BridgeMD
Open-label Follow-up Study of Soticlestat in Adults and Children with Developmental Epileptic Encephalopathies
EU CTIS ID: 2022-502801-13-00
What this study is testing
Assess the long-term safety and tolerability of soticlestat when administered as adjunctive therapy to at least one anti-seizure therapy (ie, antiepileptic drugs [AEDs], vagal nerve stimulator, ketogenic diet or modified Atkins diet) in subjects with rare epilepsies.
- Therapeutic exploratory (Phase II)
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
- 1. Subjects must have participated in a previous soticlestat study and meet one of the following conditions: -Successfully completed a Soticlestat clinical study. -Received at least 10 weeks of treatment (combined Dose Optimization and Maintenance Period) with the study drug in an antecedent placebo controlled blinded soticlestat clinical study and the subject did not have a serious or severe AE that, in the investigator's or sponsor's opinion, was related to the study drug and would make it unsafe for the subject to continue receiving the study drug. - In the opinion of the investigator, the subject has the potential to benefit from the administration of soticlestat (not applicable for Spain).
You likely can't join if
- 1. Clinically significant disease, that, in the investigator's opinion, precludes study participation. 2. Suicide attempt within the last year, at significant risk of suicide (either in the opinion of the investigator or defined as 'yes' to suicidal ideation question 4 or 5 on the C-SSRS at Screening) or appearing suicidal per investigator judgment.
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- Israel
- China
- United States
- Canada
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, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; Israel; China; United States; Canada. 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.