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Fenfluramine for Lennox-Gastaut Syndrome
Study Summary
This trial will study whether ZX008 is an effective add-on therapy for people with Lennox-Gastaut syndrome who are experiencing uncontrolled seizures.
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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- My seizures happen in clusters and can't be counted individually.I have a history of heart or stroke issues.I am a male or a female not pregnant or breastfeeding, aged 2-35.My seizures are caused by a degenerative brain disease.I am not taking any medication that affects my mood or appetite significantly.I haven't had a serious illness or symptoms in the last month that could affect my study participation.My seizures cause me to fall and are not fully controlled by my current epilepsy medications.My seizures started when I was 11 or younger.I am currently taking 1 to 4 epilepsy medications.I have high blood pressure in the arteries of my lungs.I have been on felbamate for less than a year, or my liver tests are not stable, or my dose has changed in the last 60 days.
- Group 1: Open-Label
- Group 2: ZX008 0.2 or 0.8 mg/kg/day
- Group 3: Matching 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
Could you tell me if the age limit for this trial has been set at 65 years old?
"The age limit for this study is 35 years old. All patients that are over 2 years of age are eligible for enrolment."
Is this research being done for the first time?
"ZX008 0.2 or 0.8 mg/kg/day is being trialed in 6 active clinical studies spread across 15 countries and 56 cities. The first trial of this medication was completed in 2016 by Zogenix International Limited, Inc. This Phase 3 drug approval study had 373 participants. In the 5 years since 2016, 84 similar studies have been completed."
Which does the FDA recommend, a lower or higher dose of ZX008?
"ZX008 0.2 or 0.8 mg/kg/day is being trialed in Phase 3, meaning that while there is already some data supporting efficacy, multiple rounds of data are still needed to support safety. Our team rates it as a 3."
Could I take part in this research if I qualify?
"In order to qualify for this lennox gastaut syndrome study, potential participants must be between the ages of 2 and 35. As of right now, the trial is looking to enroll 296 individuals."
Are there other research papers which analyze the dosage of ZX008 0.2 or 0.8 mg/kg/day?
"ZX008 0.2 or 0.8 mg/kg/day was first studied in 2016 at The Children's Hospital Colorado. So far, there have been 84 completed studies with 6 more underway. Many of these studies are being conducted in Manchester, Pennsylvania."
Are there any patients who have yet to enroll in this research study?
"This particular clinical trial, as indicated by the website clinicaltrials.gov, is not currently looking for new patients to enroll. Although, there are 1440 other studies that are still recruiting patients. This study was originally posted on 27th November 2017 and was edited on 13th October 2020."
In how many different medical sites is this research project being offered?
"There are 32 clinical trial sites operating for this study, located in Manchester, Cleveland, Portland, and other cities."
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