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 144. レノックス・ガストー症候群 [臨床試験数:41,薬物数:43(DrugBank:10),標的遺伝子数:49,標的パスウェイ数:55] 

Searched query = "Lennox-Gastaut syndrome"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/20/2019, 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04133480December 9, 201928 October 2019Investigation of Cognitive Outcomes With Cannabidiol Oral SolutionAn Open-Label Exploratory Investigation of Cognitive Outcomes With Cannabidiol Oral Solution (EPIDIOLEX®; GWP42003-P)Lennox-Gastaut SyndromeDrug: GWP42003-PGW Research LtdNot recruiting3 Years10 YearsAll116Phase 4United States
2NCT04062981May 3, 20199 September 2019Carisbamate Safety Study in Adult and Pediatric Subjects With Lennox-Gastaut SyndromePhase 1, Open-Label Study of Carisbamate in Adult and Pediatric Subjects With Lennox-Gastaut SyndromeLennox Gastaut SyndromeDrug: CarisbamateSK Life Science, Inc.Recruiting2 YearsN/AAll30Phase 1United States
3NCT03936777April 22, 201924 June 2019A 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 SyndromeAn Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy for Seizures in Patients With Rare Seizure Disorders Such as Epileptic Encephalopathies Including Dravet Syndrome and Lennox-Gastaut SyndromeDravet Syndrome;Lennox Gastaut Syndrome;Epileptic EncephalopathyDrug: ZX008 (Fenfluramine Hydrochloride)Zogenix, Inc.Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.Recruiting2 YearsN/AAll650Phase 3United States
4NCT03731715February 7, 201926 August 2019Carisbamate in Adult & Pediatric Subjects With Lennox-Gastaut SyndromePhase I, Open-Label, Pharmacokinetic, Dose Escalation Study of Carisbamate in Adult and Pediatric Subjects With Lennox-Gastaut SyndromeLennox Gastaut SyndromeDrug: CarisbamateSK Life Science, Inc.Recruiting2 YearsN/AAll24Phase 1United States
5NCT03650452August 8, 20184 November 2019A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Patients With Developmental and/or Epileptic EncephalopathiesA Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 as an Adjunctive Therapy in Pediatric Patients With Developmental and/or Epileptic EncephalopathiesEpilepsy;Dravet Syndrome;Lennox-Gastaut SyndromeDrug: TAK-935;Drug: PlaceboTakedaOvid Therapeutics Inc.Recruiting2 Years17 YearsAll126Phase 2United States;Australia;Canada;China;Israel;Poland;Portugal;Spain
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2017-002628-26-BE23/07/201815 October 2018A 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 LGSA 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 LGSLennox-Gastaut Syndrome in Children and Adults
MedDRA version: 20.1 Level: PT Classification code 10048816 Term: Lennox-Gastaut syndrome System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: FENFLURAMINE HYDROCHLORIDE
Pharmaceutical Form: Oral solution
INN or Proposed INN: Fenfluramine
CAS Number: 404-82-0
Current Sponsor code: ZX008
Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: up to
Concentration number: 5-
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use
Zogenix International LimitedAuthorisedFemale: yes
Male: yes
225Phase 3United States;Finland;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden
7NCT03635073July 19, 201822 October 2019A Phase 2, Prospective, Interventional, Open-Label, Multi-Site, Extension Study to Assess the Long-Term Safety and Tolerability of TAK-935 (OV935) as Adjunctive Therapy in Patients With Rare EpilepsyA Phase 2, Prospective, Interventional, Open-Label, Multi-Site, Extension Study to Assess the Long-Term Safety and Tolerability of TAK-935 (OV935) as Adjunctive Therapy in Patients With Rare EpilepsyEpilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome, Dup15q Syndrome, CDKL5 Deficiency DisorderDrug: TAK-935TakedaOvid Therapeutics Inc.Recruiting2 Years65 YearsAll176Phase 2United States;Australia;China;Israel;Poland;Spain
8EUCTR2017-002628-26-ES12/06/201818 June 2018A 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 LGSA 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 LGSLennox-Gastaut Syndrome in Children and Adults
MedDRA version: 20.1 Level: PT Classification code 10048816 Term: Lennox-Gastaut syndrome System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: FENFLURAMINE HYDROCHLORIDE
Pharmaceutical Form: Oral solution
INN or Proposed INN: Fenfluramine
CAS Number: 404-82-0
Current Sponsor code: ZX008
Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: up to
Concentration number: 5-
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use
Zogenix International LimitedAuthorisedFemale: yes
Male: yes
225Phase 3United States;Finland;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden
9EUCTR2014-002321-35-BE05/06/201828 February 2019A global study completed at hospitals in US, Europe & Asia using an investigational drug (Perampanel) to research its safety & effectiveness in patients who are at least 2 years of age with Lennox-Gastaut SyndromeA Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial With an Open-Label Extension Phase of Perampanel as Adjunctive Treatment in Subjects at Least 2 years of Age With Inadequately Controlled Seizures Associated With Lennox-Gastaut SyndromeSeizures associated with Lennox-Gastaut Syndrome (LGS)
MedDRA version: 20.1 Level: PT Classification code 10048816 Term: Lennox-Gastaut syndrome System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Fycompa
Product Name: perampanel
Product Code: E2007
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: perampanel
CAS Number: 380917-97-5
Current Sponsor code: E2007
Other descriptive name: PERAMPANEL
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Trade Name: Fycompa
Product Name: perampanel
Product Code: E2007
Pharmaceutical Form: Oral suspension
INN or Proposed INN: Perampanel
CAS Number: 380917-97-5
Current Sponsor code: E2007
Other descriptive name: PERAMPANEL
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 0.5-
Pharmaceutical form of the placebo: Oral suspension
Route of administration of the placebo: Oral use
Eisai LimitedAuthorised Female: yes
Male: yes
142Phase 3Korea, Republic of;Italy;Japan;Latvia;Australia;Belgium;Poland;Canada;Czech Republic;Hungary;United States;France
10NCT03254680March 201811 June 2018Turmeric as Treatment in EpilepsyTurmeric as Treatment in EpilepsyEpilepsy;Dravet Syndrome;Lennox-Gastaut Syndrome;Tuberous Sclerosis;Focal SeizuresDietary Supplement: TurmericNew York University School of MedicineNot recruiting1 Year70 YearsAll0N/AUnited States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT03467113January 19, 201830 September 2019A Study to Assess the Safety and Tolerability of ZX008 in Children and Young Adults With DS or LGS Currently Taking CBDAn Open-Label Trial to Assess the Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Combination With Cannabidiol, as an Adjunctive Therapy in Children and Young Adults With Dravet Syndrome or Lennox-Gastaut SyndromeDravet Syndrome;Lennox Gastaut SyndromeDrug: ZX008 0.2 and 0.8 mg/kg/dayZogenix International Limited, Inc., a subsidiary of Zogenix, Inc.Not recruiting2 Years18 YearsAll25Phase 1/Phase 2United States
12NCT02318537December 30, 201718 January 2018Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Participants With Inadequately Controlled Lennox-Gastaut SyndromeA Multicenter, Randomized, Double-blind, Placebo-controlled, Interventional Study to Assess the Safety and Efficacy of Pharmaceutical Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Subjects With Inadequately Controlled Lennox-Gastaut SyndromeLennox-Gastaut SyndromeDrug: Cannabidiol Oral Solution;Drug: Placebo SolutionINSYS Therapeutics IncNot recruiting2 Years30 YearsAll0Phase 3
13NCT03355209November 27, 201730 September 2019A Study to Investigate the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) as an Adjunctive Therapy in Children and Adults With Lennox-Gastaut SyndromeA 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 LGSLennox Gastaut SyndromeDrug: ZX008 0.2 or 0.8 mg/kg/day;Drug: Matching PlaceboZogenix International Limited, Inc., a subsidiary of Zogenix, Inc.Recruiting2 Years35 YearsAll225Phase 3United States;Australia;Belgium;Canada;Denmark;France;Germany;Italy;Japan;Mexico;Netherlands;Poland;Spain;Sweden;Austria
14NCT02815540February 16, 201711 March 2019The Effects of Cannabidiol (CBD) on Electrical and Autonomic Cardiac Function in Children With Severe EpilepsyThe Effects of Cannabidiol (CBD) on Electrical and Autonomic Cardiac Function in ChildrenLennox-Gastaut Syndrome;Dravet SyndromeDrug: Cannabidiol;Procedure: 12-Lead ECGGillette Children's Specialty HealthcareNot recruiting2 Years30 YearsAll2Phase 1/Phase 2United States
15EUCTR2017-002628-26-DE7 January 2019A 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 LGSA 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 LGSLennox-Gastaut Syndrome in Children and Adults
MedDRA version: 20.1 Level: PT Classification code 10048816 Term: Lennox-Gastaut syndrome System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: FENFLURAMINE HYDROCHLORIDE
Pharmaceutical Form: Oral solution
INN or Proposed INN: Fenfluramine
CAS Number: 404-82-0
Current Sponsor code: ZX008
Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use
Product Name: FENFLURAMINE HYDROCHLORIDE
Pharmaceutical Form: Oral solution
INN or Proposed INN: Fenfluramine
CAS Number: 404-82-0
Current Sponsor code: ZX008
Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use
Product Name: FENFLURAMINE HYDROCHLORIDE
Pharmaceutical Form: Oral solution
INN or Proposed INN: Fenfluramine
CAS Number: 404-82-0
Current Sponsor code: ZX008
Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 1.25-
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use
Zogenix International Limited, a wholly owned subsidiary of Zogenix Inc.Not AvailableFemale: yes
Male: yes
225Phase 3United States;Finland;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2017-002628-26-IT17 September 2018A 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 LGSA 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 LGSLennox-Gastaut Syndrome in Children and Adults
MedDRA version: 20.1 Level: PT Classification code 10048816 Term: Lennox-Gastaut syndrome System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: FENFLURAMINE HYDROCHLORIDE
Pharmaceutical Form: Oral solution
INN or Proposed INN: Fenfluramine
CAS Number: 404-82-0
Current Sponsor code: ZX008
Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: up to
Concentration number: 5-
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use
Zogenix International Inc.Not AvailableFemale: yes
Male: yes
225Phase 3United States;Finland;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden
17EUCTR2017-002628-26-NL11 June 2018A 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 LGSA 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 LGSLennox-Gastaut Syndrome in Children and Adults
MedDRA version: 20.1 Level: PT Classification code 10048816 Term: Lennox-Gastaut syndrome System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: FENFLURAMINE HYDROCHLORIDE
Pharmaceutical Form: Oral solution
INN or Proposed INN: Fenfluramine
CAS Number: 404-82-0
Current Sponsor code: ZX008
Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: up to
Concentration number: 5-
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use
Zogenix International LimitedNot AvailableFemale: yes
Male: yes
225Phase 3United States;Finland;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Germany;Netherlands;Japan;Sweden
18JPRN-JapicCTI-17353613/12/201610 September 2019Study of Perampanel as Adjunctive Treatment for Inadequately Controlled Seizures Associated With Lennox-Gastaut SyndromeA Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial With an Open-Label Extension Phase of Perampanel as Adjunctive Treatment in Subjects at Least 2 years of Age With Inadequately Controlled Seizures Associated With Lennox-Gastaut SyndromeLennox-Gastaut Syndrome (LGS)Intervention name : E2007
INN of the intervention : Perampanel
Dosage And administration of the intervention : (1)subjects >=12 years of age: Perampanel oral tablets, 2 mg (2)subjects <12 years of age: Perampanel 0.5 milligrams per milliliter (mg/mL) oral suspension
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Matching-placebo
Eisai Co., Ltd.Recruiting2BOTH142Phase 3Japan, Asia except Japan, North America, Europe, Oceania
19NCT02834793December 13, 201628 October 2019Study of Perampanel as Adjunctive Treatment for Inadequately Controlled Seizures Associated With Lennox-Gastaut SyndromeA Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial With an Open-Label Extension Phase of Perampanel as Adjunctive Treatment in Subjects at Least 2 Years of Age With Inadequately Controlled Seizures Associated With Lennox-Gastaut SyndromeLennox-Gastaut Syndrome (LGS)Drug: Placebo;Drug: PerampanelEisai Inc.Recruiting2 YearsN/AAll142Phase 3United States;Australia;Belgium;Czechia;Japan;Korea, Republic of
20NCT02655198January 201611 February 2019Add-on Therapy With Low Dose Fenfluramine in Lennox Gastaut EpilepsyAdd-on Therapy With Low Dose Fenfluramine in Lennox Gastaut EpilepsyEpilepsy;Lennox Gastaut SyndromeDrug: FenfluramineKU LeuvenZogenix, Inc.Not recruiting3 Years18 YearsAll13Phase 2Belgium
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT02224560June 8, 201520 August 2018Efficacy and Safety of GWP42003-P for Seizures Associated With Lennox-Gastaut Syndrome in Children and AdultsA Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults.Epilepsy;Lennox Gastaut SyndromeDrug: GWP42003-P;Drug: Placebo controlGW Research LtdNot recruiting2 Years55 YearsAll225Phase 3United States;France;Spain;United Kingdom
22NCT02224573June 201517 June 2019GWPCARE5 - An Open Label Extension Study of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet or Lennox-Gastaut SyndromesAn Open Label Extension Study to Investigate the Safety of Cannabidiol (GWP42003-P; CBD) in Children and Young Adults With Inadequately Controlled Dravet or Lennox-Gastaut Syndromes.Epilepsy;Dravet Syndrome;Lennox-Gastaut SyndromeDrug: GWP42003-PGW Research LtdNot recruiting2 YearsN/AAll681Phase 3
23NCT02224690April 28, 201520 August 2018A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and AdultsA Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults.Epilepsy;Lennox-Gastaut SyndromeDrug: GWP42003-P 20 mg/kg/day Dose;Drug: PlaceboGW Research LtdNot recruiting2 Years55 YearsAll171Phase 3United States;Netherlands;Poland
24NCT02175173June 13, 201325 February 2019Post-marketing Surveillance of Long-term Administration of Inovelon Tablets in Patients With Lennox-Gastaut SyndromeLennox-Gastaut SyndromeDrug: RufinamideEisai Co., Ltd.RecruitingN/AN/AAll728Phase 3Japan
25JPRN-JapicCTI-13216929/5/201316 July 2019Post-marketing surveillance of long-term administration of Inovelon tablets in patients with Lennox-Gastaut syndromePost-marketing surveillance of long-term administration of Inovelon tablets in patients with Lennox-Gastaut syndromeLennox-Gastaut syndromeIntervention name : Rufinamide(Inovelon)
Dosage And administration of the intervention : Oral
Eisai Co., Ltd.RecruitingBOTH300NA
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT01668654September 4, 20122 July 2018Long-term, Open-label Safety Extension Study of Retigabine/Ezogabine in Pediatric Subjects (>= 12 Years Old) With POS or LGSRTG113388, 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)EpilepsyDrug: retigabine/ezogabineGlaxoSmithKlineValeant Pharmaceuticals International, Inc.Not recruiting12 Years29 YearsAll4Phase 3United States
27NCT01494584July 25, 20122 July 2018Study in Pediatric Subjects With EpilepsyOpen-label, Multiple Dose Study to Evaluate the Parmacokinetics, Safety and Tolerability of Ezogabine/Retigabine as Adjunctive Treatment in Subjects Aged From 12 Years to Less Than 18 Years With Partial Onset Seizures or Lennox-Gastaut SyndromeEpilepsyDrug: ezogabine/retigabineGlaxoSmithKlineValeant Pharmaceuticals International, Inc.Not recruiting12 Years17 YearsAll5Phase 2United States
28NCT01370486August 201119 February 2015Melatonin Versus Placebo in the Lennox-Gastaut Syndrome: Neurophysiological and Neuropsychological EffectsDouble Blind, Randomised, Cross-over Study Melatonin Versus Placebo in the Lennox-Gastaut Syndrome: Neurophysiological and Neuropsychological EffectsLennox-Gastaut SyndromeDrug: melatonin;Drug: placeboInstitution de LavignyNot recruiting18 Years55 YearsBoth6Phase 4Switzerland
29NCT01405053June 201111 April 2016Study of Rufinamide in Pediatric Subjects 1 to Less Than 4 Years of Age With Lennox-Gastaut Syndrome Inadequately Controlled With Other Anti-epileptic DrugsA Multicenter, Randomized, Controlled, Open-label Study to Evaluate the Cognitive Development Effects and Safety, and Pharmacokinetics of Adjunctive Rufinamide Treatment in Pediatric Subjects 1 to Less Than 4 Years of Age With Inadequately Controlled Lennox-Gastaut SyndromeLennox-Gastaut SyndromeDrug: Rufinamide;Drug: Any other approved AEDEisai Inc.Not recruiting1 Year3 YearsBoth37Phase 3United States;Canada;France;Greece;Italy;Poland;India;South Africa
30NCT01151540November 201019 February 2015A Long Term Extension Study of E2080 in Lennox-Gastaut PatientsA Long Term Extension Study of E2080 in Lennox-Gastaut PatientsLennox-Gastaut SyndromeDrug: E2080Eisai Co., Ltd.Not recruitingN/AN/ABoth54Phase 3Japan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
31NCT01146951June 201019 October 2017A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients (Study E2080-J081-304)A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome PatientsLennox-Gastaut SyndromeDrug: Rufinamide (E2080);Drug: PlaceboEisai LimitedNot recruiting4 Years30 YearsAll66Phase 3Japan
32EUCTR2010-020154-33-Outside-EU/EEA20 March 2012Long-term Open-label Evaluation of Retigabine in Pediatric Subjects with EpilepsyRTG113388, 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) - Long-term Open-label Safety Extension Study of Retigabine/Ezogabine in subjects >=12yrs with POS/LGSUncontrolled 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 Level: PT 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
Pharmaceutical Form: Tablet
INN or Proposed INN: RETIGABINE
CAS Number: 150812-12-7
Current Sponsor code: GW582892
Other descriptive name: EZOGABINE (US ONLY)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Trade Name: Potiga
Product Name: RETIGABINE/EZOGABINE
Product Code: GW582892
Pharmaceutical Form: Tablet
INN or Proposed INN: RETIGABINE
CAS Number: 150812-12-7
Current Sponsor code: GW582892
Other descriptive name: EZOGABINE (US ONLY)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
INN or Proposed INN: RETIGABINE
CAS Number: 150812-12-7
Current Sponsor code: GW582892
Other descriptive name: EZOGABINE (US ONLY)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
INN or Proposed INN: RETIGABINE
CAS Number: 150812-12-7
Current Sponsor code: GW582892
Other descriptive name: EZOGABINE (US ONLY)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
INN or Proposed INN: RETIGABINE
CAS Number: 150812-12-7
Current Sponsor code: GW52892
Other descriptive name: EZOGABINE (US only)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
Product Name: RETIGABINE/EZOGABINE
Product Code: GW582892
Pharmaceutical Form: Tablet
INN or Proposed INN: RETIGABINE
CAS Number: 150812-12-7
Current Sponsor code: GW582892
Other descriptive name: EZOGABINE (US ONLY)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
GlaxoSmithKline R&D LimitedNot AvailableFemale: yes
Male: yes
500United States
33EUCTR2010-023505-36-FR2 October 2017A controlled clinical trial to look at the effects of treatment with rufinamide on the body, thought process development and its safety in children aged 1 to 4 years with poorly controlled Lennox Gastaut Syndrome.A Multicenter, Randomized, Controlled, Open-label Study to Evaluate the Cognitive Development Effects and Safety, and Pharmacokinetics of Adjunctive Rufinamide Treatment in Pediatric Subjects 1 to less than 4 years of age with Inadequately Controlled Lennox-Gastaut SyndromeLennox Gastaut Syndrome
MedDRA version: 13.1 Level: PT Classification code 10048816 Term: Lennox-Gastaut syndrome System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: rufinamide oral suspension
Product Code: rufinamide oral suspension
Pharmaceutical Form: Oral suspension
INN or Proposed INN: RUFINAMIDE
CAS Number: 106308-44-5
Current Sponsor code: E2080
Other descriptive name: Rufinamide oral suspension
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 40-
Trade Name: Investigators choice of approved AEDs
Pharmaceutical Form:
INN or Proposed INN: Investigators Choice of Approved AED
CAS Number: N/A
Current Sponsor code: N/A
Other descriptive name: N/A
Eisai LtdNot AvailableFemale: yes
Male: yes
75Phase 3United States;France;Greece;Italy;India
34EUCTR2007-004322-24-LT17/03/200819 March 2012Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Clobazam (0.25, 0.5 and 1.0 mg/kg/day) in Patients with Lennox-Gastaut Syndrome.Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Clobazam (0.25, 0.5 and 1.0 mg/kg/day) in Patients with Lennox-Gastaut Syndrome.Lennox-Gastaut Syndrome
MedDRA version: 9.1 Level: LLT Classification code 10048816 Term: Lennox-Gastaut syndrome
Trade Name: Clobazam
Product Name: Clobazam Tablets 5mg
Pharmaceutical Form: Tablet
INN or Proposed INN: Clobazam
CAS Number: 22316-47-8
Other descriptive name: Clobazam PhEur
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Lundbeck IncNot RecruitingFemale: yes
Male: yes
240Bulgaria;Lithuania
35EUCTR2007-004350-82-LT17/03/200825 September 2012Safety and Effectiveness of Open-Label Clobazam in Subjects with Lennox Gastaut Syndrome -Lennox-Gastaut syndrome
MedDRA version: 9.1 Level: LLT Classification code 10048816 Term: Lennox-Gastaut syndrome
Trade Name: Clobazam
Product Name: Clobazam Tablets
Product Code: Clobazam Tablets 5mg
Pharmaceutical Form: Tablet
INN or Proposed INN: CLOBAZAM
CAS Number: 22316478
Other descriptive name: Clobazam PhEur
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Trade Name: Clobazam
Product Name: Clobazam Tablets
Product Code: Clobazam Tablets 10mg
Pharmaceutical Form: Tablet
INN or Proposed INN: Clobazam
CAS Number: 22316478
Other descriptive name: Clobazam PhEur
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Trade Name: Clobazam
Product Name: Clobazam Tablets
Product Code: Clobazam Tablets 20mg
Pharmaceutical Form: Tablet
INN or Proposed INN: Clobazam
CAS Number: 22316478
Other descriptive name: Clobazam Pheur
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Lundbeck IncNot RecruitingFemale: yes
Male: yes
304Bulgaria;Lithuania
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36NCT00518713August 200719 October 2017Clobazam in Patients With Lennox-Gastaut SyndromeDouble-Blind, Placebo-Controlled, Efficacy and Safety Study of Clobazam in Patients With Lennox-Gastaut SyndromeEpilepsy;Epilepsy, Generalized;SeizuresDrug: Clobazam Low Dose;Drug: Clobazam Medium Dose;Drug: Clobazam High Dose;Drug: PlaceboLundbeck LLCNot recruiting2 Years60 YearsAll238Phase 3United States;Australia;Belarus;India;Lithuania;Serbia
37NCT01160770December 200519 October 2017Safety and Effectiveness of Open-Label Clobazam in Subjects With Lennox-Gastaut SyndromeSafety and Effectiveness of Open-Label Clobazam in Subjects With Lennox-Gastaut SyndromeLennox-Gastaut SyndromeDrug: ClobazamLundbeck LLCNot recruiting2 Years60 YearsAll267Phase 3
38NCT00162981October 200519 October 2017Clobazam in Subjects With Lennox-Gastaut SyndromeSafety and Efficacy of Clobazam in Subjects With Lennox-Gastaut SyndromeEpilepsy;Epilepsy, Generalized;SeizuresDrug: Clobazam Low Dose;Drug: Clobazam High DoseLundbeck LLCNot recruiting2 Years30 YearsAll68Phase 2United States
39NCT00297349November 200319 February 2015A Study of the Safety of Topiramate Given in Combination With Other Medications in Adults and Children With SeizuresAn Open-label Observation Study of Topiramate Administration as Adjuvant Therapy for Focal Epilepsy, Lennox-Gastaut Syndrome Epileptic Seizures and Generalized Tonoclonic Seizures in Adults and Children Aged 2 Years and OlderSeizures;EpilepsyDrug: TopiramateJanssen Cilag Pharmaceutica S.A.C.I., GreeceNot recruiting2 YearsN/ABoth153N/A
40NCT00004776November 199319 February 2015Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Topiramate for Lennox-Gastaut SyndromeLennox-Gastaut SyndromeDrug: topiramateNational Center for Research Resources (NCRR)University of California, Los AngelesNot recruiting4 Years30 YearsBoth10Phase 3
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41NCT00236756August 199319 February 2015A Study of the Efficacy and Safety of Topiramate as an add-on Therapy in the Treatment of Epilepsy Patients With Lennox-Gastaut SyndromeA Double-Blind Trial of Topiramate in Subjects With Lennox-Gastaut Syndrome.Epilepsy;SeizuresDrug: topiramateJohnson & Johnson Pharmaceutical Research & Development, L.L.C.Not recruiting12 Months30 YearsBoth100Phase 3

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