive the investigational medication, as well as study-related medical exams and study-related laboratory tests, at no cost. Compensation for time and travel may also be available.

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Participation Requirements

  • Sex:

    Male, Female, Intersex

  • Eligible Ages:

    0 to 18

Participation Criteria

Inclusion Criteria:
You or your child may be eligible to participate in this trial if you or your child:
- aged ≥ 6 months up to 18 years old
- have been diagnosed with FCD type II or TSC
- have countable motor seizures which at least 2 anti-seizure medicine have failed to control
Doctors will also evaluate other criteria to make sure you or your child qualify for the study.
Exclusion Criteria:
You or your child may not be eligible to participate in this trial if you or your child:
- have hypersensitivity to the study drug
- have severe liver dysfunction
Doctors will also evaluate other criteria to make sure you or your child qualify for the study.

Study Location

University of Calgary
University of Calgary
Calgary, Alberta
Canada

Contact Study Team

Study Sponsored By
University of Calgary
Participants Required
More Information
Study ID: REB24-0346