A Two-Part Study of ZX008 in Children and Adults with Lennox-Gastaut Syndrome (LGS)

JRCT ID: jRCT2041200096

Registered date:29/01/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Lennox-Gastaut syndrome
• Date of first enrollment: 07/05/2019
• Target sample size: 300
• Countries of recruitment: Canda,Japan,US,Japan,Mexico,Japan,Belgium,Japan,Denmark,Japan,France,Japan,Germany,Japan,Italy,Japan,Netherland,Japan,Spain,Japan,Sweeden,Japan,Poland,Japan,Australia,Japan
• Study type: Interventional

Intervention(s)

ZX008 (Fenfluramine Hydrochloride) Oral Solution
0.2 - -.8 mg/kg. max 30mg/day

Outcome(s)

• Primary Outcome: The change in frequency of seizures that result in drops between baseline and the combined Titration and Maintenance Periods (T+M)

Key inclusion & exclusion criteria

• Age minimum: >= 2age old
• Age maximum: <= 35age old
• Gender: Both

Include criteria

- male or non-pregnant, non-lactating female, age 2 to 35 years,
- A diagnosis of Lennox-Gastaut syndrome, where seizures that result in drops are not completely controlled by current antiepileptic treatments.
- All of the following 4 criteria for Lennox-Gastaut syndrome
- Onset of seizures at 11 years of age or younger.
- Multiple seizure types (must include TS or TA), including countable motor seizures that result in drops. Countable motor seizure types eligible for inclusion are: GTC, TS, CS, AS, FS with observable motor symptoms, and MS with a drop.
- Abnormal cognitive development.
- Evidence of EEG in the medical history that shows abnormal background activity accompanied by slow spike and wave pattern less than 2.5 Hz.

Exclude criteria

-Etiology of seizures is a degenerative neurological disease.
-A history of hemiclonic seizures in the first year of life.
-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, or clinically significant structural cardiac abnormality, including but not limited to mitral valve prolapse, atrial or ventricular septal defects, patent ductus arteriosis.
-Current or recent history of Anorexia Nervosa, bulimia, or depression within the prior year that required medical treatment or psychological treatment for a duration greater than 1 month.
-A current or past history of glaucoma.

Related Information

• Primary Sponsor: YAMAMOTO Hideichiro