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ZX008 (Fenfluramine Hydrochloride) for Dravet Syndrome
Study Summary
This trial will observe the long-term safety of ZX008 in people with Dravet syndrome.
- Dravet Syndrome
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 3 trial • 262 Patients • NCT02682927Trial Design
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Who is running the clinical trial?
Frequently Asked Questions
What is the sample size for this experiment?
"This clinical trial is not enrolling patients at the moment. It was originally posted on July 5th, 2016 and last updated November 8th, 2022. If you are looking for other trials, there are currently 1452 trials actively enrolling patients with epilepsies and 6 trials for ZX008 (Fenfluramine Hydrochloride) that need participants."
Who does this trial hope to enroll as participants?
"Eligible patients for this trial must have a diagnosis of epilepsy, myoclonic subtype and be between 2-35 years old. Currently, the study is looking to recruit a total of 373 individuals."
Does this study have an age limit?
"Based on the age parameters set out in this study's eligibility requirements, the lower bound for participants is 2 years old while the upper limit is 35."
Are we still able to enroll new participants in this experiment?
"From what is detailed on clinicaltrials.gov, this particular trial is not looking for new patients as of now. This trial was initially posted on July 5th 2016 and has had its most recent update on November 8th 2022. Even though this study isn't searching for participants, there are 1,458 other trials that currently are."
What kind of side effects does ZX008 (Fenfluramine Hydrochloride) have?
"ZX008 (Fenfluramine Hydrochloride) has received a score of 3 from our analysts at Power. This is because it is a Phase 3 trial, which means that there is both evidence supporting its efficacy and multiple rounds of data collected on its safety."
How many different places are testing this out?
"Children's Hospital of Philadelphia (Philadelphia, Pennsylvania), Seattle Children's Hospital (Seattle, Washington), Neurology and Epilepsy Research Center (Orlando, Florida) are the 4 primary sites for this trial. Additionally, there are 26 other hospitals participating in this clinical study."
Are there any other notable cases of ZX008 (Fenfluramine Hydrochloride) being tested in a medical setting?
"ZX008 (Fenfluramine Hydrochloride) was first evaluated in 2016 at The Children's Hospital Colorado. Out of the 5 completed clinical trials, 6 are presently active- many of which are based in Philadelphia, Pennsylvania."
Does this research break new ground in the medical field?
"ZX008 (Fenfluramine Hydrochloride) has been researched since 2016 by Zogenix International Limited, Inc.. The first Phase 3 clinical trial occurred in 373 patients across 56 cities and 15 countries."
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