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Fenfluramine for Dravet and Lennox-Gastaut Syndromes
Study Summary
This trial is testing a new drug for safety in people with Dravet syndrome, Lennox-Gastaut syndrome or epileptic encephalopathy.
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?
Media Library
- You have a rare seizure disorder like epileptic encephalopathy and have finished another Zogenix-sponsored trial with ZX008.I am a man or a woman not pregnant or breastfeeding.I have a serious heart valve problem or high blood pressure in my lungs.I haven't taken any depression or migraine medications in the last 14 days.My liver is not working well.
- Group 1: ZX008 (Fenfluramine Hydrochloride)
- 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
How many people are given the opportunity to participate in this clinical trial?
"This particular trial is no longer looking for participants, however there are 1805 other studies and 6 trials respectively that might be of interest. These related clinical trials were most recently edited on June 28th, 2022."
When might the FDA approve ZX008 (Fenfluramine Hydrochloride)?
"There is some evidence for ZX008's efficacy and it has undergone multiple rounds of safety testing, so it receives a score of 3."
Where is this research being conducted?
"This trial is currently being conducted out of several locations including Vancouver, Atlanta and Montreal."
Are there any other cases in which ZX008 (Fenfluramine Hydrochloride) has been used for research?
"ZX008 (Fenfluramine Hydrochloride) was first researched in 2016 at The Children's Hospital Colorado. So far, there have been 5 completed studies with 6 more currently underway; a few of these active trials are based in Vancouver, British Columbia."
What are the researchers hoping to learn from this clinical trial?
"This trial, which will be evaluated over a period of up to 36 months, is looking at changes in laboratory test results as its primary outcome. Secondary outcomes include change in behavioral CGI by investigator (defined as the rating by investigator of the patient's change in behavioral symptoms since the beginning of study, on a scale from "very much improved" to "very much worse"), change in clinical global impression by investigator (defined as the rating by investigator of the patient's overall change in symptoms since the beginning of study, on a scale from "very much improved" to "very much worse"), and change in clinical global impression by parent/"
Are there any available spots for new recruits in this research?
"According to the listing on clinicaltrials.gov, this study is not recruiting new patients at this time. The trial was first posted on April 22nd, 2019 and was last updated on June 28th, 2022. Although this specific trial is not taking any more participants, there are 1,811 other trials that are actively looking for candidates."
Is this research unique in any way?
"ZX008 (Fenfluramine Hydrochloride) has been under clinical observation since 2016. The original study was funded by Zogenix International Limited, Inc., which is a child company of Zogenix, Inc.. In total, 373 were observed in the first Phase 3 drug approval trial in 2016. Currently, there are 6 active studies being conducted for ZX008 (Fenfluramine Hydrochloride), spanning 56 cities and 15 countries."
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