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ZX008-1601

A Two-Part Study of ZX008 in Children and Adults with Lennox-Gastaut Syndrome (LGS); Part 1: A Randomized, Double-blind, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as Adjunctive Therapy for Seizures in Children and Adults with LGS, Followed by Part 2: An Open-label Extension to Assess Long-Term Safety of ZX008 in Children and Adults with LGS

Brief summary

This is a two-part, multicenter, double-blind, parallel-group, placebo controlled study to evaluate the effect of ZX008 when used as adjunctive therapy for the treatment of uncontrolled seizures in children and adults with Lennox-Gastaut syndrome (LGS).

Medical Condition

Lennox Gastaut Syndrome

Min. Age

2
Years

Max. Age

35
Years

Who Can Join?

All

Status

Active, not recruiting
Inclusion criteria
Key • Male or non-pregnant, non-lactating female, age 2 to 35 years, inclusive as of the day of the Screening Visit. • Clinical diagnosis of Lennox-Gastaut syndrome, where seizures that result in drops are not completely controlled by current antiepileptic treatments. • Onset of seizures at 11 years of age or younger. • Abnormal cognitive development. • Must be receiving at least 1 concomitant AED and up to 4 concomitant anti-epileptic treatments. Key
Exclusion criteria
• Etiology of seizures is a degenerative neurological disease. • History of hemiclonic seizures in the first year of life. • Subject only has drop seizures in clusters, where individual seizures cannot be counted reliably. • Pulmonary arterial hypertension. • Current or past history of cardiovascular or cerebrovascular disease, such as cardiac valvulopathy, myocardial infarction or stroke. • Receiving concomitant therapy with: centrally-acting anorectic agents; monoamineoxidase inhibitors; any centrally-acting compound with clinically appreciable amount of serotonin agonist or antagonist properties, including serotonin reuptake inhibition; atomoxetine, or other centrally-acting noradrenergic agonist; cyproheptadine. • Taking felbamate for less than 1 year prior to screening and/or does not have stable liver function and hematology laboratory tests, and/or the dose has not been stable for at least 60 days prior to the Screening Visit. • Currently receiving an investigational product. • Institutionalized in a general nursing home (ie, in a facility that does not specialize in epilepsy care). • A clinically significant condition, or has had clinically relevant symptoms or a clinically significant illness in the 4 weeks prior to the Screening Visit, other than epilepsy, that would negatively impact study participation, collection of study data, or pose a risk to the subject.

Study Medication Description

Study Medication:

Fintepla

Other Descriptive Name:

fenfluramine hydrochloride

Placebo

Yes

Comparator:

No

Study Dates

November 2017

Actual Start Date of Enrollment

January 2025

Planned Study Completion Date

General Information

Study ID:
ZX008-1601
CT.gov Number:
NCT03355209
Phase:
Phase 3

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