NCT03355209CompletedPhase 3
A Study to Investigate the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) as an Adjunctive Therapy in Children and Adults With Lennox-Gastaut Syndrome
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
Source: ClinicalTrials.gov · Last updated 3 Jul 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 296 (actual)
- First submitted
- 19 Jun 2017
- Start date
- 27 Nov 2017
- Primary completion date
- 23 May 2024
- Lead sponsor
- Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
- Diseases
- Epilepsy
- NCT number
- NCT03355209
- EudraCT number
- 2017-002628-26
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 296
- From 27 Nov 2017 to the primary completion date, 23 May 2024
- 72 sites in 14 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Currently receiving an investigational product.
- 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.
Other illness
- 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.
- Institutionalized in a general nursing home (ie, in a facility that does not specialize in epilepsy care).
Lab values
- 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.
Who the study is looking for
- 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.
Age in the registry: 2 years to 35 years · Sex: All · Does not accept healthy volunteers
Sites (72)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.