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Study About the Safety of Soticlestat and if it can Help Children and Adults With Dravet Syndrome or Lennox-Gastaut Syndrome who Have Already Taken Fenfluramine
EU CTIS ID: 2023-504104-29-00
What this study is testing
To assess the efficacy of soticlestat in participants with DS or LGS who have been exposed to fenfluramine.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- The participant, of any sex, and aged ≥2 years, at the time of informed consent.
- The participant has a documented clinical diagnosis of DS/LGS supported by variable combinations of typical clinical features and as determined by the investigator.
- The participant has been exposed to fenfluramine (currently on or used previously).
You likely can't join if
- The participant has an unstable, clinically significant disease or other abnormality that may impact the ability to participate in the study or that may potentially confound the study results.
- The participant is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property, or the participant has attempted suicide within 12 months before the screening visit (Visit 1).
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.