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.
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03778424 (ClinicalTrials.gov) | December 1, 2020 | 27/11/2018 | An Extended Access Program (EAP) for Participants Who Have Completed Rufinamide Study E2080-G000-303 | An Extended Access Program (EAP) for Rufinamide in Pediatric Participants With Inadequately Controlled Lennox-Gastaut Syndrome | Lennox Gastaut Syndrome | Drug: Rufinamide | Eisai Inc. | NULL | Available | 4 Years | N/A | All | Poland | ||
| 2 | NCT04133480 (ClinicalTrials.gov) | October 2020 | 17/10/2019 | Investigation of Cognitive Outcomes With Cannabidiol Oral Solution | An Open-Label Exploratory Investigation of Cognitive Outcomes With Cannabidiol Oral Solution (EPIDIOLEX®; GWP42003-P) | Lennox-Gastaut Syndrome | Drug: GWP42003-P | GW Research Ltd | NULL | Withdrawn | 3 Years | 10 Years | All | 0 | Phase 4 | United States |
| 3 | EUCTR2019-001331-31-SE (EUCTR) | 17/06/2020 | 08/01/2020 | A 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 Syndrome | An 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 Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 650 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Japan;Sweden | ||
| 4 | EUCTR2019-001331-31-DE (EUCTR) | 07/04/2020 | 13/11/2019 | A 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 Syndrome | An 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 Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 650 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Japan;Sweden | ||
| 5 | NCT04611438 (ClinicalTrials.gov) | March 30, 2020 | 16/9/2019 | Research on Cognitive Effect of Cannabidiol on Dravet Syndrome and Lennox-Gastaut SyndromeGastaut Syndrome | A Prospective Multi-Center Single-Arm Clinical Trial on Cognitive Effect of Cannabidiol (CBD-OS®) on Dravet Syndrome and Lennox-Gastaut Syndrome | Dravet Syndrome;Lennox Gastaut Syndrome | Drug: Cannabidiol | Yonsei University | NULL | Recruiting | 2 Years | 18 Years | All | 107 | Phase 3 | Korea, Republic of |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | EUCTR2019-001331-31-NL (EUCTR) | 12/03/2020 | 04/02/2020 | A 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 Syndrome | An 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 Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 650 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Belgium;Poland;Australia;Denmark;Netherlands;Germany;Japan;Sweden | ||
| 7 | EUCTR2019-001331-31-DK (EUCTR) | 17/01/2020 | 26/09/2019 | A 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 Syndrome | An 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 Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 650 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Belgium;Poland;Denmark;Australia;Germany;Netherlands;Japan;Sweden | ||
| 8 | EUCTR2019-001331-31-FR (EUCTR) | 13/12/2019 | 16/10/2019 | A 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 Syndrome | An 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 Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 650 | Phase 3 | Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Netherlands;United States;Spain;United Kingdom;Germany;Japan;Sweden | ||
| 9 | EUCTR2019-001331-31-ES (EUCTR) | 10/12/2019 | 06/11/2019 | A 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 Syndrome | An 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 Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 650 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Japan;Sweden | |||
| 10 | EUCTR2019-001331-31-GB (EUCTR) | 07/11/2019 | 29/08/2019 | A 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 Syndrome | An 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 Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 650 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Japan;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | NCT04062981 (ClinicalTrials.gov) | May 3, 2019 | 30/5/2019 | Carisbamate Safety Study in Adult and Pediatric Subjects With Lennox-Gastaut Syndrome | Phase 1, Open-Label Study of Carisbamate in Adult and Pediatric Subjects With Lennox-Gastaut Syndrome | Lennox Gastaut Syndrome | Drug: Carisbamate | SK Life Science, Inc. | NULL | Recruiting | 2 Years | N/A | All | 30 | Phase 1 | United States |
| 12 | NCT03936777 (ClinicalTrials.gov) | April 22, 2019 | 12/4/2019 | A 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 Syndrome | An 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;Lennox Gastaut Syndrome;Epileptic Encephalopathy | Drug: ZX008 (Fenfluramine Hydrochloride) | Zogenix, Inc. | Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. | Enrolling by invitation | 2 Years | N/A | All | 650 | Phase 3 | United States;Australia;Belgium;Canada;Denmark;Spain;United Kingdom |
| 13 | NCT03731715 (ClinicalTrials.gov) | February 7, 2019 | 16/10/2018 | Carisbamate in Adult & Pediatric Subjects With Lennox-Gastaut Syndrome | Phase I, Open-Label, Pharmacokinetic, Dose Escalation Study of Carisbamate in Adult and Pediatric Subjects With Lennox-Gastaut Syndrome | Lennox Gastaut Syndrome | Drug: Carisbamate | SK Life Science, Inc. | NULL | Recruiting | 2 Years | N/A | All | 24 | Phase 1 | United States |
| 14 | EUCTR2017-002628-26-SE (EUCTR) | 21/01/2019 | 29/05/2018 | A 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 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | United States;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden | ||
| 15 | EUCTR2017-002628-26-FR (EUCTR) | 09/11/2018 | 14/08/2018 | 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 225 | Phase 3 | United States;Finland;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | EUCTR2017-002628-26-NL (EUCTR) | 24/09/2018 | 06/06/2018 | A 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 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 225 | Phase 3 | United States;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden | ||
| 17 | NCT03650452 (ClinicalTrials.gov) | August 8, 2018 | 27/8/2018 | A 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 Encephalopathies | A 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 Encephalopathies | Epilepsy;Dravet Syndrome;Lennox-Gastaut Syndrome | Drug: TAK-935;Drug: Placebo | Takeda | Ovid Therapeutics Inc. | Completed | 2 Years | 17 Years | All | 141 | Phase 2 | United States;Australia;Canada;China;Israel;Poland;Portugal;Spain |
| 18 | EUCTR2017-002628-26-BE (EUCTR) | 23/07/2018 | 30/03/2018 | A 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 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | United States;Finland;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden | ||
| 19 | NCT03635073 (ClinicalTrials.gov) | July 19, 2018 | 6/8/2018 | 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 Rare Epilepsy | 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 Rare Epilepsy | Epilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome, Dup15q Syndrome, CDKL5 Deficiency Disorder | Drug: TAK-935 | Takeda | Ovid Therapeutics Inc. | Recruiting | 2 Years | 65 Years | All | 176 | Phase 2 | United States;Australia;Canada;China;Israel;Poland;Portugal;Spain |
| 20 | EUCTR2017-002628-26-IT (EUCTR) | 16/07/2018 | 25/05/2018 | 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 225 | Phase 3 | United States;Finland;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | EUCTR2017-002628-26-DK (EUCTR) | 09/07/2018 | 17/05/2018 | 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 225 | Phase 3 | United States;Spain;Austria;Israel;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Denmark;Australia;Norway;Netherlands;Germany;Japan;Sweden | |||
| 22 | EUCTR2017-002628-26-ES (EUCTR) | 12/06/2018 | 20/04/2018 | 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] | Product Name: FENFLURAMINE HYDROCHLORIDE INN or Proposed INN: Fenfluramine Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine | Zogenix International Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 225 | Phase 3 | United States;Finland;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden | ||
| 23 | EUCTR2014-002321-35-BE (EUCTR) | 05/06/2018 | 25/04/2017 | A 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 Syndrome | A 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 Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 142 | Phase 3 | France;United States;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Latvia;Japan;Italy;Korea, Republic of | |||
| 24 | NCT03254680 (ClinicalTrials.gov) | March 2018 | 15/8/2017 | Turmeric as Treatment in Epilepsy | Turmeric as Treatment in Epilepsy | Epilepsy;Dravet Syndrome;Lennox-Gastaut Syndrome;Tuberous Sclerosis;Focal Seizures | Dietary Supplement: Turmeric | NYU Langone Health | NULL | Withdrawn | 1 Year | 70 Years | All | 0 | N/A | United States |
| 25 | NCT03467113 (ClinicalTrials.gov) | January 19, 2018 | 30/1/2018 | A Study to Assess the Safety and Tolerability of ZX008 in Children and Young Adults With DS or LGS Currently Taking CBD | An 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 Syndrome | Dravet Syndrome;Lennox Gastaut Syndrome | Drug: ZX008 0.2 and 0.8 mg/kg/day | Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. | NULL | Active, not recruiting | 2 Years | 18 Years | All | 25 | Phase 1;Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | NCT02318537 (ClinicalTrials.gov) | December 30, 2017 | 12/12/2014 | Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Participants With Inadequately Controlled Lennox-Gastaut Syndrome | A 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 Syndrome | Lennox-Gastaut Syndrome | Drug: Cannabidiol Oral Solution;Drug: Placebo Solution | INSYS Therapeutics Inc | NULL | Withdrawn | 2 Years | 30 Years | All | 0 | Phase 3 | NULL |
| 27 | NCT03355209 (ClinicalTrials.gov) | November 27, 2017 | 19/6/2017 | A Study to Investigate the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) as an Adjunctive Therapy in Children and Adults With Lennox-Gastaut Syndrome | A Two-Part Study of ZX008 in Children and Adults With Lennox-Gastaut Syndrome (LGS); Part 1: A Randomized, Double-blind, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as Adjunctive Therapy for Seizures in Children and Adults With LGS, Followed by Part 2: An Open-label Extension to Assess Long-Term Safety of ZX008 in Children and Adults With LGS | Lennox Gastaut Syndrome | Drug: ZX008 0.2 or 0.8 mg/kg/day;Drug: Matching Placebo | Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. | NULL | Recruiting | 2 Years | 35 Years | All | 225 | Phase 3 | United States;Australia;Belgium;Canada;Denmark;France;Germany;Italy;Japan;Mexico;Netherlands;Poland;Spain;Sweden;Austria |
| 28 | EUCTR2014-002321-35-CZ (EUCTR) | 31/08/2017 | 26/05/2017 | A 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 Syndrome | A 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 Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 142 | Phase 3 | United States;Czechia;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Latvia;Japan;Korea, Republic of | ||
| 29 | EUCTR2014-002321-35-LV (EUCTR) | 26/05/2017 | 09/05/2017 | A 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 Syndrome | A 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 142 | Phase 3 | France;United States;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Latvia;Japan;Italy;Korea, Republic of | ||
| 30 | EUCTR2014-002321-35-HU (EUCTR) | 08/05/2017 | 20/04/2017 | A 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 Syndrome | A 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 Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 142 | Phase 3 | France;United States;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Latvia;Japan;Italy;Korea, Republic of | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 31 | NCT02815540 (ClinicalTrials.gov) | February 16, 2017 | 20/6/2016 | The Effects of Cannabidiol (CBD) on Electrical and Autonomic Cardiac Function in Children With Severe Epilepsy | The Effects of Cannabidiol (CBD) on Electrical and Autonomic Cardiac Function in Children | Lennox-Gastaut Syndrome;Dravet Syndrome | Procedure: 12-Lead ECG;Drug: Cannabidiol | Gillette Children's Specialty Healthcare | NULL | Terminated | 2 Years | 30 Years | All | 2 | Phase 1;Phase 2 | United States |
| 32 | NCT02834793 (ClinicalTrials.gov) | December 13, 2016 | 13/7/2016 | Study of Perampanel as Adjunctive Treatment for Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome | A 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) | Drug: Placebo;Drug: Perampanel | Eisai Inc. | NULL | Recruiting | 2 Years | N/A | All | 142 | Phase 3 | United States;Australia;Austria;Belgium;Czechia;India;Japan;Korea, Republic of |
| 33 | JPRN-JapicCTI-173536 | 13/12/2016 | 15/03/2017 | Study of Perampanel as Adjunctive Treatment for Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome | A 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. | NULL | recruiting | 2 | BOTH | 142 | Phase 3 | Japan, Asia except Japan, North America, Europe, Oceania | |
| 34 | NCT02655198 (ClinicalTrials.gov) | January 2016 | 12/1/2016 | Add-on Therapy With Low Dose Fenfluramine in Lennox Gastaut Epilepsy | Add-on Therapy With Low Dose Fenfluramine in Lennox Gastaut Epilepsy | Epilepsy;Lennox Gastaut Syndrome | Drug: Fenfluramine | KU Leuven | Zogenix, Inc. | Active, not recruiting | 3 Years | 18 Years | All | 13 | Phase 2 | Belgium |
| 35 | EUCTR2014-002941-23-NL (EUCTR) | 30/09/2015 | 31/03/2015 | 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 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 100 | United States;Poland;Netherlands | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 36 | EUCTR2014-001834-27-NL (EUCTR) | 09/09/2015 | 18/06/2015 | An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut Syndromes | An 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 680 | Phase 3 | United States;France;Spain;Poland;Australia;Israel;Netherlands;United Kingdom | ||
| 37 | EUCTR2014-001834-27-FR (EUCTR) | 03/09/2015 | 20/07/2015 | An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut Syndromes | An 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 530 | Phase 3 | United States;France;Spain;Poland;Israel;Netherlands;United Kingdom | ||
| 38 | EUCTR2014-001834-27-PL (EUCTR) | 18/08/2015 | 14/05/2015 | An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut Syndromes | An 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 680 | Phase 3 | United States;France;Spain;Poland;Australia;Israel;Netherlands;United Kingdom | ||
| 39 | EUCTR2014-002940-42-GB (EUCTR) | 28/07/2015 | 26/09/2014 | A 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 | A 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | France;United States;Spain;United Kingdom | ||
| 40 | EUCTR2014-002941-23-PL (EUCTR) | 16/07/2015 | 01/04/2015 | 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 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Poland;Netherlands | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 41 | NCT02224560 (ClinicalTrials.gov) | June 8, 2015 | 21/8/2014 | Efficacy and Safety of GWP42003-P for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults | A 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 Syndrome | Drug: GWP42003-P;Drug: Placebo control | GW Research Ltd | NULL | Completed | 2 Years | 55 Years | All | 225 | Phase 3 | United States;France;Spain;United Kingdom |
| 42 | NCT02224573 (ClinicalTrials.gov) | June 2015 | 21/8/2014 | GWPCARE5 - An Open Label Extension Study of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet or Lennox-Gastaut Syndromes | An 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 Syndrome | Drug: GWP42003-P | GW Research Ltd | NULL | Completed | 2 Years | N/A | All | 681 | Phase 3 | NULL |
| 43 | EUCTR2014-001834-27-ES (EUCTR) | 21/05/2015 | 14/04/2015 | An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut Syndromes | An 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 430 | Phase 3 | France;United States;Poland;Spain;Israel;Netherlands;United Kingdom | |||
| 44 | NCT02224690 (ClinicalTrials.gov) | April 28, 2015 | 21/8/2014 | A 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 | A 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 Syndrome | Drug: GWP42003-P 20 mg/kg/day Dose;Drug: Placebo | GW Research Ltd | NULL | Completed | 2 Years | 55 Years | All | 171 | Phase 3 | United States;Netherlands;Poland |
| 45 | EUCTR2014-002940-42-ES (EUCTR) | 08/04/2015 | 16/12/2014 | A 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 | A 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 3 | France;United States;Spain;United Kingdom | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 46 | EUCTR2014-001834-27-GB (EUCTR) | 14/01/2015 | 30/09/2014 | An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut Syndromes | An 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 680 | Phase 3 | France;United States;Poland;Spain;Australia;Israel;Netherlands;United Kingdom | ||
| 47 | NCT02307578 (ClinicalTrials.gov) | March 2014 | 2/12/2014 | An Extended Access Program (EAP) for Perampanel | An Extended Access Program (EAP) for Perampanel | Primary Generalized Tonic-Clonic or Partial Onset Seizures;Lennox Gastaut Syndrome | Drug: Perampanel | Eisai Inc. | NULL | Available | 1 Year | N/A | All | Belgium;Chile;Estonia;Hungary;Latvia;Lithuania;Poland;Spain | ||
| 48 | NCT02175173 (ClinicalTrials.gov) | June 13, 2013 | 10/6/2014 | Post-marketing Surveillance of Long-term Administration of Inovelon Tablets in Patients With Lennox-Gastaut Syndrome | Lennox-Gastaut Syndrome | Drug: Rufinamide | Eisai Co., Ltd. | NULL | Recruiting | N/A | N/A | All | 728 | Japan | ||
| 49 | JPRN-JapicCTI-132169 | 29/5/2013 | 21/06/2013 | Post-marketing surveillance of long-term administration of Inovelon tablets in patients with Lennox-Gastaut syndrome | Post-marketing surveillance of long-term administration of Inovelon tablets in patients with Lennox-Gastaut syndrome | Lennox-Gastaut syndrome | Intervention 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. | NULL | recruiting | BOTH | 300 | NA | Japan | ||
| 50 | NCT01668654 (ClinicalTrials.gov) | September 4, 2012 | 17/5/2012 | Long-term, Open-label Safety Extension Study of Retigabine/Ezogabine in Pediatric Subjects (>= 12 Years Old) With POS or LGS | RTG113388, a Long-term, Open-label Safety Extension Study of Retigabine/Ezogabine in Pediatric Subjects With Partial Onset Seizures (>= 12 Years Old) and Subjects With Lennox-Gastaut Syndrome (>=12 Years Old) | Epilepsy | Drug: retigabine/ezogabine | GlaxoSmithKline | Bausch Health Americas, Inc. | Terminated | 12 Years | 29 Years | All | 4 | Phase 3 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 51 | EUCTR2010-023505-36-GR (EUCTR) | 08/08/2012 | 08/08/2012 | A 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 75 | United States;Greece;South Africa;Italy | |||
| 52 | NCT01494584 (ClinicalTrials.gov) | July 25, 2012 | 1/12/2011 | Study in Pediatric Subjects With Epilepsy | Open-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 Syndrome | Epilepsy | Drug: ezogabine/retigabine | GlaxoSmithKline | Bausch Health Americas, Inc. | Terminated | 12 Years | 17 Years | All | 5 | Phase 2 | United States |
| 53 | EUCTR2010-023505-36-IT (EUCTR) | 29/09/2011 | 05/01/2012 | A Multicenter, Randomized, Controlled, Open-label Study to Evaluate the Cognitive Development Effects and Safety, and Pharmacokinetics of Adjunctive Rufinamide Treatment in Pediatric Subjects 1 to less than 4 years of age with Inadequately Controlled Lennox-Gastaut Syndrome | A Multicenter, Randomized, Controlled, Open-label Study to Evaluate the Cognitive Development Effects and Safety, and Pharmacokinetics of Adjunctive Rufinamide Treatment in Pediatric Subjects 1 to less than 4 years of age with Inadequately Controlled Lennox-Gastaut 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 UK | NULL | Not Recruiting | Female: yes Male: yes | 75 | Greece;Italy | |||
| 54 | NCT01370486 (ClinicalTrials.gov) | August 2011 | 8/6/2011 | Melatonin Versus Placebo in the Lennox-Gastaut Syndrome: Neurophysiological and Neuropsychological Effects | Double Blind, Randomised, Cross-over Study Melatonin Versus Placebo in the Lennox-Gastaut Syndrome: Neurophysiological and Neuropsychological Effects | Lennox-Gastaut Syndrome | Drug: melatonin;Drug: placebo | Institution de Lavigny | NULL | Not yet recruiting | 18 Years | 55 Years | Both | 6 | Phase 4 | Switzerland |
| 55 | NCT01405053 (ClinicalTrials.gov) | June 16, 2011 | 27/7/2011 | Study of Rufinamide in Pediatric Subjects 1 to Less Than 4 Years of Age With Lennox-Gastaut Syndrome Inadequately Controlled With Other Anti-epileptic Drugs | A Multicenter, Randomized, Controlled, Open-label Study to Evaluate the Cognitive Development Effects and Safety, and Pharmacokinetics of Adjunctive Rufinamide Treatment in Pediatric Subjects 1 to Less Than 4 Years of Age With Inadequately Controlled Lennox-Gastaut Syndrome | Lennox-Gastaut Syndrome | Drug: Rufinamide;Drug: Any other approved Antiepileptic Drug | Eisai Inc. | NULL | Completed | 1 Year | 3 Years | All | 37 | Phase 3 | United States;Canada;France;Greece;Italy;Poland;South Africa;India |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 56 | NCT01151540 (ClinicalTrials.gov) | November 2010 | 14/6/2010 | A Long Term Extension Study of E2080 in Lennox-Gastaut Patients | A Long Term Extension Study of E2080 in Lennox-Gastaut Patients | Lennox-Gastaut Syndrome | Drug: Rufinamide | Eisai Co., Ltd. | NULL | Completed | 4 Years | 30 Years | All | 54 | Phase 3 | Japan |
| 57 | NCT01146951 (ClinicalTrials.gov) | June 2010 | 14/6/2010 | A 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 Patients | Lennox-Gastaut Syndrome | Drug: Rufinamide (E2080);Drug: Placebo | Eisai Limited | NULL | Completed | 4 Years | 30 Years | All | 66 | Phase 3 | Japan |
| 58 | EUCTR2007-004350-82-BG (EUCTR) | 10/11/2008 | 13/11/2008 | Safety 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 Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 304 | Bulgaria;Lithuania | ||||
| 59 | EUCTR2007-004322-24-BG (EUCTR) | 28/10/2008 | 03/11/2008 | 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. | 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. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Bulgaria;Lithuania | |||
| 60 | EUCTR2007-004350-82-LT (EUCTR) | 17/03/2008 | 21/01/2008 | Safety 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 Inc | NULL | Not Recruiting | Female: yes Male: yes | 304 | Bulgaria;Lithuania | ||||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 61 | EUCTR2007-004322-24-LT (EUCTR) | 17/03/2008 | 21/01/2008 | 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. | 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 Inc | NULL | Not Recruiting | Female: yes Male: yes | 240 | Bulgaria;Lithuania | |||
| 62 | NCT00518713 (ClinicalTrials.gov) | August 2007 | 20/8/2007 | Clobazam in Patients With Lennox-Gastaut Syndrome | Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Clobazam in Patients With Lennox-Gastaut Syndrome | Epilepsy;Epilepsy, Generalized;Seizures | Drug: Clobazam Low Dose;Drug: Clobazam Medium Dose;Drug: Clobazam High Dose;Drug: Placebo | Lundbeck LLC | NULL | Completed | 2 Years | 60 Years | All | 238 | Phase 3 | United States;Australia;Belarus;India;Lithuania;Serbia |
| 63 | NCT01160770 (ClinicalTrials.gov) | December 2005 | 18/6/2010 | Safety and Effectiveness of Open-Label Clobazam in Subjects With Lennox-Gastaut Syndrome | Safety and Effectiveness of Open-Label Clobazam in Subjects With Lennox-Gastaut Syndrome | Lennox-Gastaut Syndrome | Drug: Clobazam | Lundbeck LLC | NULL | Completed | 2 Years | 60 Years | All | 267 | Phase 3 | NULL |
| 64 | NCT00162981 (ClinicalTrials.gov) | October 2005 | 9/9/2005 | Clobazam in Subjects With Lennox-Gastaut Syndrome | Safety and Efficacy of Clobazam in Subjects With Lennox-Gastaut Syndrome | Epilepsy;Epilepsy, Generalized;Seizures | Drug: Clobazam Low Dose;Drug: Clobazam High Dose | Lundbeck LLC | NULL | Completed | 2 Years | 30 Years | All | 68 | Phase 2 | United States |
| 65 | NCT00297349 (ClinicalTrials.gov) | November 2003 | 24/2/2006 | A Study of the Safety of Topiramate Given in Combination With Other Medications in Adults and Children With Seizures | An 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 Older | Seizures;Epilepsy | Drug: Topiramate | Janssen Cilag Pharmaceutica S.A.C.I., Greece | NULL | Completed | 2 Years | N/A | Both | 153 | N/A | NULL |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 66 | NCT00004776 (ClinicalTrials.gov) | November 1993 | 24/2/2000 | Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Topiramate for Lennox-Gastaut Syndrome | Lennox-Gastaut Syndrome | Drug: topiramate | National Center for Research Resources (NCRR) | University of California, Los Angeles | Completed | 4 Years | 30 Years | Both | 10 | Phase 3 | NULL | |
| 67 | NCT00236756 (ClinicalTrials.gov) | August 1993 | 7/10/2005 | A Study of the Efficacy and Safety of Topiramate as an add-on Therapy in the Treatment of Epilepsy Patients With Lennox-Gastaut Syndrome | A Double-Blind Trial of Topiramate in Subjects With Lennox-Gastaut Syndrome. | Epilepsy;Seizures | Drug: topiramate | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | NULL | Completed | 12 Months | 30 Years | Both | 100 | Phase 3 | NULL |
| 68 | EUCTR2016-004952-30-Outside-EU/EEA (EUCTR) | 13/02/2017 | A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients | A 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. | NULL | NA | Female: yes Male: yes | 58 | Phase 3 | Japan | |||
| 69 | EUCTR2019-001331-31-BE (EUCTR) | 26/09/2019 | A 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 Syndrome | An 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 Limited | NULL | NA | Female: yes Male: yes | 650 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Japan;Sweden | |||
| 70 | EUCTR2012-001132-60-Outside-EU/EEA (EUCTR) | 09/03/2012 | Study in pediatric subjects with epilepsy | Open-label, multiple dose study to evaluate thepharmacokinetics, safety and tolerability of ezogabine/retigabineas adjunctive treatment in subjects aged from 12 years to lessthan 18 years with partial onset seizures or Lennox-Gastautsyndrome | Uncontrolled partial onset seizures or Lennox Gastaut Syndrome MedDRA version: 14.1;Level: PT;Classification code 10061334;Term: Partial seizures;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Potiga Product Name: Retigabine/Ezogabine Product Code: GW582892 INN or Proposed INN: RETIGABINE Other descriptive name: EZOGABINE (US ONLY) INN or Proposed INN: RETIGABINE Other descriptive name: EZOGABINE (US ONLY) INN or Proposed INN: RETIGABINE Other descriptive name: EZOGABINE (US ONLY) Product Name: Retigabine/Ezogabine INN or Proposed INN: RETIGABINE Other descriptive name: EZOGABINE (US ONLY) Product Name: Retigabine/Ezogabine INN or Proposed INN: RETIGABINE Other descriptive name: EZOGABINE (US ONLY) | GlaxoSmithKline R&D Limited | NULL | NA | Female: yes Male: yes | 16 | United States | ||||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 71 | EUCTR2017-002628-26-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. | NULL | NA | Female: yes Male: yes | 225 | Phase 3 | United States;Spain;Austria;Israel;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden | ||||
| 72 | EUCTR2010-023505-36-FR (EUCTR) | 19/05/2011 | A 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 Ltd | NULL | NA | Female: yes Male: yes | 75 | Phase 3 | United States;France;Greece;Italy;India | |||
| 73 | EUCTR2016-004953-34-Outside-EU/EEA (EUCTR) | 23/02/2017 | A Long Term Extension Study of E2080 in Patients with Lennox-GastautSyndrome | A 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. | NULL | NA | Female: yes Male: yes | 54 | Phase 3 | Japan | |||
| 74 | EUCTR2017-002628-26-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. | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 3 | United States;Finland;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden | ||||
| 75 | EUCTR2017-002628-26-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. | NULL | NA | Female: yes Male: yes | 225 | Phase 3 | United States;Finland;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden | ||||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 76 | EUCTR2019-001331-31-PL (EUCTR) | 20/04/2020 | A 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 Syndrome | An 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 Limited | NULL | NA | Female: yes Male: yes | 650 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Japan;Sweden | |||
| 77 | EUCTR2014-002321-35-FR (EUCTR) | 21/02/2018 | A 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 Syndrome | A 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 Limited | NULL | NA | Female: yes Male: yes | 142 | Phase 3 | United States;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Latvia;Japan;Italy;Korea, Republic of | |||
| 78 | EUCTR2010-020154-33-Outside-EU/EEA (EUCTR) | 09/03/2012 | Long-term Open-label Evaluation of Retigabine in Pediatric Subjects with Epilepsy | RTG113388, a Long-term, Open-label Safety Extension Study ofRetigabine/Ezogabine in Pediatric Subjects with Partial OnsetSeizures(=12 years old) and Subjects with Lennox-GastautSyndrome (=12 years old) - Long-term Open-label Safety Extension Study of Retigabine/Ezogabine in subjects >=12yrs with POS/LGS | Uncontrolled partial onset seizures or Lennox Gastaut Syndrome MedDRA version: 14.1;Level: PT;Classification code 10061334;Term: Partial seizures;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: RETIGABINE/EZOGABINE Product Code: GW582892 INN or Proposed INN: RETIGABINE Other descriptive name: EZOGABINE (US ONLY) Trade Name: Potiga Product Name: RETIGABINE/EZOGABINE Product Code: GW582892 INN or Proposed INN: RETIGABINE Other descriptive name: EZOGABINE (US ONLY) INN or Proposed INN: RETIGABINE Other descriptive name: EZOGABINE (US ONLY) INN or Proposed INN: RETIGABINE Other descriptive name: EZOGABINE (US ONLY) INN or Proposed INN: RETIGABINE Other descriptive name: EZOGABINE (US only) Product Name: RETIGABINE/EZOGABINE Product Code: GW582892 INN or Proposed INN: RETIGABINE Other descriptive name: EZOGABINE (US ONLY) | GlaxoSmithKline R&D Limited | NULL | NA | Female: yes Male: yes | 500 | United States | ||||
| 79 | EUCTR2017-002628-26-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. | NULL | NA | Female: yes Male: yes | 225 | Phase 3 | United States;Finland;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Japan;Sweden | ||||
| 80 | EUCTR2010-023505-36-Outside-EU/EEA (EUCTR) | 13/02/2017 | A 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 Ltd | NULL | NA | Female: yes Male: yes | 75 | Phase 3 | United States;Canada |