Status:
COMPLETED
A Study to Investigate the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) as an Adjunctive Therapy in Children and Adults With Lennox-Gastaut Syndrome
Lead Sponsor:
Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
Conditions:
Lennox Gastaut Syndrome
Eligibility:
All Genders
2-35 years
Phase:
PHASE3
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 ch...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2024
Estimated Enrollment :
296 Patients enrolled
Trial Details
Trial ID
NCT03355209
Start Date
November 27 2017
End Date
May 23 2024
Last Update
July 3 2025
Active Locations (72)
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