Fenfluramine for Dravet and Lennox-Gastaut Syndromes

Recruiting at 157 trial locations

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Zogenix, Inc.

Must not be taking: Monoamine oxidase inhibitors, serotonin agonists

Disqualifiers: Cardiac valvulopathy, pulmonary hypertension, hepatic impairment, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

412 Participants Needed

Trial Summary

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

Research Team

UCB Cares

Principal Investigator

001 844 599 2273

Eligibility Criteria

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

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.

Treatment Details

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.

Participant Groups

Group I: ZX008 (Fenfluramine Hydrochloride) Experimental Treatment 1 Intervention

ZX008 is supplied as an open-label oral solution.Doses will include up to 0.8 mg/kg/day divided into 2 daily doses, up to a maximum of 30 mg/day (subjects taking concomitant STP will receive up to 0.5 mg/kg/day, up to a maximum of 20 mg/day) in a concentration of 2.5 mg/mL.

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

Approved in European Union as Fintepla for:

• Dravet syndrome
• Lennox-Gastaut syndrome
• CDKL5 deficiency disorder

Approved in United States as Fintepla for:

• Dravet syndrome
• Lennox-Gastaut syndrome
• CDKL5 deficiency disorder

Approved in Japan as Fintepla for:

• Dravet syndrome
• Lennox-Gastaut syndrome
• CDKL5 deficiency disorder

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+