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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03355209
Other study ID # ZX008-1601
Secondary ID 2017-002628-26
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date November 27, 2017
Est. completion date July 1, 2024

Study information

Verified date April 2024
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 296
Est. completion date July 1, 2024
Est. primary completion date July 1, 2024
Accepts healthy volunteers No
Gender All
Age group 2 Years to 35 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ZX008 0.2 or 0.8 mg/kg/day
ZX008 drug product is an oral aqueous solution of fenfluramine hydrochloride. The product is sugar free and is intended to be compatible with a Ketogenic Diet.
Matching Placebo
Placebo will be administered twice a day (BID) in equally divided doses.

Locations

Country Name City State
Australia Ep0214 301 Heidelberg
Australia Ep0214 302 South Brisbane
Belgium Ep0214 802 Brussels
Belgium Ep0214 803 Bruxelles
Belgium Ep0214 801 Edegem
Canada Ep0214 204 Toronto
Canada Ep0214 201 Vancouver
Denmark Ep0214 701 Dianalund
France Ep0214 1004 Bordeaux Cedex
France Ep0214 1006 Bron
France Ep0214 1005 Lille Cedex
France Ep0214 1007 Marseilles
France Ep0214 1001 Paris
France Ep0214 1002 Paris
Germany Ep0214 902 Bielefeld
Germany Ep0214 906 Freiburg
Germany Ep0214 905 Jena
Germany Ep0214 908 Kiel
Germany Ep0214 903 Radeberg
Germany Ep0214 901 Vogtareuth
Italy Ep0214 1211 Bologna
Italy Ep0214 1201 Firenze
Italy Ep0214 1204 Genova
Italy Ep0214 1206 Roma
Italy Ep0214 1208 Roma
Japan Ep0214 1510 Fukuoka
Japan Ep0214 1505 Niigata-city
Japan Ep0214 1501 Okayama
Japan Ep0214 1504 Omura
Japan Ep0214 1507 Osaka
Japan Ep0214 1508 Sapporo-city
Japan Ep0214 1506 Shinjuku-ku
Japan Ep0214 1502 Shizuoka
Mexico Ep0214 1604 Guadalajara
Netherlands Ep0214 1401 Zwolle
Poland Ep0214 1702 Bydgoszcz
Poland Ep0214 1701 Krakow
Spain Ep0214 1105 Barcelona
Spain Ep0214 1107 Barcelona
Spain Ep0214 1101 Mirasierra
Spain Ep0214 1102 Pamplona
Sweden Ep0214 502 Göteborg
United States Ep0214 117 Atlanta Georgia
United States Ep0214 103 Aurora Colorado
United States Ep0214 140 Bethesda Maryland
United States Ep0214 112 Boston Massachusetts
United States Ep0214 110 Chicago Illinois
United States Ep0214 131 Cleveland Ohio
United States Ep0214 146 Dallas Texas
United States Ep0214 126 Fort Worth Texas
United States Ep0214 136 Grand Rapids Michigan
United States Ep0214 115 Gulf Breeze Florida
United States Ep0214 105 Hackensack New Jersey
United States Ep0214 150 Hartsdale New York
United States Ep0214 118 Livingston New Jersey
United States Ep0214 144 Los Angeles California
United States Ep0214 104 Miami Florida
United States Ep0214 142 New York New York
United States Ep0214 121 Orlando Florida
United States Ep0214 141 Orlando Florida
United States Ep0214 120 Philadelphia Pennsylvania
United States Ep0214 143 Portland Oregon
United States Ep0214 109 Rochester Minnesota
United States Ep0214 147 Royal Oak Michigan
United States Ep0214 132 Saint Paul Minnesota
United States Ep0214 106 Salt Lake City Utah
United States Ep0214 145 San Antonio Texas
United States Ep0214 101 San Francisco California
United States Ep0214 125 Tacoma Washington
United States Ep0214 107 Tucson Arizona
United States Ep0214 149 Washington District of Columbia
United States Ep0214 139 York Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Denmark,  France,  Germany,  Italy,  Japan,  Mexico,  Netherlands,  Poland,  Spain,  Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Part 1: Change from baseline in frequency of seizures that result in drops in subjects receiving ZX008 compared to placebo Parent/caregiver seizure diary record will be used to assess frequency, type and duration of seizure activity Up to 20 weeks maintenance and taper period (T+M)
Secondary Part 2: Adverse events and related safety parameters in subjects receiving ZX008 compared to placebo Safety and tolerability evaluated by reported adverse events, laboratory parameters, physical and neurological examination, vital signs, electrocardiograms, echocardiograms, and body weight Up to 12 months open label
See also
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