A Clinical Trial for Dravet Syndrome (DS) in Kids
Summary
This study is for children 2 to 17 years old with a clinical diagnosis of Dravet Syndrome (DS) to take part in a 25-week clinical research study. The primary purpose of this clinical research study is to evaluate the safety and effectiveness of an investigational medication(Soticlestat as add on therapy) for Dravet Syndrome (DS).
Individuals will be evaluated to determine their eligibility to participate in this study. Each patient who qualifies will receive either the investigational medication or a placebo, 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
Eligible gender: Male, Female
Eligible ages: 2 to 17
Inclusion criteria:
Your or your child may be eligible to participate in this trial if you or your child:
- age between 2 and 17 years
- have been diagnosed with Dravet Syndrome (DS)
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:
- Received the drug Soticlestat previously
- Is currently pregnant, or breast feeding
- Currently enrolled in a clinical study
- Any history of alcohol, opioid, or other drug use disorder.
- Known hypersensitivity to any component of the soticlestat
Participate
Fill out the following form if you want to participate in this research
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 Paola Meza Santoscoy at Paola.MezaSantoscoy@albertahealthservices.ca or 403-955-5722
Principal investigator:
Julia Jacobs-Levan
Clinical trial:
Yes
REB-ID:
REB22-0892