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Serotonin Receptor Agonist

Fenfluramine for Dravet and Lennox-Gastaut Syndromes

Phase 3
Waitlist Available
Research Sponsored by Zogenix, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or nonpregnant, nonlactating female
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months open-label
Awards & highlights

Study Summary

This trial is testing a new drug for safety in people with Dravet syndrome, Lennox-Gastaut syndrome or epileptic encephalopathy.

Who is the study for?
This trial is for children and adults with rare seizure disorders like Dravet syndrome or Lennox-Gastaut syndrome, who have completed a prior Zogenix study. Participants must not be pregnant, breastfeeding, have serious liver issues, heart valve problems or pulmonary hypertension, nor take certain medications affecting serotonin within 14 days of the trial.Check my eligibility
What is being tested?
The study tests the long-term safety of ZX008 (Fenfluramine Hydrochloride) oral solution in patients with specific epileptic encephalopathies. It's an international study where all participants receive the drug to see how it affects them over time.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include those related to fenfluramine's known risks such as heart-related issues, changes in mood or behavior, digestive disturbances and possible impacts on growth and weight.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a man or a woman not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months open-label
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 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
Change in Adverse Events and Serious Adverse Events leading to study withdrawal in subjects receiving open label ZX008
Change in body weight
Changes in blood pressure
+5 more
Secondary outcome measures
Change in Behavioral CGI by Investigator
Change in Behavioral CGI by Parent/Caregiver
Change in Clinical Global Impression by Investigator
+6 more

Side effects data

From 2020 Phase 3 trial • 262 Patients • NCT02682927
38%
Decreased appetite
21%
Somnolence
19%
Pyrexia
17%
Blood glucose decreased
17%
Echocardiogram abnormal
15%
Diarrhoea
13%
Tremor
10%
Fatigue
8%
Upper respiratory tract infection
8%
Platelet count decreased
8%
Weight decreased
8%
Rash
6%
Cough
6%
Vomiting
6%
Lethargy
6%
Asthenia
6%
Hypoglycaemia
4%
Drooling
4%
Viral infection
4%
Rhinitis
4%
Blood pressure increased
4%
Ataxia
4%
Balance disorder
4%
Abnormal behaviour
2%
Irritability
2%
Urinary tract infection
2%
Varicella
2%
Toxicity to various agents
2%
Hepatic enzyme increased
2%
Nasopharyngitis
2%
Blood pressure diastolic increased
2%
Constipation
2%
Gait disturbance
2%
Influenza
2%
Sinusitis
2%
Fall
2%
Hypotonia
2%
Seizure
2%
Urinary incontinence
2%
Rhinorrhoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Study 3: ZX008 0.8 mg/kg/Day
Study 1: Placebo
Study 1: ZX008 0.2 mg/kg/Day
Study 1: ZX008 0.8 mg/kg/Day
Study 3: Placebo
Study 3: ZX008 0.2 mg/kg/Day

Trial Design

1Treatment groups
Experimental Treatment
Group I: ZX008 (Fenfluramine Hydrochloride)Experimental Treatment1 Intervention
ZX008 is supplied as an open-label oral solution.Doses will include up to 0.8 mg/kg/day divided into 2 daily doses, up to a maximum of 30 mg/day (subjects taking concomitant STP will receive up to 0.5 mg/kg/day, up to a maximum of 20 mg/day) in a concentration of 2.5 mg/mL.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ZX008 (Fenfluramine Hydrochloride)
2016
Completed Phase 3
~730

Find a Location

Who is running the clinical trial?

Zogenix, Inc.Lead Sponsor
24 Previous Clinical Trials
2,161 Total Patients Enrolled
Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.Industry Sponsor
11 Previous Clinical Trials
1,333 Total Patients Enrolled
UCB CaresStudy Director001 844 599 2273
203 Previous Clinical Trials
43,950 Total Patients Enrolled

Media Library

ZX008 (Fenfluramine Hydrochloride) (Serotonin Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT03936777 — Phase 3
Epileptic Encephalopathy Research Study Groups: ZX008 (Fenfluramine Hydrochloride)
Epileptic Encephalopathy Clinical Trial 2023: ZX008 (Fenfluramine Hydrochloride) Highlights & Side Effects. Trial Name: NCT03936777 — Phase 3
ZX008 (Fenfluramine Hydrochloride) (Serotonin Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03936777 — Phase 3

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

Where is this research being conducted?

"This trial is currently being conducted out of several locations including Vancouver, Atlanta and Montreal."

Answered by AI

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."

Answered by AI

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/"

Answered by AI

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."

Answered by AI

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."

Answered by AI
~13 spots leftby Jun 2024