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

Summary

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.

Eligibility

Currently recruiting participants: Yes

Eligible ages: 0 to 18

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 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.

Participate

Fill out the following form if you want to participate in this research

Method of contact

Collection of personal information
Your personal information is collected under the authority of section 33(c) of the Freedom of Information and Protection of Privacy Act. If you have any questions about the collection or use of this information, please visit our Access to Information page.

Additional information

Contact information

Please contact Dr. Julia Jacobs-LeVan at 4039552480 or Julia.Jacobs-LeVan@albertahealthservices.ca or study coordinator Ransi Nayakarathna at ransi.nayakarathna@albertahealthservices.ca or (403) 9552747 if you would like to learn more about this trial.

Principal investigator:

Julia Jacobs-Levan

Clinical trial:

Yes

REB-ID:

REB24-0346