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

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

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03778424
(ClinicalTrials.gov)
December 1, 202027/11/2018An 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
2NCT04133480
(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
3EUCTR2019-001331-31-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;United Kingdom;Italy;France;Mexico;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Japan;Sweden
4EUCTR2019-001331-31-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;United Kingdom;Italy;France;Mexico;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Japan;Sweden
5NCT04611438
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2019-001331-31-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
7EUCTR2019-001331-31-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
8EUCTR2019-001331-31-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
9EUCTR2019-001331-31-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]
Zogenix International LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
650Phase 3United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Japan;Sweden
10EUCTR2019-001331-31-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT04062981
(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
12NCT03936777
(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;Spain;United Kingdom
13NCT03731715
(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
14EUCTR2017-002628-26-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.NULLAuthorised-recruitment may be ongoing or finishedFemale: 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
15EUCTR2017-002628-26-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]
Zogenix International Limited, a wholly owned subsidiary of Zogenix Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
225Phase 3United States;Finland;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2017-002628-26-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;Italy;United Kingdom;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden
17NCT03650452
(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 Patients With Developmental and/or Epileptic EncephalopathiesA Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 as an Adjunctive Therapy in Pediatric Patients With Developmental and/or Epileptic EncephalopathiesEpilepsy;Dravet Syndrome;Lennox-Gastaut SyndromeDrug: TAK-935;Drug: PlaceboTakedaOvid Therapeutics Inc.Completed2 Years17 YearsAll141Phase 2United States;Australia;Canada;China;Israel;Poland;Portugal;Spain
18EUCTR2017-002628-26-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.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;Norway;Netherlands;Germany;Japan;Sweden
19NCT03635073
(ClinicalTrials.gov)
July 19, 20186/8/2018A Phase 2, Prospective, Interventional, Open-Label, Multi-Site, Extension Study to Assess the Long-Term Safety and Tolerability of TAK-935 (OV935) as Adjunctive Therapy in Patients With Rare EpilepsyA Phase 2, Prospective, Interventional, Open-Label, Multi-Site, Extension Study to Assess the Long-Term Safety and Tolerability of TAK-935 (OV935) as Adjunctive Therapy in Patients With Rare EpilepsyEpilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome, Dup15q Syndrome, CDKL5 Deficiency DisorderDrug: TAK-935TakedaOvid Therapeutics Inc.Recruiting2 Years65 YearsAll176Phase 2United States;Australia;Canada;China;Israel;Poland;Portugal;Spain
20EUCTR2017-002628-26-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]
Zogenix International Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
225Phase 3United States;Finland;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2017-002628-26-DK
(EUCTR)
09/07/201817/05/2018 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]
Zogenix International Limited, a wholly owned subsidiary of Zogenix Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
225Phase 3United States;Spain;Austria;Israel;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Denmark;Australia;Norway;Netherlands;Germany;Japan;Sweden
22EUCTR2017-002628-26-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
23EUCTR2014-002321-35-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]
Eisai LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
142Phase 3France;United States;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Latvia;Japan;Italy;Korea, Republic of
24NCT03254680
(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
25NCT03467113
(ClinicalTrials.gov)
January 19, 201830/1/2018A Study to Assess the Safety and Tolerability of ZX008 in Children and Young Adults With DS or LGS Currently Taking CBDAn Open-Label Trial to Assess the Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Combination With Cannabidiol, as an Adjunctive Therapy in Children and Young Adults With Dravet Syndrome or Lennox-Gastaut SyndromeDravet Syndrome;Lennox Gastaut SyndromeDrug: ZX008 0.2 and 0.8 mg/kg/dayZogenix International Limited, Inc., a subsidiary of Zogenix, Inc.NULLActive, not recruiting2 Years18 YearsAll25Phase 1;Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT02318537
(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
27NCT03355209
(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.NULLRecruiting2 Years35 YearsAll225Phase 3United States;Australia;Belgium;Canada;Denmark;France;Germany;Italy;Japan;Mexico;Netherlands;Poland;Spain;Sweden;Austria
28EUCTR2014-002321-35-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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
142Phase 3United States;Czechia;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Latvia;Japan;Korea, Republic of
29EUCTR2014-002321-35-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
30EUCTR2014-002321-35-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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
142Phase 3France;United States;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Latvia;Japan;Italy;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT02815540
(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
32NCT02834793
(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.NULLRecruiting2 YearsN/AAll142Phase 3United States;Australia;Austria;Belgium;Czechia;India;Japan;Korea, Republic of
33JPRN-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.NULLrecruiting2BOTH142Phase 3Japan, Asia except Japan, North America, Europe, Oceania
34NCT02655198
(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
35EUCTR2014-002941-23-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2014-001834-27-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
37EUCTR2014-001834-27-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
38EUCTR2014-001834-27-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
39EUCTR2014-002940-42-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
40EUCTR2014-002941-23-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41NCT02224560
(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
42NCT02224573
(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
43EUCTR2014-001834-27-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]
GW Research LtdNULLNot Recruiting Female: yes
Male: yes
430Phase 3France;United States;Poland;Spain;Israel;Netherlands;United Kingdom
44NCT02224690
(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
45EUCTR2014-002940-42-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2014-001834-27-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
47NCT02307578
(ClinicalTrials.gov)
March 20142/12/2014An 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/AAllBelgium;Chile;Estonia;Hungary;Latvia;Lithuania;Poland;Spain
48NCT02175173
(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
49JPRN-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
50NCT01668654
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2010-023505-36-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
52NCT01494584
(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
53EUCTR2010-023505-36-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
54NCT01370486
(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
55NCT01405053
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56NCT01151540
(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
57NCT01146951
(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
58EUCTR2007-004350-82-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
59EUCTR2007-004322-24-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
60EUCTR2007-004322-24-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2007-004350-82-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
62NCT00518713
(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
63NCT01160770
(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
64NCT00162981
(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
65NCT00297349
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66NCT00004776
(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
67NCT00236756
(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
68EUCTR2017-002628-26-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]
Zogenix International Limited, a wholly owned subsidiary of Zogenix Inc.NULLNA Female: yes
Male: yes
225Phase 3United States;Spain;Austria;Israel;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden
69EUCTR2010-023505-36-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
70EUCTR2016-004953-34-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71EUCTR2014-002321-35-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 LimitedNULLNAFemale: yes
Male: yes
142Phase 3United States;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Latvia;Japan;Italy;Korea, Republic of
72EUCTR2017-002628-26-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]
Zogenix International Limited, a wholly owned subsidiary of Zogenix Inc.NULLNot Recruiting Female: 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
73EUCTR2012-001132-60-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
74EUCTR2019-001331-31-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
75EUCTR2017-002628-26-PL
(EUCTR)
21/08/2018 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]
Zogenix International Limited, a wholly owned subsidiary of Zogenix Inc.NULLNA Female: yes
Male: yes
225Phase 3United States;Finland;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76EUCTR2016-004952-30-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
77EUCTR2017-002628-26-DE
(EUCTR)
11/04/2018 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]
Zogenix International Limited, a wholly owned subsidiary of Zogenix Inc.NULLNA Female: yes
Male: yes
225Phase 3United States;Finland;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Japan;Sweden
78EUCTR2010-023505-36-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
79EUCTR2010-020154-33-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
80EUCTR2019-001331-31-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