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Serotonin Receptor Agonist

Fenfluramine for Dravet and Lennox-Gastaut Syndromes

Phase 3

Waitlist Available

Research Sponsored by Zogenix, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must not have

Current clinically significant cardiac valvulopathy or pulmonary hypertension

Moderate or severe hepatic impairment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 months open-label

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new drug for safety in people with Dravet syndrome, Lennox-Gastaut syndrome or epileptic encephalopathy.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed here, potential side effects may include those related to fenfluramine's known risks such as heart-related issues, changes in mood or behavior, digestive disturbances and possible impacts on growth and weight.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious heart valve problem or high blood pressure in my lungs.

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My liver is not working well.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months open-label

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36 months open-label

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months open-label for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Adverse Events and Serious Adverse Events leading to study withdrawal in subjects receiving open label ZX008

Change in body weight

Changes in blood pressure

+5 more

Secondary study objectives

Change in Behavioral CGI by Investigator

Change in Behavioral CGI by Parent/Caregiver

Change in Clinical Global Impression by Investigator

+6 more

Side effects data

From 2020 Phase 3 trial • 262 Patients • NCT02682927

26%

Decreased appetite

24%

Blood glucose decreased

24%

Echocardiogram abnormal

15%

Diarrhoea

11%

Somnolence

11%

Pyrexia

Nasopharyngitis

Rhinorrhoea

Blood pressure diastolic increased

Gait disturbance

Ear infection

Fatigue

Upper respiratory tract infection

Sinusitis

Status epilepticus

Viral infection

Cough

Constipation

Asthenia

Irritability

Blood pressure increased

Urinary tract infection

Skull fracture

Croup infectious

Heart rate increased

Tremor

Influenza

Seizure

Blood prolactin increased

Respiratory distress

Gastroenteritis

Lethargy

Salivary hypersecretion

Drooling

Headache

Seizure cluster

Abnormal behaviour

Weight decreased

100%

80%

60%

40%

20%

Study treatment Arm

Study 3: ZX008 0.2 mg/kg/Day

Study 1: ZX008 0.2 mg/kg/Day

Study 1: ZX008 0.8 mg/kg/Day

Study 3: Placebo

Study 3: ZX008 0.8 mg/kg/Day

Study 1: Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: ZX008 (Fenfluramine Hydrochloride)Experimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ZX008 (Fenfluramine Hydrochloride)

2016

Completed Phase 3

~730

0 / 2Eligibility criteria met