An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride HCl) Oral Solution in Children and Young Adults With Dravet Syndrome



Status:Enrolling by invitation
Healthy:No
Age Range:2 - 35
Updated:11/17/2018
Start Date:June 2016
End Date:December 2019

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An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride HCl) Oral Solution as an Adjunctive Therapy in Children and Young Adults With Dravet Syndrome

This is an international, multicenter, open-label, long-term safety study of ZX008 in
subjects with Dravet syndrome.

This is an international, multicenter, open-label, long-term safety study of ZX008 in
pediatric and young adult subjects with Dravet syndrome who participated in one of the core
studies (ZX008-1501 and ZX008-1502) and are candidates for continuous treatment for an
extended period of time. This trial will consist of a 36-month Open-Label Extension (OLE)
Treatment Period and a 2-week Post-Dosing Period.

Key Inclusion Criteria:

- Male or non-pregnant, non-lactating female, age 2 to 18 years, inclusive as of the day
of the core study Screening Visit.

- Satisfactory completion of the core study in the opinion of the investigator and the
sponsor.

- Subjects who are >18 to ≤35 years of age at the time of screening and did not
participate in one of the core studies may be eligible for participation.

- A documented medical history to support a clinical diagnosis of Dravet syndrome, where
convulsive seizures are not completely controlled by current antiepileptic drugs.

- Parent/caregiver is willing and able to be compliant with diary completion, visit
schedule and study drug accountability.

- Subject's parent/caregiver has been compliant with diary completion during the core
study, in the opinion of the investigator (eg, at least 90% compliant).

Key Exclusion Criteria:

- Current or past history of cardiovascular or cerebrovascular disease, myocardial
infarction or stroke.

- Current cardiac valvulopathy or pulmonary hypertension that is clinically significant
and warrants discontinuation of study medication.

- Current or past history of glaucoma.

- Moderate or severe hepatic impairment.

- 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, and/or cytochrome P450 (CYP) 2D6/3A4/2B6 inhibitors/substrates.

- Currently taking carbamazepine, oxcarbamazepine, eslicarbazepine, phenobarbital, or
phenytoin, or has taken any of these within the past 30 days, as maintenance therapy.

- A clinically significant condition, or has had clinically relevant symptoms or a
clinically significant illness at Visit 1, other than epilepsy, that would negatively
impact study participation, collection of study data, or pose a risk to the subject.
We found this trial at
24
sites
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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3020 Childrens way
San Diego, California 92123
(858) 576-1700
Rady Children's Hospital - San Diego Rady Children's Hospital-San Diego is the region’s pediatric medical...
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Atlanta, Georgia 30328
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Charlotte, North Carolina 28210
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Chicago, Illinois 60611
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Gulf Breeze, Florida 32561
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Hackensack, New Jersey 07601
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6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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Livingston, New Jersey 07039
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Long Beach, California 90806
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Orlando, Florida 32819
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Rochester, Minnesota 55905
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Sacramento, California 95816
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San Francisco, California 94143
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Seattle, Washington 98122
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4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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Tucson, Arizona 85718
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