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Study Summary
This trial is testing a new drug to see if it is effective and safe in treating seizures in people with a certain type of epilepsy.
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.Trial Design
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Who is running the clinical trial?
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- I have symptoms similar to Dravet syndrome.I am currently taking 1 to 4 medications for seizures.I have at least one noticeable seizure every week and haven't been seizure-free for more than 20 days in a row.I am between 2 and 21 years old.I have had a serious head injury or disease affecting my brain.My caregiver can identify and record different types of my seizures.I am using medical marijuana or cannabinoids, not including Epidiolex/Epidyolex, unless approved.I am currently on steroids, not including asthma or allergy treatments.I weigh at least 10 kg.I do not have any health conditions that would interfere with the study.Your blood test results show values that could be risky for your health.Your ECG shows a QT interval longer than 450 milliseconds or any important heart problems.I have been diagnosed with SCN8A-DEE based on symptoms and genetic tests.I still have seizures after trying at least 2 seizure medications.
- Group 1: Placebo
- Group 2: NBI-921352
- 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
How many people are allowed to sign up for this experiment?
"That is correct. The information available on clinicaltrials.gov states that this trial began recruitment on 1/31/2022 and is still looking for patients as of 6/27/2022. So far, 52 people have been admitted at 11 different locations."
Are people of all ages welcome to participate in this research?
"Children aged 2 to 21 qualify for this particular trial. Out of the 532 clinical trials that exist for people under 18, this is one. 1258 trials target patients over 65 years old."
What is the regulatory status of NBI-921352?
"NBI-921352 is currently in Phase 2 of clinical trials, meaning that there is some evidence supporting its safety but none yet for efficacy. Our team at Power has given it a score of 2 out of 3."
Are there any patients needed for this research project?
"Currently, this clinical trial is recruiting patients that fit the specified criteria. The listing was first posted on January 31st, 2022 and has been updated as recently as June 27th, 2022."
Which patients fit the bill for this clinical trial?
"In order to qualify for this experiment, volunteers must experience aura and be between 2-21 years old. Up to 52 individuals will be accepted."
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