A Study to Investigate the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) as an Adjunctive Therapy in Children and Adults With Lennox-Gastaut Syndrome
- Conditions
- Lennox Gastaut Syndrome
- Interventions
- Drug: Matching PlaceboDrug: ZX008 0.2 or 0.8 mg/kg/day
- Registration Number
- NCT03355209
- Lead Sponsor
- Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
- 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 children and adults with Lennox-Gastaut syndrome (LGS).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 296
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Matching Placebo Matching Placebo Part 1: Matching ZX008 placebo is supplied as an oral solution. ZX008 0.2 or 0.8 mg/kg/day ZX008 0.2 or 0.8 mg/kg/day Part 1: ZX008 is supplied as an oral solution. Subjects will be randomized to receive 1 of 2 doses of ZX008 0.2 mg/kg/day or 0.8 mg/kg/day. Open-Label ZX008 0.2 or 0.8 mg/kg/day Part 2: ZX008 is supplied as an oral solution. Study medication will be administered twice a day (BID) in equally divided doses.
- Primary Outcome Measures
Name Time Method Part 1: Change from baseline in frequency of seizures that result in drops in subjects receiving ZX008 compared to placebo Up to 20 weeks maintenance and taper period (T+M) Parent/caregiver seizure diary record will be used to assess frequency, type and duration of seizure activity
- Secondary Outcome Measures
Name Time Method Part 2: Adverse events and related safety parameters in subjects receiving ZX008 compared to placebo Up to 12 months open label Safety and tolerability evaluated by reported adverse events, laboratory parameters, physical and neurological examination, vital signs, electrocardiograms, echocardiograms, and body weight
Related Research Topics
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Trial Locations
- Locations (72)
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🇺🇸Los Angeles, California, United States
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🇺🇸Atlanta, Georgia, United States
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🇺🇸Gulf Breeze, Florida, United States
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🇺🇸Hackensack, New Jersey, United States
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🇺🇸Dallas, Texas, United States
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🇦🇺Heidelberg, Australia
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🇧🇪Brussels, Belgium
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🇩🇪Kiel, Germany
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🇩🇪Vogtareuth, Germany
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🇺🇸Chicago, Illinois, United States
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🇺🇸San Antonio, Texas, United States
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🇺🇸Salt Lake City, Utah, United States
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🇫🇷Lille Cedex, France
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🇺🇸San Francisco, California, United States
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🇺🇸Washington, District of Columbia, United States
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🇺🇸Miami, Florida, United States
Ep0214 121
🇺🇸Orlando, Florida, United States
Ep0214 140
🇺🇸Bethesda, Maryland, United States
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🇺🇸Boston, Massachusetts, United States
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🇺🇸Grand Rapids, Michigan, United States
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🇺🇸Saint Paul, Minnesota, United States
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🇺🇸New York, New York, United States
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🇺🇸Cleveland, Ohio, United States
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🇺🇸Fort Worth, Texas, United States
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🇺🇸York, Pennsylvania, United States
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🇺🇸Tacoma, Washington, United States
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🇧🇪Bruxelles, Belgium
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🇦🇺South Brisbane, Australia
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🇨🇦Toronto, Canada
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🇨🇦Vancouver, Canada
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🇩🇰Dianalund, Denmark
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🇫🇷Bordeaux Cedex, France
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🇫🇷Bron, France
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🇫🇷Marseilles, France
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🇩🇪Freiburg, Germany
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🇫🇷Paris, France
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🇫🇷Paris, France
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🇩🇪Bielefeld, Germany
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🇩🇪Radeberg, Germany
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🇩🇪Jena, Germany
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🇮🇹Bologna, Italy
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🇮🇹Genova, Italy
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🇮🇹Firenze, Italy
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🇮🇹Roma, Italy
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🇮🇹Roma, Italy
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🇯🇵Osaka, Japan
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🇯🇵Omura, Japan
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🇯🇵Okayama, Japan
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🇯🇵Sapporo-city, Japan
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🇯🇵Shizuoka, Japan
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🇳🇱Zwolle, Netherlands
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🇲🇽Guadalajara, Mexico
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🇵🇱Bydgoszcz, Poland
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🇵🇱Krakow, Poland
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🇪🇸Barcelona, Spain
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🇪🇸Mirasierra, Spain
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🇪🇸Barcelona, Spain
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🇸🇪Göteborg, Sweden
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🇪🇸Pamplona, Spain
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🇺🇸Hartsdale, New York, United States
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🇺🇸Royal Oak, Michigan, United States
Ep0214 120
🇺🇸Philadelphia, Pennsylvania, United States
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🇺🇸Aurora, Colorado, United States
Ep0214 109
🇺🇸Rochester, Minnesota, United States
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🇺🇸Portland, Oregon, United States
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🇺🇸Orlando, Florida, United States
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🇧🇪Edegem, Belgium
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🇺🇸Livingston, New Jersey, United States
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🇺🇸Tucson, Arizona, United States
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🇯🇵Fukuoka, Japan
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🇯🇵Shinjuku-ku, Japan
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🇯🇵Niigata-city, Japan