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Study Summary
This trial is testing if a new drug, soticlestat, can help reduce seizures in children and adults with Dravet Syndrome or Lennox-Gastaut Syndrome.
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Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 2 trial • 20 Patients • NCT03694275Trial Design
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Who is running the clinical trial?
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- I am not at risk of harming myself or others.
- Group 1: Soticlestat
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What are the potential harmful effects of Soticlestat?
"Soticlestat has undergone multiple rounds of testing and there is some efficacy data, so it received a score of 3."
How many people are being given the chance to participate in this research?
"That is correct, the clinical trial is currently underway with a goal of 376 patients from 22 different centres. The data on clinicaltrials.gov show that the study was first posted on March 4th, 2022 and edited April 4th, 2022."
What are the goals of this clinical trial?
"The purpose of this long-term study is to assess the changes in body weight for children aged 10-17 years old. Additionally, CGI-I Seizure Intensity and Duration Score, Clinical Global Impression of Improvement (CGI-I) Score, and Caregiver Global Impression of Improvement (Care GI-I) Score will be used as secondary measures over the course of 4 years."
Does this research project have an age limit for participants?
"Adults aged 2 to 36 years old can enroll in this trial. There are a total of 389 studies for people under 18 and 1034 for patients 65 and older."
Is this test phase of the research still recruiting more participants?
"Yes, this study is still open and looking for participants. The listing on clinicaltrials.gov shows that the posting was created on March 4th, 2022 and last updated April 4th of the same year."
Who does this clinical trial hope to enroll?
"As indicated by the parameters set out on this clinical trial, individuals with lennox gastaut syndrome (LGS) between the ages of 2 and 36 may be eligible to participate. Up to 376 patients are needed for the study."
Where can I find a medical facility that is running this trial?
"In addition to other locations, this trial is accepting patients at Midatlantic Epilepsy and Sleep Center in Bethesda, Maryland, Oregon Health and Science University in Portland, Oregon, and David Geffen School of Medicine at UCLA in Los Angeles, California."
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