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EpiCom : A Treatment Study of Tuberous Sclerosis Complex in Participants aged 2 to 18 years old

Tuberous Sclerosis

This study is for children age between 2 and 18 years who have tuberous sclerosis complex to take part in a 62 weeks long clinical research study. The primary purpose of this clinical
research study is to learn more about behavioral challenges and other non-seizure symptoms in patients with tuberous sclerosis complex who start EPID(I/Y)OLEX (an investigational study medicine) as add-on therapy for their seizures. 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

  • Eligible Ages:

    2 to 18

Participation Criteria

Inclusion Criteria:
You or your child may be eligible to participate in this trial if you or your child

- 2 to 18 years of age
- Has a confirmed clinical diagnosis of Tuberous sclerosis complex with a history of seizures.

Doctors will also evaluate other criteria to make sure you and 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:
- Is currently pregnant, or breast feeding.
- Has a clinically significant unstable medical condition
- Currently enrolled in a clinical 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: REB23-1683