DDrare: Database of Drug Development for Rare Diseases

Searched query = "Lennox-Gastaut syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = Any other approved Antiepileptic Drug; CANNABIDIOL; CBD; CBD - Oral Solution, is known as Epidiolex, and is the approved name in the USA.; CLOBAZAM; Cannabidiol; Cannabidiol (CBD); Cannabidiol Oral Solution; Carisbamate; Clobazam; Clobazam High Dose; Clobazam Low Dose; Clobazam Medium Dose; Clobazam PhEur; Clobazam Pheur; Clobazam Tablets; Clobazam Tablets 10mg; Clobazam Tablets 20mg; Clobazam Tablets 5mg; E2007; E2080; EZOGABINE (US ONLY); EZOGABINE (US only); Ezogabine; Ezogabine/retigabine; FENFLURAMINE HYDROCHLORIDE; Fenfluramine; Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine; Fenfluramine hydrochloride (colorless); Fycompa; GW582892; GWP42003-P; GWP42003-P 20 mg/kg/day Dose; Inovelon; Investigators Choice of Approved AED; Investigators choice of approved AEDs; Lamictal; Lamotrigine; Melatonin; PERAMPANEL; Perampanel; Placebo; Potiga; Procedure: 12-Lead ECG; RETIGABINE; RETIGABINE/EZOGABINE; RUFINAMIDE; Retigabine; Retigabine/Ezogabine; Retigabine/ezogabine; Rufinamide; Rufinamide (E2080); Rufinamide oral suspension; Sodio valproato; TAK-935; Topimarate; Topimarato; Topiramate; Turmeric; ZX008; ZX008 (Fenfluramine Hydrochloride); ZX008 0.2 and 0.8 mg/kg/day; ZX008 0.2 or 0.8 mg/kg/day

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT03355209 (ClinicalTrials.gov)	November 27, 2017	19/6/2017	A Study to Investigate the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) as an Adjunctive Therapy in Children and Adults With Lennox-Gastaut Syndrome	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	Lennox Gastaut Syndrome	Drug: ZX008 0.2 or 0.8 mg/kg/day;Drug: Matching Placebo	Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.	NULL	Recruiting	2 Years	35 Years	All	225	Phase 3	United States;Australia;Belgium;Canada;Denmark;France;Germany;Italy;Japan;Mexico;Netherlands;Poland;Spain;Sweden;Austria

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agemin

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NCT03355209
(ClinicalTrials.gov)

November 27, 2017

19/6/2017

A Study to Investigate the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) as an Adjunctive Therapy in Children and Adults With Lennox-Gastaut Syndrome

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

Lennox Gastaut Syndrome

Drug: ZX008 0.2 or 0.8 mg/kg/day;Drug: Matching Placebo

Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.

NULL

Recruiting

2 Years

35 Years

All

225

Phase 3

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