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Serotonin Receptor Agonist
Fenfluramine for Dravet Syndrome
Phase 3
Waitlist Available
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 week
Awards & highlights
Study Summary
This trial is studying fenfluramine as a possible treatment for adults with Dravet syndrome who have seizures that can't be controlled with other medications.
Who is the study for?
Adults over 18 with drug-resistant epilepsy and genetically confirmed Dravet syndrome, experiencing at least four convulsive seizures per month despite treatment. Participants must not have certain cardiovascular conditions or be using CBD oil, among other criteria.Check my eligibility
What is being tested?
Fenfluramine (FINTEPLA) is being tested for its effectiveness in reducing seizure frequency and improving quality of life in adult Dravet patients. The trial includes a baseline phase, titration, treatment period, extension for responders, and post-trial washout.See study design
What are the potential side effects?
Potential side effects may include changes in body weight, cardiovascular issues such as pulmonary hypertension or valvulopathy (heart valve problems), which will be closely monitored during the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 week
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 week
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Seizure reduction
Side effects data
From 2020 Phase 3 trial • 262 Patients • NCT0268292738%
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: FenfluramineExperimental Treatment1 Intervention
Fenfluramine, oral,
starting at 0.1mg/kg twice daily, maximum 26mg/day in patients not taking concomitant stiripentol
starting at 0.1mg/kg twice daily, maximum 17mg/day in patients taking concomitant stiripentol
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fenfluramine
2021
Completed Phase 4
~60
Find a Location
Who is running the clinical trial?
Zogenix, Inc.Industry Sponsor
24 Previous Clinical Trials
2,558 Total Patients Enrolled
University Health Network, TorontoLead Sponsor
1,468 Previous Clinical Trials
484,504 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a serious health condition other than epilepsy that could affect your safety or participation in the trial.You have high blood pressure in your lungs.You have heart or blood vessel disease.You must be taking your current medication as directed.You have had glaucoma in the past or have it now.You are allergic to FEN or any ingredients in the study medication.You are using CBD oil.Adults 18 years and older with Down syndrome and a confirmed genetic issue causing the condition.Patients who are referred from specific epilepsy clinics in Toronto or other academic epilepsy centers in Ontario are included in the study.You have at least 4 seizures every month, even after trying two different seizure medications for a year.You have a history of heart or blood vessel problems, such as significant aortic valve issues.You are taking certain medications that affect your mood or appetite.
Research Study Groups:
This trial has the following groups:- Group 1: Fenfluramine
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still unfilled positions for participants in this research?
"Although this study is not looking for new patients at the moment, that may change in the future. The clinical trial was initially posted on December 10th, 2022 and was last updated on November 8th, 2022. There are 1,448 other trials currently recruiting participants."
Answered by AI
Could you please summarize Fenfluramine's side effects?
"Fenfluramine's safety is estimated to be a 3. This Phase 3 rating comes from supporting data of efficacy as well as multiple rounds of safe patient usage."
Answered by AI
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