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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

All Individual Drugs Already Approved

No Placebo-Only Group

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.

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.

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

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My child is between 1 and 3 years old.

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My child has been diagnosed with infantile spasms.

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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:

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I had a vagal nerve stimulator implanted within the last 14 days.

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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

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Electroclinical response (Efficacy)

Secondary study objectives

Computational electroencephalography response (Efficacy)

Incidence of treatment emergent adverse events (Safety and tolerability)

Awards & Highlights

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.

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 / 5Eligibility criteria met