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 |
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).
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.
We found this trial at
32
sites
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
![Oregon Health and Science University](/wp-content/uploads/logos/oregon-health-and-science-university.jpg)
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
University of Utah Research is a major component in the life of the U benefiting...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
5887 Glenridge Drive
Atlanta, Georgia 30328
Atlanta, Georgia 30328
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
111 Michigan Ave NW
Washington, District of Columbia
Washington, District of Columbia
(202) 476-5000
![Childrens National Medical Center](/wp-content/uploads/logos/childrens-national-medical-center.jpg)
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)