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Serotonin Receptor Agonist
Fenfluramine for Infantile Spasms
Phase 2
Recruiting
Led By Shaun Hussain, MD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Children ages 12 to 36 months, inclusive
Clinical diagnosis of infantile spasms
Must not have
Implantation of a vagal nerve simulator within 14 days of screening
Significant preexisting cardiovascular disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Summary
This trial will test if fenfluramine is an effective treatment for children with infantile spasms who have not responded to other treatments.
Who is the study for?
This trial is for children aged 1 to 3 with infantile spasms that haven't improved after treatment with ACTH and vigabatrin. Kids can't join if they have serious heart problems, used cannabinoids recently, started a new spasm treatment or diet, or got a vagal nerve stimulator in the last few weeks.Check my eligibility
What is being tested?
The study tests fenfluramine's effectiveness and safety in treating stubborn infantile spasms. Over three weeks, kids will take the drug and have two video-EEGs before and after to see if it works. Responders may continue for six months.See study design
What are the potential side effects?
While not specified here, fenfluramine could potentially cause appetite changes, mood swings, sleep disturbances, digestive issues or heart-related side effects based on its known profile.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child is between 1 and 3 years old.
Select...
My child has been diagnosed with infantile spasms.
Select...
My seizures have not stopped despite treatment with ACTH and vigabatrin.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I had a vagal nerve stimulator implanted within the last 14 days.
Select...
I have a serious heart condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Electroclinical response (Efficacy)
Secondary outcome measures
Computational electroencephalography response (Efficacy)
Incidence of treatment emergent adverse events (Safety and tolerability)
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: Fenfluramine treatmentExperimental Treatment1 Intervention
Open label treatment with fenfluramine. Dosage will be titrated to 0.8 mg/kg/day, for an initial duration of 21 days. Patients with favorable response will have an option to continue treatment for up to 6 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fenfluramine
FDA approved
Find a Location
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,541 Previous Clinical Trials
10,267,033 Total Patients Enrolled
Children's Hospital of Orange CountyLead Sponsor
32 Previous Clinical Trials
4,924 Total Patients Enrolled
Shaun Hussain, MDPrincipal InvestigatorUniveristy of California, Los Angeles
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My child is between 1 and 3 years old.You started and kept on a ketogenic diet within 3 months before the screening.My child has been diagnosed with infantile spasms.I had a vagal nerve stimulator implanted within the last 14 days.You have used any products containing cannabinoids in the two weeks before screening.I haven't started or changed the dose of my infantile spasms treatment in the last 14 days.My seizures have not stopped despite treatment with ACTH and vigabatrin.I have a serious heart condition.
Research Study Groups:
This trial has the following groups:- Group 1: Fenfluramine treatment
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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