A Study to Investigate the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) as an Adjunctive Therapy in Children and Adults With Lennox-Gastaut Syndrome



Status:Recruiting
Healthy:No
Age Range:2 - 35
Updated:2/28/2019
Start Date:November 27, 2017
End Date:December 2019
Contact:Betty J Quarles, B.S.
Email:Bquarles@zogenix.com
Phone:510-375-5357

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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

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).


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.
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Los Angeles, California 90095
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7485 Sandlake Commons Blvd.
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South 34th Street
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
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201 Presidents Circle
Salt Lake City, Utah 84108
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University of Utah Research is a major component in the life of the U benefiting...
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2450 E. River Road
Tucson, Arizona 85718
520-320-2147
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5887 Glenridge Drive
Atlanta, Georgia 30328
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13123 E 16th Ave
Aurora, Colorado 80045
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Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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Boston, Massachusetts 02114
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2201 Inwood Rd
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Grand Rapids, Michigan 49503
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4800 Sand Point Way NE
Seattle, Washington 98105
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Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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111 Michigan Ave NW
Washington, District of Columbia
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Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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