Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New hope for rare seizure patients: Long-Term drug safety confirmed

NCT ID NCT03936777

Disease control Sponsor: Zogenix, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at the long-term safety of a drug called fenfluramine (ZX008) for people with rare seizure disorders like Dravet syndrome and Lennox-Gastaut syndrome. A total of 412 participants who had completed earlier studies took the drug and were monitored for side effects. The main goal was to see how safe the drug is over time, not to cure the condition.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

412 people

The number who actually took part.

Started

Apr 2019

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or nonpregnant, nonlactating female * Satisfactory completion of a core study * Has a rare seizure disorder, such as epileptic encephalopathy and has successfully completed another Zogenix-sponsored clinical trials with ZX008 * Subject's caregiver is willing and able to be compliant with study procedures, visit schedule and study drug accountability Exclusion Criteria: * Current cardiac valvulopathy or pulmonary hypertension that is clinically significant * Moderate or severe hepatic impairment * Receiving monoamine oxidase inhibitors, serotonin agonists, serotonin antagonists, and serotonin reuptake inhibitors within 14 days of receiving ZX008

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Dravet syndrome are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

developmental and epileptic encephalopathy Dravet syndrome Epilepsies, Myoclonic Lennox-Gastaut syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dravet syndrome Epileptic encephalopathy Lennox Gastaut syndrome

Contacts and locations

Locations

  • Ep0215 1001

    Paris, France

  • Ep0215 1002

    Paris, France

  • Ep0215 1004

    Bordeaux, France

  • Ep0215 1005

    Lille, France

  • Ep0215 1007

    Marseille, France

  • Ep0215 1008

    Salouël, France

  • Ep0215 101

    San Francisco, California, 94158, United States

  • Ep0215 103

    Aurora, Colorado, 80045, United States

  • Ep0215 104

    Miami, Florida, 33155, United States

  • Ep0215 105

    Hackensack, New Jersey, 07601, United States

  • Ep0215 106

    Salt Lake City, Utah, 84108, United States

  • Ep0215 107

    Tucson, Arizona, 85718, United States

  • Ep0215 108

    San Diego, California, 92123, United States

  • Ep0215 109

    Rochester, Minnesota, 55905, United States

  • Ep0215 110

    Chicago, Illinois, 60611-2605, United States

  • Ep0215 1101

    Madrid, Spain

  • Ep0215 1102

    Pamplona, Spain

  • Ep0215 1103

    Esplugues de Llobregat, Spain

  • Ep0215 1105

    Barcelona, Spain

  • Ep0215 1107

    Barcelona, Spain

  • Ep0215 112

    Boston, Massachusetts, 02114, United States

  • Ep0215 115

    Gulf Breeze, Florida, 32561, United States

  • Ep0215 117

    Atlanta, Georgia, 30328, United States

  • Ep0215 118

    Livingston, New Jersey, 07039, United States

  • Ep0215 119

    Seattle, Washington, 98105, United States

  • Ep0215 1201

    Florence, Italy

  • Ep0215 1202

    Verona, Italy

  • Ep0215 1204

    Genova, Italy

  • Ep0215 1205

    Mantua, Italy

  • Ep0215 1206

    Roma, Italy

  • Ep0215 1207

    Milan, Italy

  • Ep0215 1208

    Roma, Italy

  • Ep0215 121

    Winter Park, Florida, 32789, United States

  • Ep0215 124

    Memphis, Tennessee, 38103, United States

  • Ep0215 125

    Tacoma, Washington, 98405, United States

  • Ep0215 126

    Fort Worth, Texas, 76104, United States

  • Ep0215 131

    Cleveland, Ohio, 44106, United States

  • Ep0215 132

    Roseville, Minnesota, 55113, United States

  • Ep0215 140

    Bethesda, Maryland, 20817, United States

  • Ep0215 1401

    Zwolle, Netherlands

  • Ep0215 1402

    Heeze, Netherlands

  • Ep0215 141

    Orlando, Florida, 32803, United States

  • Ep0215 142

    New York, New York, 10016, United States

  • Ep0215 144

    Los Angeles, California, 90095, United States

  • Ep0215 146

    Dallas, Texas, 75207, United States

  • Ep0215 150

    Hawthorne, New York, 10532, United States

  • Ep0215 1604

    Guadalajara, Mexico

  • Ep0215 1701

    Krakow, Poland

  • Ep0215 1702

    Bydgoszcz, Poland

  • Ep0215 201

    Vancouver, Canada

  • Ep0215 202

    Montreal, Canada

  • Ep0215 204

    Toronto, Canada

  • Ep0215 301

    Heidelberg, Australia

  • Ep0215 302

    South Brisbane, Australia

  • Ep0215 303

    Westmead, Australia

  • Ep0215 502

    Gothenburg, Sweden

  • Ep0215 601

    Glasgow, United Kingdom

  • Ep0215 602

    London, United Kingdom

  • Ep0215 603

    Liverpool, United Kingdom

  • Ep0215 605

    Birmingham, United Kingdom

  • Ep0215 606

    London, United Kingdom

  • Ep0215 701

    Dianalund, Denmark

  • Ep0215 801

    Edegem, Belgium

  • Ep0215 802

    Jette, Belgium

  • Ep0215 803

    Brussels, Belgium

  • Ep0215 901

    Vogtareuth, Germany

  • Ep0215 902

    Bielefeld, Germany

  • Ep0215 903

    Radeberg, Germany

  • Ep0215 905

    Jena, Germany

  • Ep0215 906

    Freiburg im Breisgau, Germany

  • Ep0215 908

    Kiel, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.