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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03355209
Date of registration: 19/06/2017
Prospective Registration: Yes
Primary sponsor: Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
Public title: A Study to Investigate the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) as an Adjunctive Therapy in Children and Adults With Lennox-Gastaut Syndrome
Scientific title: 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
Date of first enrolment: November 27, 2017
Target sample size: 225
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03355209
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 3
Countries of recruitment
Australia Austria Belgium Canada Denmark France Germany Italy
Japan Mexico Netherlands Poland Spain Sweden United States
Contacts
Name:     ZX008 Clinical Trials Information Desk
Address: 
Telephone: 510-338-9968
Email: ClinStudyInfo@zogenix.com
Affiliation: 
Key inclusion & exclusion criteria

Key Inclusion Criteria:

- 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.



Age minimum: 2 Years
Age maximum: 35 Years
Gender: All
Health Condition(s) or Problem(s) studied
Lennox Gastaut Syndrome
Intervention(s)
Drug: Matching Placebo
Drug: ZX008 0.2 or 0.8 mg/kg/day
Primary Outcome(s)
Part 1: Change from baseline in frequency of seizures that result in drops in subjects receiving ZX008 compared to placebo [Time Frame: Up to 20 weeks maintenance and taper period (T+M)]
Secondary Outcome(s)
Part 2: Adverse events and related safety parameters in subjects receiving ZX008 compared to placebo [Time Frame: Up to 12 months open label]
Secondary ID(s)
ZX008-1601
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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