DDrare: Database of Drug Development for Rare Diseases

144. レノックス・ガストー症候群
［臨床試験数：80，薬物数：63（DrugBank：11），標的遺伝子数：49，標的パスウェイ数：59］

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	NCT01668654 (ClinicalTrials.gov)	September 4, 2012	17/5/2012	Long-term, Open-label Safety Extension Study of Retigabine/Ezogabine in Pediatric Subjects (>= 12 Years Old) With POS or LGS	RTG113388, a Long-term, Open-label Safety Extension Study of Retigabine/Ezogabine in Pediatric Subjects With Partial Onset Seizures (>= 12 Years Old) and Subjects With Lennox-Gastaut Syndrome (>=12 Years Old)	Epilepsy	Drug: retigabine /ezogabine	GlaxoSmithKline	Bausch Health Americas, Inc.	Terminated	12 Years	29 Years	All	4	Phase 3	United States
2	EUCTR2012-001132-60-Outside-EU/EEA (EUCTR)		09/03/2012	Study in pediatric subjects with epilepsy	Open-label, multiple dose study to evaluate thepharmacokinetics, safety and tolerability of ezogabine/retigabineas adjunctive treatment in subjects aged from 12 years to lessthan 18 years with partial onset seizures or Lennox-Gastautsyndrome	Uncontrolled partial onset seizures or Lennox Gastaut Syndrome MedDRA version: 14.1;Level: PT;Classification code 10061334;Term: Partial seizures;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Potiga Product Name: Retigabine /Ezogabine Product Code: GW582892 INN or Proposed INN: RETIGABINE Other descriptive name: EZOGABINE (US ONLY) INN or Proposed INN: RETIGABINE Other descriptive name: EZOGABINE (US ONLY) INN or Proposed INN: RETIGABINE Other descriptive name: EZOGABINE (US ONLY) Product Name: Retigabine /Ezogabine INN or Proposed INN: RETIGABINE Other descriptive name: EZOGABINE (US ONLY) Product Name: Retigabine /Ezogabine INN or Proposed INN: RETIGABINE Other descriptive name: EZOGABINE (US ONLY)	GlaxoSmithKline R&D Limited	NULL	NA			Female: yes Male: yes	16		United States
3	EUCTR2010-020154-33-Outside-EU/EEA (EUCTR)		09/03/2012	Long-term Open-label Evaluation of Retigabine in Pediatric Subjects with Epilepsy	RTG113388, a Long-term, Open-label Safety Extension Study ofRetigabine/Ezogabine in Pediatric Subjects with Partial OnsetSeizures(=12 years old) and Subjects with Lennox-GastautSyndrome (=12 years old) - Long-term Open-label Safety Extension Study of Retigabine/Ezogabine in subjects >=12yrs with POS/LGS	Uncontrolled partial onset seizures or Lennox Gastaut Syndrome MedDRA version: 14.1;Level: PT;Classification code 10061334;Term: Partial seizures;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: RETIGABINE /EZOGABINE Product Code: GW582892 INN or Proposed INN: RETIGABINE Other descriptive name: EZOGABINE (US ONLY) Trade Name: Potiga Product Name: RETIGABINE /EZOGABINE Product Code: GW582892 INN or Proposed INN: RETIGABINE Other descriptive name: EZOGABINE (US ONLY) INN or Proposed INN: RETIGABINE Other descriptive name: EZOGABINE (US ONLY) INN or Proposed INN: RETIGABINE Other descriptive name: EZOGABINE (US ONLY) INN or Proposed INN: RETIGABINE Other descriptive name: EZOGABINE (US only) Product Name: RETIGABINE /EZOGABINE Product Code: GW582892 INN or Proposed INN: RETIGABINE Other descriptive name: EZOGABINE (US ONLY)	GlaxoSmithKline R&D Limited	NULL	NA			Female: yes Male: yes	500		United States

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

NCT01668654
(ClinicalTrials.gov)

September 4, 2012

17/5/2012

Long-term, Open-label Safety Extension Study of Retigabine/Ezogabine in Pediatric Subjects (>= 12 Years Old) With POS or LGS

RTG113388, a Long-term, Open-label Safety Extension Study of Retigabine/Ezogabine in Pediatric Subjects With Partial Onset Seizures (>= 12 Years Old) and Subjects With Lennox-Gastaut Syndrome (>=12 Years Old)

Epilepsy

Drug: retigabine /ezogabine

GlaxoSmithKline

Bausch Health Americas, Inc.

Terminated

12 Years

29 Years

All

Phase 3

United States

EUCTR2012-001132-60-Outside-EU/EEA
(EUCTR)

09/03/2012

Study in pediatric subjects with epilepsy

Open-label, multiple dose study to evaluate thepharmacokinetics, safety and tolerability of ezogabine/retigabineas adjunctive treatment in subjects aged from 12 years to lessthan 18 years with partial onset seizures or Lennox-Gastautsyndrome

Uncontrolled partial onset seizures or Lennox Gastaut Syndrome
MedDRA version: 14.1;Level: PT;Classification code 10061334;Term: Partial seizures;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 14.1;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Potiga
Product Name: Retigabine /Ezogabine
Product Code: GW582892
INN or Proposed INN: RETIGABINE
Other descriptive name: EZOGABINE (US ONLY)
INN or Proposed INN: RETIGABINE
Other descriptive name: EZOGABINE (US ONLY)
INN or Proposed INN: RETIGABINE
Other descriptive name: EZOGABINE (US ONLY)
Product Name: Retigabine /Ezogabine
INN or Proposed INN: RETIGABINE
Other descriptive name: EZOGABINE (US ONLY)
Product Name: Retigabine /Ezogabine
INN or Proposed INN: RETIGABINE
Other descriptive name: EZOGABINE (US ONLY)

GlaxoSmithKline R&D Limited

NULL

Female: yes
Male: yes

United States

EUCTR2010-020154-33-Outside-EU/EEA
(EUCTR)

09/03/2012

Long-term Open-label Evaluation of Retigabine in Pediatric Subjects with Epilepsy

RTG113388, a Long-term, Open-label Safety Extension Study ofRetigabine/Ezogabine in Pediatric Subjects with Partial OnsetSeizures(=12 years old) and Subjects with Lennox-GastautSyndrome (=12 years old) - Long-term Open-label Safety Extension Study of Retigabine/Ezogabine in subjects >=12yrs with POS/LGS

Product Name: RETIGABINE /EZOGABINE
Product Code: GW582892
INN or Proposed INN: RETIGABINE
Other descriptive name: EZOGABINE (US ONLY)
Trade Name: Potiga
Product Name: RETIGABINE /EZOGABINE
Product Code: GW582892
INN or Proposed INN: RETIGABINE
Other descriptive name: EZOGABINE (US ONLY)
INN or Proposed INN: RETIGABINE
Other descriptive name: EZOGABINE (US ONLY)
INN or Proposed INN: RETIGABINE
Other descriptive name: EZOGABINE (US ONLY)
INN or Proposed INN: RETIGABINE
Other descriptive name: EZOGABINE (US only)
Product Name: RETIGABINE /EZOGABINE
Product Code: GW582892
INN or Proposed INN: RETIGABINE
Other descriptive name: EZOGABINE (US ONLY)

GlaxoSmithKline R&D Limited

NULL

Female: yes
Male: yes

500

United States