144. レノックス・ガストー症候群 Lennox-Gastaut syndrome Clinical trials / Disease details


臨床試験数 : 101 薬物数 : 68 - (DrugBank : 12) / 標的遺伝子数 : 49 - 標的パスウェイ数 : 60

  
No.TrialIDDate_
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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Recruitment_
Status
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agemin
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Inclusion_
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PhaseCountries
1EUCTR2021-002482-17-GR
(EUCTR)
17/03/202224/01/2022Open-Label Extension Study of Soticlestat in Dravet and Lennox-Gastaut SyndromesA Phase 3, Prospective, Open-Label, Multisite, Extension of Phase 3 Studies To Assess the Long-Term Safety and Tolerability of Soticlestat as Adjunctive Therapy in Subjects With Dravet Syndrome or Lennox-Gastaut Syndrome (ENDYMION 2). Dravet Syndrome (DS)Lennox-Gastaut Syndrome (LGS)
MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850
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: soticlestat
Product Code: TAK-935
INN or Proposed INN: SOTICLESTAT
Product Name: soticlestat
Product Code: TAK-935
INN or Proposed INN: SOTICLESTAT
Takeda Development Center Americas, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
376Phase 3United States;Serbia;Greece;Spain;Ukraine;Russian Federation;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Latvia;Netherlands;China;Japan
2NCT05163314
(ClinicalTrials.gov)
March 6, 202215/12/2021A Study of Soticlestat as an Add-on Therapy in Children and Adults With Dravet Syndrome or Lennox-Gastaut SyndromeA Phase 3, Prospective, Open-Label, Multisite, Extension of Phase 3 Studies To Assess the Long-Term Safety and Tolerability of Soticlestat as Adjunctive Therapy in Subjects With Dravet Syndrome or Lennox-Gastaut Syndrome (ENDYMION 2)Dravet Syndrome (DS);Lennox Gastaut Syndrome (LGS)Drug: SoticlestatTakedaNULLNot yet recruiting2 Years36 YearsAll376Phase 3United States;Australia;Belgium;Canada;China;France;Greece;Hungary;Italy;Japan;Latvia;Netherlands;Poland;Russian Federation;Serbia;Spain;Ukraine
3EUCTR2021-002481-40-BE
(EUCTR)
20/12/202112/08/2021Study of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut SyndromeA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome (LGS) 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]
Product Name: soticlestat
Product Code: TAK-935
INN or Proposed INN: soticlestat
Product Name: Soticlestat
Product Code: TAK-935
INN or Proposed INN: soticlestat
Takeda Development Center Americas, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
234Phase 3Japan;China;Latvia;Netherlands;Australia;Belgium;Poland;Canada;Hungary;France;Italy;United Kingdom;Russian Federation;Ukraine;Spain;Greece;United States;Serbia
4EUCTR2021-002481-40-NL
(EUCTR)
04/11/202109/08/2021Study of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut SyndromeA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome (LGS) 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]
Product Name: soticlestat
Product Code: TAK-935
INN or Proposed INN: soticlestat
Product Name: Soticlestat
Product Code: TAK-935
INN or Proposed INN: soticlestat
Takeda Development Center Americas, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
234Phase 3Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Latvia;Netherlands;China;Japan
5EUCTR2021-002481-40-HU
(EUCTR)
22/10/202125/10/2021Study of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut SyndromeA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome (LGS) 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]
Product Name: soticlestat
Product Code: TAK-935
INN or Proposed INN: soticlestat
Product Name: Soticlestat
Product Code: TAK-935
INN or Proposed INN: soticlestat
Takeda Development Center Americas, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
234Phase 3Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Latvia;China;Japan
6EUCTR2021-002481-40-PL
(EUCTR)
20/10/202117/09/2021Study of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut SyndromeA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome (LGS) 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]
Product Name: soticlestat
Product Code: TAK-935
INN or Proposed INN: soticlestat
Product Name: Soticlestat
Product Code: TAK-935
INN or Proposed INN: soticlestat
Takeda Development Center Americas, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
234Phase 3Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Latvia;China;Japan
7EUCTR2021-002481-40-IT
(EUCTR)
12/10/202127/07/2021Study of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut SyndromeA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome (LGS) - Skyway 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]
Product Name: soticlestat
Product Code: [TAK-935]
INN or Proposed INN: Soticlestat
Product Name: Soticlestat
Product Code: [TAK-935]
INN or Proposed INN: Soticlestat
TAKEDA DEVELOPMENT CENTER AMERICAS INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
234Phase 3Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Latvia;China;Japan
8EUCTR2021-002481-40-ES
(EUCTR)
05/10/202130/07/2021Study of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut SyndromeA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome (LGS) 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]
Product Name: soticlestat
Product Code: TAK-935
INN or Proposed INN: soticlestat
Product Name: Soticlestat
Product Code: TAK-935
INN or Proposed INN: soticlestat
Takeda Development Center Americas, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
234Phase 3Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Latvia;China;Japan
9NCT04938427
(ClinicalTrials.gov)
September 29, 202118/6/2021A Study of Soticlestat as an Add-on Therapy in Children, Teenagers, and Adults With Lennox-Gastaut SyndromeA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome (LGS)Lennox Gastaut Syndrome (LGS)Drug: Soticlestat;Drug: PlaceboTakedaNULLRecruiting2 Years35 YearsAll234Phase 3United States;Australia;Belgium;Canada;China;France;Greece;Hungary;Italy;Japan;Latvia;Netherlands;Poland;Russian Federation;Serbia;Spain;Ukraine
10JPRN-jRCT2051210073
29/09/202104/09/2021A Study of Soticlestat as an Add-on Therapy in Children, Teenagers, and Adults With Lennox-Gastaut SyndromeA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome (LGS) Lennox-Gastaut SyndromeSoticlestat
Participants weighing <45 kg: Soticlestat, mini-tablets, at the dose of 40 mg to 200 mg, orally or via gastrostomy tube (G-tube) or percutaneous endoscopic gastrostomy (PEG) tube, twice daily (BID) based on the body weight up to 4 weeks in Titration Period. Participants will continue to receive the dose that they are on at the end of the Titration Period, for 12 weeks in the Maintenance Period. Total duration of the treatment will be up to 16 weeks (Treatment Period). Dose will be tapered down if participants decide to discontinue the treatment.
Participants weighing >=45 kg: Soticlestat mini-tablets or tablets with a starting dose of 100 mg BID followed by 200 mg BID and, then 300 mg BID, up to 4 weeks in Titration Period. Participants will continue to receive 300 mg BID for 12 weeks in the Maintenance Period. Total duration of the treatment will be up to 16 weeks (Treatment Period). Dose will be tapered down if participants decide to discontinue the treatment.

Placebo
Soticlestat placebo-matching mini-tablets or tablets, orally or via G-tube or PEG tube, BID, up to 4 weeks in the Titration Period. Participants will continue to receive the soticlestat placebo-matching mini-tablets or tablets for 12 weeks in the Maintenance Period. The total duration of the treatment will be up to 16 weeks. Soticlestat matching tapering will be done to maintain the blind if participants decide to discontinue the treatment.
Nonomura HidenoriNULLRecruiting>= 2age old<= 35age oldBoth234Phase 3China,;Korea;Spain;Ukraine;United States;Russia;Serbia;Belgium;France;Greece;Hungary;Italy;Latvia;Poland,;Netherlands;United Kingdom;Australia;Canada;Japan
11EUCTR2021-002481-40-GR
(EUCTR)
22/09/202109/08/2021Study of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut SyndromeA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome (LGS) 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]
Product Name: soticlestat
Product Code: TAK-935
INN or Proposed INN: soticlestat
Product Name: Soticlestat
Product Code: TAK-935
INN or Proposed INN: soticlestat
Takeda Development Center Americas, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
234Phase 3Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Latvia;China;Japan
12NCT05044819
(ClinicalTrials.gov)
July 7, 202130/8/2021Assessment of Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral SolutionA Long-term Safety Study to Assess the Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral SolutionLennox Gastaut Syndrome;Dravet Syndrome;Tuberous Sclerosis ComplexDrug: CannabidiolGW Research LtdNULLRecruiting1 YearN/AAll150Phase 4United States
13NCT04133480
(ClinicalTrials.gov)
October 202017/10/2019Investigation 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 LtdNULLWithdrawn3 Years10 YearsAll0Phase 4United States
14EUCTR2019-001331-31-SE
(EUCTR)
17/06/202008/01/2020A 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 Syndrome Dravet syndrome or Lennox-Gastaut syndrome
MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Fenfluramine hydrochloride (colorless)
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
Other descriptive name: FENFLURAMINE HYDROCHLORIDE
Zogenix International LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
650Phase 3United States;Spain;Italy;United Kingdom;France;Mexico;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Japan;Sweden
15EUCTR2019-001331-31-DE
(EUCTR)
07/04/202013/11/2019A 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 Syndrome Dravet syndrome or Lennox-Gastaut syndrome
MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Fenfluramine hydrochloride (colorless)
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
Other descriptive name: FENFLURAMINE HYDROCHLORIDE
Zogenix International LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
650Phase 3United States;Spain;Italy;United Kingdom;France;Mexico;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Japan;Sweden
16NCT04611438
(ClinicalTrials.gov)
March 30, 202016/9/2019Research on Cognitive Effect of Cannabidiol on Dravet Syndrome and Lennox-Gastaut SyndromeGastaut SyndromeA Prospective Multi-Center Single-Arm Clinical Trial on Cognitive Effect of Cannabidiol (CBD-OS®) on Dravet Syndrome and Lennox-Gastaut SyndromeDravet Syndrome;Lennox Gastaut SyndromeDrug: CannabidiolYonsei UniversityNULLRecruiting2 Years18 YearsAll107Phase 3Korea, Republic of
17EUCTR2019-001331-31-NL
(EUCTR)
12/03/202004/02/2020A 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 Syndrome Dravet syndrome or Lennox-Gastaut syndrome
MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Fenfluramine hydrochloride (colorless)
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
Other descriptive name: FENFLURAMINE HYDROCHLORIDE
Zogenix International LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
650Phase 3United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Belgium;Poland;Australia;Denmark;Netherlands;Germany;Japan;Sweden
18EUCTR2019-001331-31-DK
(EUCTR)
17/01/202026/09/2019A 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 Syndrome Dravet syndrome or Lennox-Gastaut syndrome
MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Fenfluramine hydrochloride (colorless)
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
Other descriptive name: FENFLURAMINE HYDROCHLORIDE
Zogenix International LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
650Phase 3United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Belgium;Poland;Denmark;Australia;Germany;Netherlands;Japan;Sweden
19EUCTR2019-001331-31-IT
(EUCTR)
18/12/201917/06/2021A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With EpilepticEncephalopathy 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 forSeizures in Patients with Rare Seizure Disorders Such as Epileptic Encephalopathies Including Dravet Syndrome and Lennox-Gastaut Syndrome - - Dravet syndrome or Lennox-Gastaut syndrome
MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Fenfluramina cloridrato
Product Code: [ZX008]
INN or Proposed INN: Fenfluramina cloridrato
Other descriptive name: FENFLURAMINE HYDROCHLORIDE
Zogenix International LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
650Phase 3United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Japan;Sweden
20EUCTR2019-001331-31-FR
(EUCTR)
13/12/201916/10/2019A 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 Syndrome Dravet syndrome or Lennox-Gastaut syndrome
MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Fenfluramine hydrochloride (colorless)
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
Other descriptive name: FENFLURAMINE HYDROCHLORIDE
Zogenix International LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
650Phase 3Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Netherlands;United States;Spain;United Kingdom;Germany;Japan;Sweden
21EUCTR2019-001331-31-ES
(EUCTR)
10/12/201906/11/2019A 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 Syndrome Dravet syndrome or Lennox-Gastaut syndrome
MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Fenfluramine hydrochloride (colorless)
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
Other descriptive name: FENFLURAMINE HYDROCHLORIDE
Zogenix International LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
650 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Japan;Sweden
22EUCTR2019-001331-31-GB
(EUCTR)
07/11/201929/08/2019A 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 Syndrome Dravet syndrome or Lennox-Gastaut syndrome
MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Fenfluramine hydrochloride (colorless)
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
Other descriptive name: FENFLURAMINE HYDROCHLORIDE
Zogenix International LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
650Phase 3United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Japan;Sweden
23EUCTR2018-002485-39-PL
(EUCTR)
13/08/201907/05/2019A 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 DEVELOPMENTAL EPILEPTIC ENCEPHALOPATHIES INCLUDING DRAVET SYNDROME, LENNOX GASTAUT SYNDROME, CDKL5 DEFICIENCY DISORDER, AND CHROMOSOME 15 DUPLICATION SYNDROME (ENDYMION)A 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 DEVELOPMENTAL EPILEPTIC ENCEPHALOPATHIES INCLUDING DRAVET SYNDROME, LENNOX GASTAUT SYNDROME, CDKL5 DEFICIENCY DISORDER, AND CHROMOSOME 15 DUPLICATION SYNDROME (ENDYMION) developmental and epileptic encephalopathies;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: Soticlestat
Product Code: TAK-935
INN or Proposed INN: Soticlestat
Product Name: Soticlestat
Product Code: TAK-935
INN or Proposed INN: Soticlestat
Ovid Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
176Phase 2Portugal;United States;Canada;Spain;Poland;Australia;Israel;China
24JPRN-jRCT2041200096
07/05/201929/01/2021A Two-Part Study of ZX008 in Children and Adults with Lennox-Gastaut Syndrome (LGS)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 syndromeZX008 (Fenfluramine Hydrochloride) Oral Solution
0.2 - -.8 mg/kg. max 30mg/day
YAMAMOTO HideichiroNULLNot Recruiting>= 2age old<= 35age oldBoth300Phase 3Canda;US;Mexico;Belgium;Denmark;France;Germany;Italy;Netherland;Spain;Sweeden;Poland;Australia;Japan
25NCT04062981
(ClinicalTrials.gov)
May 3, 201930/5/2019Carisbamate 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.NULLRecruiting2 YearsN/AAll30Phase 1United States
26NCT03936777
(ClinicalTrials.gov)
April 22, 201912/4/2019A 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.Enrolling by invitation2 YearsN/AAll650Phase 3United States;Australia;Belgium;Canada;Denmark;France;Germany;Italy;Mexico;Netherlands;Poland;Spain;Sweden;United Kingdom
27NCT03731715
(ClinicalTrials.gov)
February 7, 201916/10/2018Carisbamate 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.NULLRecruiting2 YearsN/AAll24Phase 1United States
28EUCTR2017-002628-26-SE
(EUCTR)
21/01/201929/05/2018A Two-Part Study of ZX008 in Children and Adults withLennox-Gastaut Syndrome (LGS); Part 1: A Randomized,Double-blind, Placebo-controlled Trial of Two Fixed Dosesof ZX008 (Fenfluramine Hydrochloride) Oral Solution asAdjunctive Therapy for Seizures in Children and Adults withLGS, Followed by Part 2: An Open-label Extension toAssess Long-Term Safety of ZX008 in Children and Adultswith LGSA Two-Part Study of ZX008 in Children and Adults withLennox-Gastaut Syndrome (LGS); Part 1: A Randomized,Double-blind, Placebo-controlled Trial of Two Fixed Dosesof ZX008 (Fenfluramine Hydrochloride) Oral Solution asAdjunctive Therapy for Seizures in Children and Adults withLGS, Followed by Part 2: An Open-label Extension toAssess Long-Term Safety of ZX008 in Children and Adultswith LGS Lennox-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
INN or Proposed INN: Fenfluramine
Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine
Product Name: FENFLURAMINE HYDROCHLORIDE
INN or Proposed INN: Fenfluramine
Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine
Product Name: FENFLURAMINE HYDROCHLORIDE
INN or Proposed INN: Fenfluramine
Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine
Zogenix International Limited, a wholly owned subsidiary of Zogenix Inc.NULLNot RecruitingFemale: yes
Male: yes
250Phase 3United States;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden
29NCT03778424
(ClinicalTrials.gov)
January 9, 201927/11/2018An Extended Access Program (EAP) for Participants Who Have Completed Rufinamide Study E2080-G000-303An Extended Access Program (EAP) for Rufinamide in Pediatric Participants With Inadequately Controlled Lennox-Gastaut SyndromeLennox Gastaut SyndromeDrug: RufinamideEisai Inc.NULLAvailable4 YearsN/AAllPoland
30EUCTR2017-002628-26-DE
(EUCTR)
15/11/201811/04/2018A Two-Part Study of ZX008 in Children and Adults withLennox-Gastaut Syndrome (LGS); Part 1: A Randomized,Double-blind, Placebo-controlled Trial of Two Fixed Dosesof ZX008 (Fenfluramine Hydrochloride) Oral Solution asAdjunctive Therapy for Seizures in Children and Adults withLGS, Followed by Part 2: An Open-label Extension toAssess Long-Term Safety of ZX008 in Children and Adultswith LGSA Two-Part Study of ZX008 in Children and Adults withLennox-Gastaut Syndrome (LGS); Part 1: A Randomized,Double-blind, Placebo-controlled Trial of Two Fixed Dosesof ZX008 (Fenfluramine Hydrochloride) Oral Solution asAdjunctive Therapy for Seizures in Children and Adults withLGS, Followed by Part 2: An Open-label Extension toAssess Long-Term Safety of ZX008 in Children and Adultswith LGS Lennox-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
INN or Proposed INN: Fenfluramine
Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine
Product Name: FENFLURAMINE HYDROCHLORIDE
INN or Proposed INN: Fenfluramine
Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine
Product Name: FENFLURAMINE HYDROCHLORIDE
INN or Proposed INN: Fenfluramine
Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine
Zogenix International Limited, a wholly owned subsidiary of Zogenix Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3United States;Finland;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Japan;Sweden
31EUCTR2017-002628-26-FR
(EUCTR)
09/11/201814/08/2018 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 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 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
INN or Proposed INN: Fenfluramine
Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine
Product Name: FENFLURAMINE HYDROCHLORIDE
INN or Proposed INN: Fenfluramine
Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine
Product Name: FENFLURAMINE HYDROCHLORIDE
INN or Proposed INN: Fenfluramine
Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine
Zogenix International Limited, a wholly owned subsidiary of Zogenix Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
225 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Finland;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden
32EUCTR2017-002628-26-NL
(EUCTR)
24/09/201806/06/2018A Two-Part Study of ZX008 in Children and Adults withLennox-Gastaut Syndrome (LGS); Part 1: A Randomized,Double-blind, Placebo-controlled Trial of Two Fixed Dosesof ZX008 (Fenfluramine Hydrochloride) Oral Solution asAdjunctive Therapy for Seizures in Children and Adults withLGS, Followed by Part 2: An Open-label Extension toAssess Long-Term Safety of ZX008 in Children and Adultswith LGSA Two-Part Study of ZX008 in Children and Adults withLennox-Gastaut Syndrome (LGS); Part 1: A Randomized,Double-blind, Placebo-controlled Trial of Two Fixed Dosesof ZX008 (Fenfluramine Hydrochloride) Oral Solution asAdjunctive Therapy for Seizures in Children and Adults withLGS, Followed by Part 2: An Open-label Extension toAssess Long-Term Safety of ZX008 in Children and Adultswith LGS Lennox-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
INN or Proposed INN: Fenfluramine
Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine
Product Name: FENFLURAMINE HYDROCHLORIDE
INN or Proposed INN: Fenfluramine
Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine
Product Name: FENFLURAMINE HYDROCHLORIDE
INN or Proposed INN: Fenfluramine
Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine
Zogenix International Limited, a wholly owned subsidiary of Zogenix Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
225Phase 3United States;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden
33NCT03650452
(ClinicalTrials.gov)
August 8, 201827/8/2018A 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 Participants 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 (OV935) as an Adjunctive Therapy in Pediatric Patients With Developmental and/or Epileptic EncephalopathiesEpilepsy;Dravet Syndrome;Lennox-Gastaut SyndromeDrug: TAK-935;Drug: PlaceboTakedaOvid Therapeutics Inc.Completed2 Years17 YearsAll141Phase 2United States;Australia;Canada;China;Israel;Poland;Portugal;Spain
34EUCTR2017-002628-26-BE
(EUCTR)
23/07/201830/03/2018A Two-Part Study of ZX008 in Children and Adults withLennox-Gastaut Syndrome (LGS); Part 1: A Randomized,Double-blind, Placebo-controlled Trial of Two Fixed Dosesof ZX008 (Fenfluramine Hydrochloride) Oral Solution asAdjunctive Therapy for Seizures in Children and Adults withLGS, Followed by Part 2: An Open-label Extension toAssess Long-Term Safety of ZX008 in Children and Adultswith LGSA Two-Part Study of ZX008 in Children and Adults withLennox-Gastaut Syndrome (LGS); Part 1: A Randomized,Double-blind, Placebo-controlled Trial of Two Fixed Dosesof ZX008 (Fenfluramine Hydrochloride) Oral Solution asAdjunctive Therapy for Seizures in Children and Adults withLGS, Followed by Part 2: An Open-label Extension toAssess Long-Term Safety of ZX008 in Children and Adultswith LGS Lennox-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
INN or Proposed INN: Fenfluramine
Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine
Product Name: FENFLURAMINE HYDROCHLORIDE
INN or Proposed INN: Fenfluramine
Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine
Product Name: FENFLURAMINE HYDROCHLORIDE
INN or Proposed INN: Fenfluramine
Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine
Zogenix International Limited, a wholly owned subsidiary of Zogenix Inc.NULLNot RecruitingFemale: yes
Male: yes
250Phase 3United States;Finland;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden
35NCT03635073
(ClinicalTrials.gov)
July 19, 20186/8/2018A Study of Soticlestat in Adults and Children With Rare EpilepsiesA Phase 2, Prospective, Interventional, Open-Label, Multi-Site, Extension Study to Assess the Long-Term Safety and Tolerability of Soticlestat (TAK-935) as Adjunctive Therapy in Subjects With Developmental Epileptic Encephalopathies Including Dravet Syndrome, Lennox Gastaut Syndrome, CDKL5 Deficiency Disorder, and Chromosome 15 Duplication Syndrome (ENDYMION 1)Epilepsy;Dravet Syndrome (DS);Lennox-Gastaut Syndrome (LGS)Drug: SoticlestatTakedaNULLActive, not recruiting2 YearsN/AAll156Phase 2United States;Australia;Canada;China;Israel;Poland;Portugal;Spain
36EUCTR2017-002628-26-IT
(EUCTR)
16/07/201825/05/2018 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 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 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
INN or Proposed INN: Fenfluramine
Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine
Zogenix International Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
225 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Finland;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden
37EUCTR2017-002628-26-DK
(EUCTR)
09/07/201817/05/2018A Two-Part Study of ZX008 in Children and Adults withLennox-Gastaut Syndrome (LGS); Part 1: A Randomized,Double-blind, Placebo-controlled Trial of Two Fixed Dosesof ZX008 (Fenfluramine Hydrochloride) Oral Solution asAdjunctive Therapy for Seizures in Children and Adults withLGS, Followed by Part 2: An Open-label Extension toAssess Long-Term Safety of ZX008 in Children and Adultswith LGSA Two-Part Study of ZX008 in Children and Adults withLennox-Gastaut Syndrome (LGS); Part 1: A Randomized,Double-blind, Placebo-controlled Trial of Two Fixed Dosesof ZX008 (Fenfluramine Hydrochloride) Oral Solution asAdjunctive Therapy for Seizures in Children and Adults withLGS, Followed by Part 2: An Open-label Extension toAssess Long-Term Safety of ZX008 in Children and Adultswith LGS Lennox-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
INN or Proposed INN: Fenfluramine
Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine
Product Name: FENFLURAMINE HYDROCHLORIDE
INN or Proposed INN: Fenfluramine
Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine
Product Name: FENFLURAMINE HYDROCHLORIDE
INN or Proposed INN: Fenfluramine
Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine
Zogenix International Limited, a wholly owned subsidiary of Zogenix Inc.NULLNot RecruitingFemale: yes
Male: yes
250Phase 3Sweden;Japan;Netherlands;Germany;Norway;Australia;Denmark;Belgium;Poland;Canada;Mexico;France;Italy;United Kingdom;Israel;Austria;Spain;United States
38EUCTR2017-002628-26-ES
(EUCTR)
12/06/201820/04/2018A 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 LGS Lennox-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
INN or Proposed INN: Fenfluramine
Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine
Zogenix International LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: 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
39EUCTR2014-002321-35-BE
(EUCTR)
05/06/201825/04/2017A 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 Syndrome Seizures 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
INN or Proposed INN: perampanel
Other descriptive name: PERAMPANEL
Trade Name: Fycompa
Product Name: perampanel
Product Code: E2007
INN or Proposed INN: Perampanel
Other descriptive name: PERAMPANEL
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
142Phase 3United States;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Latvia;Japan;Italy;Korea, Republic of
40NCT03254680
(ClinicalTrials.gov)
March 201815/8/2017Turmeric as Treatment in EpilepsyTurmeric as Treatment in EpilepsyEpilepsy;Dravet Syndrome;Lennox-Gastaut Syndrome;Tuberous Sclerosis;Focal SeizuresDietary Supplement: TurmericNYU Langone HealthNULLWithdrawn1 Year70 YearsAll0N/AUnited States
41NCT03467113
(ClinicalTrials.gov)
January 19, 201830/1/2018A Study to Assess the Safety and Tolerability of ZX008 in Children and Young Adults With Dravet Syndrome or Lennox Gastaut Syndrome Currently Taking CannabidiolAn 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 to 0.8 mg/kg/day;Drug: CannabidiolZogenix International Limited, Inc., a subsidiary of Zogenix, Inc.NULLCompleted2 Years18 YearsAll9Phase 1/Phase 2United States
42NCT02318537
(ClinicalTrials.gov)
December 30, 201712/12/2014Cannabidiol 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 IncNULLWithdrawn2 Years30 YearsAll0Phase 3NULL
43NCT03355209
(ClinicalTrials.gov)
November 27, 201719/6/2017A 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.NULLActive, not recruiting2 Years35 YearsAll296Phase 3United States;Australia;Belgium;Canada;Denmark;France;Germany;Italy;Japan;Mexico;Netherlands;Poland;Spain;Sweden;Austria
44EUCTR2014-002321-35-IT
(EUCTR)
01/09/201720/01/2022A global study completed at hospitals in US, Europe & Asia using an investigational drug (Perampanel) to research its safety & effectiveness inpatients who are at least 2 years of age with Lennox-Gastaut SyndromeA Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial With anOpen-Label Extension Phase of Perampanel as Adjunctive Treatment inSubjects at Least 2 years of Age With Inadequately Controlled SeizuresAssociated With Lennox-Gastaut Syndrome - - Seizures 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
INN or Proposed INN: PERAMPANEL
Other descriptive name: PERAMPANEL
Trade Name: Fycompa
INN or Proposed INN: PERAMPANEL
Other descriptive name: PERAMPANEL
EISAI LIMITEDNULLNot RecruitingFemale: yes
Male: yes
142Phase 3United States;Czechia;Korea, Democratic People's Republic of;Lithuania;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Latvia;Japan;Korea, Republic of
45EUCTR2014-002321-35-CZ
(EUCTR)
31/08/201726/05/2017A 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 Syndrome Seizures 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
INN or Proposed INN: perampanel
Other descriptive name: PERAMPANEL
Trade Name: Fycompa
Product Name: perampanel
Product Code: E2007
INN or Proposed INN: Perampanel
Other descriptive name: PERAMPANEL
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
142Phase 3United States;Czechia;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Latvia;Japan;Korea, Republic of
46EUCTR2014-002321-35-LV
(EUCTR)
26/05/201709/05/2017A 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 Syndrome Seizures associated with Lennox-Gastaut Syndrome (LGS)
MedDRA version: 20.0;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
INN or Proposed INN: perampanel
Other descriptive name: PERAMPANEL
Trade Name: Fycompa
Product Name: perampanel
Product Code: E2007
INN or Proposed INN: Perampanel
Other descriptive name: PERAMPANEL
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
142Phase 3France;United States;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Latvia;Japan;Italy;Korea, Republic of
47EUCTR2014-002321-35-HU
(EUCTR)
08/05/201720/04/2017A 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 Syndrome Seizures associated with Lennox-Gastaut Syndrome (LGS)
MedDRA version: 19.1;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
INN or Proposed INN: perampanel
Other descriptive name: PERAMPANEL
Trade Name: Fycompa
Product Name: perampanel
Product Code: E2007
INN or Proposed INN: Perampanel
Other descriptive name: PERAMPANEL
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
142Phase 3United States;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Latvia;Japan;Italy;Korea, Republic of
48NCT02815540
(ClinicalTrials.gov)
February 16, 201720/6/2016The 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 SyndromeProcedure: 12-Lead ECG;Drug: CannabidiolGillette Children's Specialty HealthcareNULLTerminated2 Years30 YearsAll2Phase 1/Phase 2United States
49NCT02834793
(ClinicalTrials.gov)
December 13, 201613/7/2016Study 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.NULLTerminated2 YearsN/AAll70Phase 3Czechia;India;Japan;Korea, Republic of;Australia;Belgium;United States;Austria
50JPRN-JapicCTI-173536
13/12/201615/03/2017Study 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 Syndrome Lennox-Gastaut Syndrome (LGS)Intervention name : E2007
INN of the intervention : Perampanel
Dosage And administration of the intervention : 2 mg oral tablets and 0.5 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.NULLcomplete2BOTH142Phase 3Japan, Asia except Japan, North America, Europe, Oceania
51NCT02655198
(ClinicalTrials.gov)
January 201612/1/2016Add-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.Active, not recruiting3 Years18 YearsAll13Phase 2Belgium
52EUCTR2014-002941-23-NL
(EUCTR)
30/09/201531/03/2015Study 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 Lennox-Gastaut syndrome
MedDRA version: 19.0;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: Cannabidiol (CBD)
Product Code: GWP42003-P
INN or Proposed INN: N/A
Other descriptive name: CANNABIDIOL
GW Research Ltd.NULLNot RecruitingFemale: yes
Male: yes
100United States;Poland;Netherlands
53EUCTR2014-001834-27-NL
(EUCTR)
09/09/201518/06/2015An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut SyndromesAn open label extension study to investigate the safety of cannabidiol (GWP42003-P; CBD) in children and adults with inadequately controlled Dravet or Lennox-Gastaut Syndromes Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS)
MedDRA version: 20.0;Level: PT;Classification code 10073677;Term: Severe myoclonic epilepsy of infancy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: CBD - Oral Solution, is known as Epidiolex, and is the approved name in the USA.
Product Name: Cannabidiol (CBD)
Product Code: GWP42003-P
INN or Proposed INN: N/A
Other descriptive name: CANNABIDIOL
GW Research LtdNULLNot RecruitingFemale: yes
Male: yes
680Phase 3United States;France;Spain;Poland;Australia;Israel;Netherlands;United Kingdom
54EUCTR2014-001834-27-FR
(EUCTR)
03/09/201520/07/2015An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut SyndromesAn open label extension study to investigate the safety of cannabidiol (GWP42003-P; CBD) in children and adults with inadequately controlled Dravet or Lennox-Gastaut Syndromes Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS)
MedDRA version: 18.0;Level: PT;Classification code 10073677;Term: Severe myoclonic epilepsy of infancy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cannabidiol (CBD)
Product Code: GWP42003-P
INN or Proposed INN: N/A
Other descriptive name: CANNABIDIOL
GW Research LtdNULLNot RecruitingFemale: yes
Male: yes
530Phase 3United States;France;Spain;Poland;Israel;Netherlands;United Kingdom
55EUCTR2014-001834-27-PL
(EUCTR)
18/08/201514/05/2015An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut SyndromesAn open label extension study to investigate the safety of cannabidiol (GWP42003-P; CBD) in children and adults with inadequately controlled Dravet or Lennox-Gastaut Syndromes Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS)
MedDRA version: 20.0;Level: PT;Classification code 10073677;Term: Severe myoclonic epilepsy of infancy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: CBD - Oral Solution, is known as Epidiolex, and is the approved name in the USA.
Product Name: Cannabidiol (CBD)
Product Code: GWP42003-P
INN or Proposed INN: N/A
Other descriptive name: CANNABIDIOL
GW Research LtdNULLNot RecruitingFemale: yes
Male: yes
680Phase 3United States;France;Spain;Poland;Australia;Israel;Netherlands;United Kingdom
56NCT02307578
(ClinicalTrials.gov)
August 20152/12/2014An Extended Access Program (EAP) for PerampanelAn Extended Access Program (EAP) for PerampanelPrimary Generalized Tonic-Clonic or Partial Onset Seizures;Lennox Gastaut SyndromeDrug: PerampanelEisai Inc.NULLAvailable1 YearN/AAllPoland;Spain;Belgium;Chile;Estonia;Hungary;Latvia;Lithuania
57EUCTR2014-002940-42-GB
(EUCTR)
28/07/201526/09/2014A 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. Lennox-Gastaut syndrome (LGS)
MedDRA version: 18.0;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: Cannabidiol (CBD)
Product Code: GWP42003-P
INN or Proposed INN: N/A
Other descriptive name: CANNABIDIOL
GW Research LtdNULLNot RecruitingFemale: yes
Male: yes
150Phase 3France;United States;Spain;United Kingdom
58EUCTR2014-002941-23-PL
(EUCTR)
16/07/201501/04/2015Study 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 toinvestigate the efficacy and safety of cannabidiol (GWP42003-P;CBD) as adjunctive treatment for seizures associated with Lennox-Gastaut syndrome in children and adults Lennox-Gastaut syndrome
MedDRA version: 18.1;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: Cannabidiol (CBD)
Product Code: GWP42003-P
INN or Proposed INN: N/A
Other descriptive name: CANNABIDIOL
GW Research Ltd.NULLNot RecruitingFemale: yes
Male: yes
100Phase 3United States;Poland;Netherlands
59NCT02224560
(ClinicalTrials.gov)
June 8, 201521/8/2014Efficacy 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 LtdNULLCompleted2 Years55 YearsAll225Phase 3United States;France;Spain;United Kingdom
60NCT02224573
(ClinicalTrials.gov)
June 201521/8/2014GWPCARE5 - 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 LtdNULLCompleted2 YearsN/AAll681Phase 3NULL
61EUCTR2014-001834-27-ES
(EUCTR)
21/05/201514/04/2015An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut SyndromesAn open label extension study to investigate the safety of cannabidiol (GWP42003-P; CBD) in children and adults with inadequately controlled Dravet or Lennox-Gastaut Syndromes Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS)
MedDRA version: 18.0;Level: PT;Classification code 10073677;Term: Severe myoclonic epilepsy of infancy;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cannabidiol (CBD)
Product Code: GWP42003-P
INN or Proposed INN: N/A
Other descriptive name: CANNABIDIOL
GW Research LtdNULLNot Recruiting Female: yes
Male: yes
430 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Poland;Spain;Israel;Netherlands;United Kingdom
62NCT02224690
(ClinicalTrials.gov)
April 28, 201521/8/2014A 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 LtdNULLCompleted2 Years55 YearsAll171Phase 3United States;Netherlands;Poland
63EUCTR2014-002940-42-ES
(EUCTR)
08/04/201516/12/2014A 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. Lennox-Gastaut syndrome (LGS)
MedDRA version: 17.1;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: Cannabidiol (CBD)
Product Code: GWP42003-P
INN or Proposed INN: N/A
Other descriptive name: CANNABIDIOL
GW Research LtdNULLNot RecruitingFemale: yes
Male: yes
120Phase 3France;United States;Spain;United Kingdom
64EUCTR2014-001834-27-GB
(EUCTR)
14/01/201530/09/2014An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut SyndromesAn open label extension study to investigate the safety of cannabidiol (GWP42003-P; CBD) in children and adults with inadequately controlled Dravet or Lennox-Gastaut Syndromes Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS)
MedDRA version: 20.0;Level: PT;Classification code 10073677;Term: Severe myoclonic epilepsy of infancy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cannabidiol (CBD)
Product Code: GWP42003-P
INN or Proposed INN: N/A
Other descriptive name: CANNABIDIOL
GW Research LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
680Phase 3France;United States;Poland;Spain;Australia;Israel;Netherlands;United Kingdom
65NCT02175173
(ClinicalTrials.gov)
June 13, 201310/6/2014Post-marketing Surveillance of Long-term Administration of Inovelon Tablets in Patients With Lennox-Gastaut SyndromeLennox-Gastaut SyndromeDrug: RufinamideEisai Co., Ltd.NULLRecruitingN/AN/AAll728Japan
66JPRN-JapicCTI-132169
29/5/201321/06/2013Post-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 syndrome Lennox-Gastaut syndromeIntervention name : Inovelon
INN of the intervention : Rufinamide
Dosage And administration of the intervention : Oral
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Eisai Co., Ltd.NULLrecruitingBOTH300NAJapan
67NCT01668654
(ClinicalTrials.gov)
September 4, 201217/5/2012Long-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/ezogabineGlaxoSmithKlineBausch Health Americas, Inc.Terminated12 Years29 YearsAll4Phase 3United States
68EUCTR2010-023505-36-GR
(EUCTR)
08/08/201208/08/2012A 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 ControlledLennox-Gastaut Syndrome Lennox Gastaut Syndrome
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: rufinamide oral suspension
Product Code: rufinamide oral suspension
INN or Proposed INN: RUFINAMIDE
Other descriptive name: Rufinamide oral suspension
Trade Name: Investigators choice of approved AEDs
INN or Proposed INN: Investigators Choice of Approved AED
Other descriptive name: N/A
Eisai LtdNULLNot RecruitingFemale: yes
Male: yes
75United States;Greece;South Africa;Italy
69NCT01494584
(ClinicalTrials.gov)
July 25, 20121/12/2011Study 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/retigabineGlaxoSmithKlineBausch Health Americas, Inc.Terminated12 Years17 YearsAll5Phase 2United States
70EUCTR2010-023505-36-IT
(EUCTR)
29/09/201105/01/2012A 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 SyndromeA 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 Syndrome - E2080-G000-303 Lennox Gastaut Syndrome
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]
Trade Name: Inovelon
Other descriptive name: Rufinamide oral suspension
INN or Proposed INN: lamotrigine
Other descriptive name: Lamictal
INN or Proposed INN: sodio valproato
INN or Proposed INN: topimarato
Other descriptive name: topimarate
EISAI LTD UKNULLNot RecruitingFemale: yes
Male: yes
75Greece;Italy
71NCT01370486
(ClinicalTrials.gov)
August 20118/6/2011Melatonin 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 LavignyNULLNot yet recruiting18 Years55 YearsBoth6Phase 4Switzerland
72NCT01405053
(ClinicalTrials.gov)
June 16, 201127/7/2011Study 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 Antiepileptic DrugEisai Inc.NULLCompleted1 Year3 YearsAll37Phase 3United States;Canada;France;Greece;Italy;Poland;South Africa;India
73NCT01151540
(ClinicalTrials.gov)
November 201014/6/2010A Long Term Extension Study of E2080 in Lennox-Gastaut PatientsA Long Term Extension Study of E2080 in Lennox-Gastaut PatientsLennox-Gastaut SyndromeDrug: RufinamideEisai Co., Ltd.NULLCompleted4 Years30 YearsAll54Phase 3Japan
74NCT01146951
(ClinicalTrials.gov)
June 201014/6/2010A 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 LimitedNULLCompleted4 Years30 YearsAll66Phase 3Japan
75EUCTR2007-004350-82-BG
(EUCTR)
10/11/200813/11/2008Safety 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
INN or Proposed INN: CLOBAZAM
Other descriptive name: Clobazam PhEur
Trade Name: Clobazam
Product Name: Clobazam Tablets
Product Code: Clobazam Tablets 10mg
INN or Proposed INN: Clobazam
Other descriptive name: Clobazam PhEur
Trade Name: Clobazam
Product Name: Clobazam Tablets
Product Code: Clobazam Tablets 20mg
INN or Proposed INN: Clobazam
Other descriptive name: Clobazam Pheur
Ovation PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
304Bulgaria;Lithuania
76EUCTR2007-004322-24-BG
(EUCTR)
28/10/200803/11/2008Double-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
INN or Proposed INN: Clobazam
Other descriptive name: Clobazam PhEur
Ovation Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
240Bulgaria;Lithuania
77EUCTR2007-004322-24-LT
(EUCTR)
17/03/200821/01/2008Double-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
INN or Proposed INN: Clobazam
Other descriptive name: Clobazam PhEur
Lundbeck IncNULLNot RecruitingFemale: yes
Male: yes
240Bulgaria;Lithuania
78EUCTR2007-004350-82-LT
(EUCTR)
17/03/200821/01/2008Safety 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
INN or Proposed INN: CLOBAZAM
Other descriptive name: Clobazam PhEur
Trade Name: Clobazam
Product Name: Clobazam Tablets
Product Code: Clobazam Tablets 10mg
INN or Proposed INN: Clobazam
Other descriptive name: Clobazam PhEur
Trade Name: Clobazam
Product Name: Clobazam Tablets
Product Code: Clobazam Tablets 20mg
INN or Proposed INN: Clobazam
Other descriptive name: Clobazam Pheur
Lundbeck IncNULLNot RecruitingFemale: yes
Male: yes
304Bulgaria;Lithuania
79NCT00518713
(ClinicalTrials.gov)
August 200720/8/2007Clobazam 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 LLCNULLCompleted2 Years60 YearsAll238Phase 3United States;Australia;Belarus;India;Lithuania;Serbia
80NCT01160770
(ClinicalTrials.gov)
December 200518/6/2010Safety 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 LLCNULLCompleted2 Years60 YearsAll267Phase 3NULL
81NCT00162981
(ClinicalTrials.gov)
October 20059/9/2005Clobazam 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 LLCNULLCompleted2 Years30 YearsAll68Phase 2United States
82NCT00297349
(ClinicalTrials.gov)
November 200324/2/2006A 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., GreeceNULLCompleted2 YearsN/ABoth153N/ANULL
83NCT00004776
(ClinicalTrials.gov)
November 199324/2/2000Phase 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 AngelesCompleted4 Years30 YearsBoth10Phase 3NULL
84NCT00236756
(ClinicalTrials.gov)
August 19937/10/2005A 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.NULLCompleted12 Months30 YearsBoth100Phase 3NULL
85EUCTR2014-002321-35-PL
(EUCTR)
13/05/2017A 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 Syndrome Seizures associated with Lennox-Gastaut Syndrome (LGS)
MedDRA version: 20.0;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
INN or Proposed INN: perampanel
Other descriptive name: PERAMPANEL
Trade Name: Fycompa
Product Name: perampanel
Product Code: E2007
INN or Proposed INN: Perampanel
Other descriptive name: PERAMPANEL
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
142Phase 3United States;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Latvia;Japan;Italy;Korea, Republic of
86EUCTR2017-002628-26-GB
(EUCTR)
22/05/2018 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 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 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
INN or Proposed INN: Fenfluramine
Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine
Product Name: FENFLURAMINE HYDROCHLORIDE
INN or Proposed INN: Fenfluramine
Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine
Product Name: FENFLURAMINE HYDROCHLORIDE
INN or Proposed INN: Fenfluramine
Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine
Zogenix International Limited, a wholly owned subsidiary of Zogenix Inc.NULLNA Female: yes
Male: yes
225 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Austria;Israel;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden
87EUCTR2010-023505-36-Outside-EU/EEA
(EUCTR)
13/02/2017A 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 ControlledLennox-Gastaut Syndrome Lennox Gastaut Syndrome
MedDRA version: 19.1;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
INN or Proposed INN: RUFINAMIDE
Other descriptive name: Rufinamide oral suspension
Trade Name: Investigators choice of approved AEDs
INN or Proposed INN: Investigators Choice of Approved AED
Other descriptive name: N/A
Eisai LtdNULLNAFemale: yes
Male: yes
75Phase 3United States;Canada
88EUCTR2021-002481-40-LV
(EUCTR)
02/08/2021Study of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut SyndromeA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome (LGS) 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]
Product Name: soticlestat
Product Code: TAK-935
INN or Proposed INN: soticlestat
Product Name: Soticlestat
Product Code: TAK-935
INN or Proposed INN: soticlestat
Takeda Development Center Americas, Inc.NULLNAFemale: yes
Male: yes
234Phase 3Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Latvia;China;Japan
89EUCTR2016-004953-34-Outside-EU/EEA
(EUCTR)
23/02/2017A Long Term Extension Study of E2080 in Patients with Lennox-GastautSyndromeA Long Term Extension Study of E2080 in Patients with Lennox-GastautSyndrome Lennox-Gastaut Syndrome;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Inovelon
Product Name: rufinamide
Product Code: E2080
INN or Proposed INN: RUFINAMIDE
Eisai Co, Ltd.NULLNAFemale: yes
Male: yes
54Phase 3Japan
90EUCTR2014-002321-35-FR
(EUCTR)
21/02/2018A 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 Syndrome Seizures 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
INN or Proposed INN: perampanel
Other descriptive name: PERAMPANEL
Trade Name: Fycompa
Product Name: perampanel
Product Code: E2007
INN or Proposed INN: Perampanel
Other descriptive name: PERAMPANEL
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
142Phase 3United States;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Latvia;Japan;Italy;Korea, Republic of
91EUCTR2021-002482-17-BE
(EUCTR)
20/12/2021Open-Label Extension Study of Soticlestat in Dravet and Lennox-Gastaut SyndromesA Phase 3, Prospective, Open-Label, Multisite, Extension of Phase 3 Studies To Assess the Long-Term Safety and Tolerability of Soticlestat as Adjunctive Therapy in Subjects With Dravet Syndrome or Lennox-Gastaut Syndrome (ENDYMION 2). Dravet Syndrome (DS)Lennox-Gastaut Syndrome (LGS)
MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850
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: soticlestat
Product Code: TAK-935
INN or Proposed INN: SOTICLESTAT
Product Name: soticlestat
Product Code: TAK-935
INN or Proposed INN: SOTICLESTAT
Takeda Development Center Americas, IncNULLNAFemale: yes
Male: yes
376Phase 3United States;Serbia;Greece;Spain;Ukraine;Russian Federation;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Latvia;Netherlands;China;Japan
92EUCTR2017-002628-26-AT
(EUCTR)
16/05/2018 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 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 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
INN or Proposed INN: Fenfluramine
Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine
Product Name: FENFLURAMINE HYDROCHLORIDE
INN or Proposed INN: Fenfluramine
Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine
Product Name: FENFLURAMINE HYDROCHLORIDE
INN or Proposed INN: Fenfluramine
Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine
Zogenix International Limited, a wholly owned subsidiary of Zogenix Inc.NULLNot Recruiting Female: yes
Male: yes
225 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Finland;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden
93EUCTR2012-001132-60-Outside-EU/EEA
(EUCTR)
09/03/2012Study in pediatric subjects with epilepsyOpen-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 LimitedNULLNAFemale: yes
Male: yes
16United States
94EUCTR2019-001331-31-PL
(EUCTR)
20/04/2020A 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 Syndrome Dravet syndrome or Lennox-Gastaut syndrome
MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Fenfluramine hydrochloride (colorless)
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
Other descriptive name: FENFLURAMINE HYDROCHLORIDE
Zogenix International LimitedNULLNAFemale: yes
Male: yes
650Phase 3United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Japan;Sweden
95EUCTR2021-002481-40-FR
(EUCTR)
29/07/2021Study of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut SyndromeA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome (LGS) 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]
Product Name: soticlestat
Product Code: TAK-935
INN or Proposed INN: soticlestat
Product Name: Soticlestat
Product Code: TAK-935
INN or Proposed INN: soticlestat
Takeda Development Center Americas, Inc.NULLNAFemale: yes
Male: yes
234Phase 3Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Latvia;China;Japan
96EUCTR2017-002628-26-PL
(EUCTR)
21/08/2018A Two-Part Study of ZX008 in Children and Adults withLennox-Gastaut Syndrome (LGS); Part 1: A Randomized,Double-blind, Placebo-controlled Trial of Two Fixed Dosesof ZX008 (Fenfluramine Hydrochloride) Oral Solution asAdjunctive Therapy for Seizures in Children and Adults withLGS, Followed by Part 2: An Open-label Extension toAssess Long-Term Safety of ZX008 in Children and Adultswith LGSA Two-Part Study of ZX008 in Children and Adults withLennox-Gastaut Syndrome (LGS); Part 1: A Randomized,Double-blind, Placebo-controlled Trial of Two Fixed Dosesof ZX008 (Fenfluramine Hydrochloride) Oral Solution asAdjunctive Therapy for Seizures in Children and Adults withLGS, Followed by Part 2: An Open-label Extension toAssess Long-Term Safety of ZX008 in Children and Adultswith LGS Lennox-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
INN or Proposed INN: Fenfluramine
Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine
Product Name: FENFLURAMINE HYDROCHLORIDE
INN or Proposed INN: Fenfluramine
Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine
Product Name: FENFLURAMINE HYDROCHLORIDE
INN or Proposed INN: Fenfluramine
Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine
Zogenix International Limited, a wholly owned subsidiary of Zogenix Inc.NULLNot RecruitingFemale: yes
Male: yes
225Phase 3United States;Finland;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden
97EUCTR2016-004952-30-Outside-EU/EEA
(EUCTR)
13/02/2017A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome PatientsA Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients Lennox-Gastaut Syndrome (LSG);Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Inovelon
Product Name: rufinamide
Product Code: E2080
INN or Proposed INN: RUFINAMIDE
Eisai Co, Ltd.NULLNAFemale: yes
Male: yes
58Phase 3Japan
98EUCTR2021-002481-40-Outside-EU/EEA
(EUCTR)
22/07/2021Study of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut SyndromeA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome (LGS) 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]
Product Name: soticlestat
Product Code: TAK-935
INN or Proposed INN: SOTICLESTAT
Product Name: soticlestat
Product Code: TAK-935
INN or Proposed INN: SOTICLESTAT
Takeda Development Center Americas, Inc.NULLNAFemale: yes
Male: yes
Phase 3Australia;Canada;China;Japan;Russian Federation;Serbia;Ukraine;United States;Belgium;France;Greece;Hungary;Italy;Latvia;Netherlands;Poland;Spain;United Kingdom
99EUCTR2010-023505-36-FR
(EUCTR)
19/05/2011A 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 ControlledLennox-Gastaut Syndrome Lennox 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
INN or Proposed INN: RUFINAMIDE
Other descriptive name: Rufinamide oral suspension
Trade Name: Investigators choice of approved AEDs
INN or Proposed INN: Investigators Choice of Approved AED
Other descriptive name: N/A
Eisai LtdNULLNAFemale: yes
Male: yes
75Phase 3United States;France;Greece;Italy;India
100EUCTR2010-020154-33-Outside-EU/EEA
(EUCTR)
09/03/2012Long-term Open-label Evaluation of Retigabine in Pediatric Subjects with EpilepsyRTG113388, 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 LimitedNULLNAFemale: yes
Male: yes
500United States
101EUCTR2019-001331-31-BE
(EUCTR)
26/09/2019A 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 Syndrome Dravet syndrome or Lennox-Gastaut syndrome
MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Fenfluramine hydrochloride (colorless)
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
Other descriptive name: FENFLURAMINE HYDROCHLORIDE
Zogenix International LimitedNULLNAFemale: yes
Male: yes
650Phase 3United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Japan;Sweden