Lennox Gastaut Syndrome Clinical Trial
Official title:
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
Verified date | April 2024 |
Source | UCB Pharma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. |
United States, Australia, Belgium, Canada, Denmark, France, Germany, Italy, Japan, Mexico, Netherlands, Poland, Spain, Sweden,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT02910297 -
The Pharmacokinetics of Cannabidiol (CBD) and Its Effects in Children With Severe Epilepsy
|
||
Recruiting |
NCT05339126 -
RNS System LGS Feasibility Study
|
Phase 2 | |
Completed |
NCT04062981 -
Carisbamate Safety Study in Adult and Pediatric Subjects With Lennox-Gastaut Syndrome
|
Phase 1 | |
Not yet recruiting |
NCT05066217 -
EPX-100 (Clemizole Hydrochloride) as Adjunctive Therapy in Children With Lennox Gastaut Syndrome
|
Phase 2 | |
Recruiting |
NCT04611438 -
Research on Cognitive Effect of Cannabidiol on Dravet Syndrome and Lennox-Gastaut SyndromeGastaut Syndrome
|
Phase 3 | |
Completed |
NCT05364021 -
Study to Investigate LP352 in Subjects With Developmental and Epileptic Encephalopathies
|
Phase 1/Phase 2 | |
Terminated |
NCT03955432 -
Long-term Cardiac Monitoring in Epilepsy
|
N/A | |
Completed |
NCT02224560 -
Efficacy and Safety of GWP42003-P for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults
|
Phase 3 | |
Not yet recruiting |
NCT06464653 -
Forel's Field Electrical Stimulation for Lennox-Gastaut Syndrome
|
N/A | |
Not yet recruiting |
NCT05485831 -
Epidyolex® in Lennox Gastaut and Dravet Syndrome: an Observational Study in ITALY
|
||
Active, not recruiting |
NCT05044819 -
Assessment of Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral Solution
|
Phase 4 | |
Not yet recruiting |
NCT05374824 -
Comparative Effectiveness of Palliative Surgery Versus Additional Anti-Seizure Medications for Lennox-Gastaut Syndrome
|
||
Active, not recruiting |
NCT02655198 -
Add-on Therapy With Low Dose Fenfluramine in Lennox Gastaut Epilepsy
|
Phase 2 | |
Completed |
NCT03467113 -
A Study to Assess the Safety and Tolerability of ZX008 in Children and Young Adults With Dravet Syndrome or Lennox Gastaut Syndrome Currently Taking Cannabidiol
|
Phase 1 | |
Completed |
NCT03731715 -
Carisbamate in Adult & Pediatric Subjects With Lennox-Gastaut Syndrome
|
Phase 1 | |
Recruiting |
NCT05219617 -
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
|
Phase 3 | |
Active, not recruiting |
NCT03936777 -
A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy Including Dravet Syndrome and Lennox-Gastaut Syndrome
|
Phase 3 | |
Available |
NCT03778424 -
An Extended Access Program (EAP) for Participants Who Have Completed Rufinamide Study E2080-G000-303
|
||
Available |
NCT02307578 -
An Extended Access Program (EAP) for Perampanel
|
||
Available |
NCT06149663 -
Intermediate-Size Expanded Access Protocol (EAP) for LP352
|