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Fenfluramine for Lennox-Gastaut Syndrome

Phase 3
Waitlist Available
Research Sponsored by Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or non-pregnant, non-lactating female, age 2 to 35 years, inclusive as of the day of the Screening Visit
Clinical diagnosis of Lennox-Gastaut syndrome, where seizures that result in drops are not completely controlled by current antiepileptic treatments
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months open label
Awards & highlights

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.

Who is the study for?
This trial is for children and adults aged 2 to 35 with Lennox-Gastaut syndrome, a type of epilepsy. Participants must have seizures not fully controlled by current medications, abnormal cognitive development, and be on 1-4 anti-epileptic drugs. They can't join if they have certain medical conditions like pulmonary arterial hypertension or cardiovascular disease, are taking specific conflicting medications, or only experience clustered drop seizures.Check my eligibility
What is being tested?
The study tests ZX008 (Fenfluramine Hydrochloride) as an additional treatment for uncontrolled seizures in Lennox-Gastaut syndrome patients. It's a double-blind test comparing two doses of ZX008 against a placebo to see which is more effective at reducing seizure frequency.See study design
What are the potential side effects?
Potential side effects of ZX008 may include risks related to heart valve issues and pulmonary arterial hypertension due to its similarity with fenfluramine. Other common drug-related side effects could involve changes in appetite or mood, drowsiness, and gastrointestinal symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a male or a female not pregnant or breastfeeding, aged 2-35.
Select...
My seizures cause me to fall and are not fully controlled by my current epilepsy medications.
Select...
My seizures started when I was 11 or younger.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months open label
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months open label for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1: Change from baseline in frequency of seizures that result in drops in subjects receiving ZX008 compared to placebo
Secondary outcome measures
Part 2: Adverse events and related safety parameters in subjects receiving ZX008 compared to placebo

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: ZX008 0.2 or 0.8 mg/kg/dayExperimental Treatment1 Intervention
Part 1: ZX008 is supplied as an oral solution. Subjects will be randomized to receive 1 of 2 doses of ZX008 0.2 mg/kg/day or 0.8 mg/kg/day.
Group II: Open-LabelExperimental Treatment1 Intervention
Part 2: ZX008 is supplied as an oral solution. Study medication will be administered twice a day (BID) in equally divided doses.
Group III: Matching PlaceboPlacebo Group1 Intervention
Part 1: Matching ZX008 placebo is supplied as an oral solution.

Find a Location

Who is running the clinical trial?

Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.Lead Sponsor
11 Previous Clinical Trials
1,449 Total Patients Enrolled
2 Trials studying Lennox Gastaut Syndrome
421 Patients Enrolled for Lennox Gastaut Syndrome
UCB CaresStudy Director001 844 599 2273
203 Previous Clinical Trials
44,066 Total Patients Enrolled
1 Trials studying Lennox Gastaut Syndrome
412 Patients Enrolled for Lennox Gastaut Syndrome

Media Library

ZX008 0.2 or 0.8 mg/kg/day Clinical Trial Eligibility Overview. Trial Name: NCT03355209 — Phase 3
Lennox Gastaut Syndrome Research Study Groups: Open-Label, ZX008 0.2 or 0.8 mg/kg/day, Matching Placebo
Lennox Gastaut Syndrome Clinical Trial 2023: ZX008 0.2 or 0.8 mg/kg/day Highlights & Side Effects. Trial Name: NCT03355209 — Phase 3
ZX008 0.2 or 0.8 mg/kg/day 2023 Treatment Timeline for Medical Study. Trial Name: NCT03355209 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~11 spots leftby Jul 2024