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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study 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 below

Select...

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

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 • NCT02682927

38%

Decreased appetite

21%

Somnolence

19%

Pyrexia

17%

Blood glucose decreased

17%

Echocardiogram abnormal

15%

Diarrhoea

13%

Tremor

10%

Fatigue

Upper respiratory tract infection

Platelet count decreased

Weight decreased

Rash

Cough

Vomiting

Lethargy

Asthenia

Hypoglycaemia

Drooling

Viral infection

Rhinitis

Blood pressure increased

Ataxia

Balance disorder

Abnormal behaviour

Irritability

Urinary tract infection

Varicella

Toxicity to various agents

Hepatic enzyme increased

Nasopharyngitis

Blood pressure diastolic increased

Constipation

Gait disturbance

Influenza

Sinusitis

Fall

Hypotonia

Seizure

Urinary incontinence

Rhinorrhoea

100%

80%

60%

40%

20%

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor

1,532 Previous Clinical Trials

10,265,258 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

Fenfluramine (Serotonin Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04289467 — Phase 2

Infantile Spasms Research Study Groups: Fenfluramine treatment

Infantile Spasms Clinical Trial 2023: Fenfluramine Highlights & Side Effects. Trial Name: NCT04289467 — Phase 2

Fenfluramine (Serotonin Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04289467 — Phase 2

Frequently Asked Questions

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

Does the trial have any age restrictions, specifically for individuals over 35?

"This trial is intended for those aged between 1 year and 3 years old. There are 11 separate trials available to minors, while 9 other studies target people over 65."

Answered by AI

Do I meet the qualifications to be included in this research?

"Eligibility requirements state that the accepted patients must have infantile spasms and be between 12 months and 36 months of age. This clinical trial is looking to recruit approximately 10 individuals who meet these criteria."

Answered by AI

Are there any risks associated with utilizing Fenfluramine as a therapeutic option?

"The safety profile of fenfuramine was rated a 2 out of 3 points due to the fact that only preliminary evidence exists regarding its efficacy, which is standard for Phase 2 trials."

Answered by AI

What have prior investigations demonstrated about Fenfluramine as a form of treatment?

"Presently, there are 5 ongoing studies into the efficacy of Fenfluramine with 4 in Phase 3. Most trials occur in Boston, MA; however, 188 clinical trial sites exist throughout the country offering this treatment option."

Answered by AI

Could you provide a numerical estimate of the participants in this trial?

"This research endeavour is no longer accepting patients, having been first posted on September 1st 2023 and last modified four months later. If you are still seeking a medical study to participate in, there currently exist 13 trials involving infantile spasms as well as 5 clinical tests researching the efficacy of Fenfluramine treatment."

Answered by AI

Does this research represent a unique approach?

"To-date, 5 ongoing studies of Fenfluramine treatment are being conducted in 57 cities and 15 nations. The pioneering research was done by Zogenix International Limited, Inc., a subdivision of Zogenix, Inc.. This trial had 296 participants and has since achieved Phase 3 drug approval status; 7 other investigations have concluded their experiments since 2017."

Answered by AI

Are there any open enrollment requirements for this research project?

"This research endeavour is no longer recruiting participants, as it was first posted on September 1st 2023 and last updated April 12th of the same year. If you are still seeking active trials, 13 studies in total are currently enrolling those with infantile spasms while 5 more clinical trials require Fenfluramine treatment candidates."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Treatment of Refractory Infantile Spasms With Fenfluramine

Daniel Shrey 2023. "Treatment of Refractory Infantile Spasms With Fenfluramine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04289467.

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