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Study Summary
This trial is testing a new drug to see if it can help reduce the number of seizures people with DS have.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
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 have been taking the same dose of artisanal CBD for at least 4 weeks.I have been diagnosed with Down syndrome.I weigh at least 10 kg.My seizures are not controlled despite trying at least one antiseizure medication.I am on up to 4 stable seizure medications, including possibly benzodiazepines, fenfluramine, or Epidiolex.I've had more than 12 seizures in the last 3 months and at least 4 seizures every month during the last 1 to 1.5 months.
- Group 1: Soticlestat
- Group 2: Placebo
- 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
Is this trial limited to a particular age group?
"According to the age requirements set out by the researchers conducting this clinical trial, the youngest a patient can be is 2 years old whereas the oldest a patient can be is 21 years old."
Has Soticlestat been cleared by the FDA?
"Soticlestat has received a safety score of 3. This assessment comes from a Phase 3 trial, where there is both some evidence of efficacy and multiple rounds of data supporting safety."
How many different sites are coordinating this trial?
"To limit travel as a burden, it is recommended to choose a clinical trial site that is close to your location from the 21 options. A few of the locations recruiting patients are Fort Worth, Gulf Breeze and Columbus."
Could you explain the requirements for volunteers for this experiment?
"This clinical trial is reserved for patients that suffer from epilepsies and myoclonic seizures. The ages of the patients should fall between 2 and 21. In total, 142 people can be admitted into the study."
Are new participants being accepted for this experiment currently?
"The study is ongoing and actively recruiting patients, as reflected in the clinicaltrials.gov listing which was last updated on 10/13/2022."
How many enrollees are allowed in this clinical trial?
"That is accurate. The clinical trial is currently ongoing, as per the information available on clinicaltrials.gov. The study began enrolling patients on 10/28/2021 and the most recent update was on 10/13/2022. A total of 142 patients are being recruited from 21 different locations."
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