412 Participants Needed

Fenfluramine for Dravet and Lennox-Gastaut Syndromes

Recruiting at 157 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This is an international, multicenter, open-label, long-term safety study of ZX008 in subjects with Dravet syndrome, Lennox-Gastaut syndrome or epileptic encephalopathy

Who Is on the Research Team?

UC

UCB Cares

Principal Investigator

001 844 599 2273

Are You a Good Fit for This Trial?

This trial is for children and adults with rare seizure disorders like Dravet syndrome or Lennox-Gastaut syndrome, who have completed a prior Zogenix study. Participants must not be pregnant, breastfeeding, have serious liver issues, heart valve problems or pulmonary hypertension, nor take certain medications affecting serotonin within 14 days of the trial.

Inclusion Criteria

You have a rare seizure disorder like epileptic encephalopathy and have finished another Zogenix-sponsored trial with ZX008.
I am a man or a woman not pregnant or breastfeeding.
Satisfactory completion of a core study
See 1 more

Exclusion Criteria

I have a serious heart valve problem or high blood pressure in my lungs.
I haven't taken any depression or migraine medications in the last 14 days.
My liver is not working well.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ZX008 (Fenfluramine Hydrochloride) oral solution as an adjunctive therapy for seizures

Up to 36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Open-label extension

Participants continue to receive ZX008 for an extended period to assess long-term safety

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • ZX008 (Fenfluramine Hydrochloride)
Trial Overview The study tests the long-term safety of ZX008 (Fenfluramine Hydrochloride) oral solution in patients with specific epileptic encephalopathies. It's an international study where all participants receive the drug to see how it affects them over time.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: ZX008 (Fenfluramine Hydrochloride)Experimental Treatment1 Intervention

ZX008 (Fenfluramine Hydrochloride) is already approved in European Union, United States, Japan for the following indications:

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Approved in European Union as Fintepla for:
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Approved in United States as Fintepla for:
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Approved in Japan as Fintepla for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Zogenix, Inc.

Lead Sponsor

Trials
25
Recruited
2,600+

Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.

Industry Sponsor

Trials
12
Recruited
1,700+
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