144. Lennox-Gastaut syndrome
[
41 clinical trials,
43 drugs（DrugBank:
10 drugs),
49 target genes / 55 target pathways ]
Searched query = "Lennox Gastaut syndrome"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/20/2019, 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04133480 | December 9, 2019 | 28 October 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 | Not recruiting | 3 Years | 10 Years | All | 116 | Phase 4 | United States | |
| 2 | NCT04062981 | May 3, 2019 | 9 September 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. | Recruiting | 2 Years | N/A | All | 30 | Phase 1 | United States | |
| 3 | NCT03936777 | April 22, 2019 | 24 June 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. | Recruiting | 2 Years | N/A | All | 650 | Phase 3 | United States |
| 4 | NCT03731715 | February 7, 2019 | 26 August 2019 | 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. | Recruiting | 2 Years | N/A | All | 24 | Phase 1 | United States | |
| 5 | NCT03650452 | August 8, 2018 | 4 November 2019 | 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. | Recruiting | 2 Years | 17 Years | All | 126 | Phase 2 | United States;Australia;Canada;China;Israel;Poland;Portugal;Spain |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | EUCTR2017-002628-26-BE | 23/07/2018 | 15 October 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 Pharmaceutical Form: Oral solution INN or Proposed INN: Fenfluramine CAS Number: 404-82-0 Current Sponsor code: ZX008 Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine Concentration unit: mg/ml milligram(s)/millilitre Concentration type: up to Concentration number: 5- Pharmaceutical form of the placebo: Oral solution Route of administration of the placebo: Oral use | Zogenix International Limited | Authorised | 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 | |||
| 7 | NCT03635073 | July 19, 2018 | 22 October 2019 | 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;China;Israel;Poland;Spain |
| 8 | EUCTR2017-002628-26-ES | 12/06/2018 | 18 June 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 Pharmaceutical Form: Oral solution INN or Proposed INN: Fenfluramine CAS Number: 404-82-0 Current Sponsor code: ZX008 Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine Concentration unit: mg/ml milligram(s)/millilitre Concentration type: up to Concentration number: 5- Pharmaceutical form of the placebo: Oral solution Route of administration of the placebo: Oral use | Zogenix International Limited | Authorised | 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 | |||
| 9 | EUCTR2014-002321-35-BE | 05/06/2018 | 28 February 2019 | 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: perampanel CAS Number: 380917-97-5 Current Sponsor code: E2007 Other descriptive name: PERAMPANEL Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Trade Name: Fycompa Product Name: perampanel Product Code: E2007 Pharmaceutical Form: Oral suspension INN or Proposed INN: Perampanel CAS Number: 380917-97-5 Current Sponsor code: E2007 Other descriptive name: PERAMPANEL Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 0.5- Pharmaceutical form of the placebo: Oral suspension Route of administration of the placebo: Oral use | Eisai Limited | Authorised | Female: yes Male: yes | 142 | Phase 3 | Korea, Republic of;Italy;Japan;Latvia;Australia;Belgium;Poland;Canada;Czech Republic;Hungary;United States;France | |||
| 10 | NCT03254680 | March 2018 | 11 June 2018 | Turmeric as Treatment in Epilepsy | Turmeric as Treatment in Epilepsy | Epilepsy;Dravet Syndrome;Lennox-Gastaut Syndrome;Tuberous Sclerosis;Focal Seizures | Dietary Supplement: Turmeric | New York University School of Medicine | Not recruiting | 1 Year | 70 Years | All | 0 | N/A | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | NCT03467113 | January 19, 2018 | 30 September 2019 | 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. | Not recruiting | 2 Years | 18 Years | All | 25 | Phase 1/Phase 2 | United States | |
| 12 | NCT02318537 | December 30, 2017 | 18 January 2018 | 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 | Not recruiting | 2 Years | 30 Years | All | 0 | Phase 3 | ||
| 13 | NCT03355209 | November 27, 2017 | 30 September 2019 | 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. | 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 | |
| 14 | NCT02815540 | February 16, 2017 | 11 March 2019 | 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 | Drug: Cannabidiol;Procedure: 12-Lead ECG | Gillette Children's Specialty Healthcare | Not recruiting | 2 Years | 30 Years | All | 2 | Phase 1/Phase 2 | United States | |
| 15 | EUCTR2017-002628-26-DE | 7 January 2019 | 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 Pharmaceutical Form: Oral solution INN or Proposed INN: Fenfluramine CAS Number: 404-82-0 Current Sponsor code: ZX008 Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Oral solution Route of administration of the placebo: Oral use Product Name: FENFLURAMINE HYDROCHLORIDE Pharmaceutical Form: Oral solution INN or Proposed INN: Fenfluramine CAS Number: 404-82-0 Current Sponsor code: ZX008 Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 2.5- Pharmaceutical form of the placebo: Oral solution Route of administration of the placebo: Oral use Product Name: FENFLURAMINE HYDROCHLORIDE Pharmaceutical Form: Oral solution INN or Proposed INN: Fenfluramine CAS Number: 404-82-0 Current Sponsor code: ZX008 Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1.25- Pharmaceutical form of the placebo: Oral solution Route of administration of the placebo: Oral use | Zogenix International Limited, a wholly owned subsidiary of Zogenix Inc. | Not Available | 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_ enrollement | Last_Refreshed_ on | 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-IT | 17 September 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 Pharmaceutical Form: Oral solution INN or Proposed INN: Fenfluramine CAS Number: 404-82-0 Current Sponsor code: ZX008 Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine Concentration unit: mg/ml milligram(s)/millilitre Concentration type: up to Concentration number: 5- Pharmaceutical form of the placebo: Oral solution Route of administration of the placebo: Oral use | Zogenix International Inc. | Not Available | 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 | ||||
| 17 | EUCTR2017-002628-26-NL | 11 June 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 Pharmaceutical Form: Oral solution INN or Proposed INN: Fenfluramine CAS Number: 404-82-0 Current Sponsor code: ZX008 Other descriptive name: Fenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine Concentration unit: mg/ml milligram(s)/millilitre Concentration type: up to Concentration number: 5- Pharmaceutical form of the placebo: Oral solution Route of administration of the placebo: Oral use | Zogenix International Limited | Not Available | 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;Germany;Netherlands;Japan;Sweden | ||||
| 18 | JPRN-JapicCTI-173536 | 13/12/2016 | 10 September 2019 | 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 : (1)subjects >=12 years of age: Perampanel oral tablets, 2 mg (2)subjects <12 years of age: Perampanel 0.5 milligrams per milliliter (mg/mL) oral suspension Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Matching-placebo | Eisai Co., Ltd. | Recruiting | 2 | BOTH | 142 | Phase 3 | Japan, Asia except Japan, North America, Europe, Oceania | ||
| 19 | NCT02834793 | December 13, 2016 | 28 October 2019 | 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. | Recruiting | 2 Years | N/A | All | 142 | Phase 3 | United States;Australia;Belgium;Czechia;Japan;Korea, Republic of | |
| 20 | NCT02655198 | January 2016 | 11 February 2019 | 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. | Not recruiting | 3 Years | 18 Years | All | 13 | Phase 2 | Belgium |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | NCT02224560 | June 8, 2015 | 20 August 2018 | 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 | Not recruiting | 2 Years | 55 Years | All | 225 | Phase 3 | United States;France;Spain;United Kingdom | |
| 22 | NCT02224573 | June 2015 | 17 June 2019 | 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 | Not recruiting | 2 Years | N/A | All | 681 | Phase 3 | ||
| 23 | NCT02224690 | April 28, 2015 | 20 August 2018 | 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 | Not recruiting | 2 Years | 55 Years | All | 171 | Phase 3 | United States;Netherlands;Poland | |
| 24 | NCT02175173 | June 13, 2013 | 25 February 2019 | Post-marketing Surveillance of Long-term Administration of Inovelon Tablets in Patients With Lennox-Gastaut Syndrome | Lennox-Gastaut Syndrome | Drug: Rufinamide | Eisai Co., Ltd. | Recruiting | N/A | N/A | All | 728 | Phase 3 | Japan | ||
| 25 | JPRN-JapicCTI-132169 | 29/5/2013 | 16 July 2019 | 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 : Rufinamide(Inovelon) Dosage And administration of the intervention : Oral | Eisai Co., Ltd. | Recruiting | BOTH | 300 | NA | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | NCT01668654 | September 4, 2012 | 2 July 2018 | 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 | Valeant Pharmaceuticals International, Inc. | Not recruiting | 12 Years | 29 Years | All | 4 | Phase 3 | United States |
| 27 | NCT01494584 | July 25, 2012 | 2 July 2018 | 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 | Valeant Pharmaceuticals International, Inc. | Not recruiting | 12 Years | 17 Years | All | 5 | Phase 2 | United States |
| 28 | NCT01370486 | August 2011 | 19 February 2015 | 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 | Not recruiting | 18 Years | 55 Years | Both | 6 | Phase 4 | Switzerland | |
| 29 | NCT01405053 | June 2011 | 11 April 2016 | 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 AED | Eisai Inc. | Not recruiting | 1 Year | 3 Years | Both | 37 | Phase 3 | United States;Canada;France;Greece;Italy;Poland;India;South Africa | |
| 30 | NCT01151540 | November 2010 | 19 February 2015 | 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: E2080 | Eisai Co., Ltd. | Not recruiting | N/A | N/A | Both | 54 | Phase 3 | Japan | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 31 | NCT01146951 | June 2010 | 19 October 2017 | 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 | Not recruiting | 4 Years | 30 Years | All | 66 | Phase 3 | Japan | |
| 32 | EUCTR2010-020154-33-Outside-EU/EEA | 20 March 2012 | Long-term Open-label Evaluation of Retigabine in Pediatric Subjects with Epilepsy | 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) - 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 Level: PT Classification code 10048816 Term: Lennox-Gastaut syndrome System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: RETIGABINE/EZOGABINE Product Code: GW582892 Pharmaceutical Form: Tablet INN or Proposed INN: RETIGABINE CAS Number: 150812-12-7 Current Sponsor code: GW582892 Other descriptive name: EZOGABINE (US ONLY) Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Trade Name: Potiga Product Name: RETIGABINE/EZOGABINE Product Code: GW582892 Pharmaceutical Form: Tablet INN or Proposed INN: RETIGABINE CAS Number: 150812-12-7 Current Sponsor code: GW582892 Other descriptive name: EZOGABINE (US ONLY) Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- INN or Proposed INN: RETIGABINE CAS Number: 150812-12-7 Current Sponsor code: GW582892 Other descriptive name: EZOGABINE (US ONLY) Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- INN or Proposed INN: RETIGABINE CAS Number: 150812-12-7 Current Sponsor code: GW582892 Other descriptive name: EZOGABINE (US ONLY) Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- INN or Proposed INN: RETIGABINE CAS Number: 150812-12-7 Current Sponsor code: GW52892 Other descriptive name: EZOGABINE (US only) Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400- Product Name: RETIGABINE/EZOGABINE Product Code: GW582892 Pharmaceutical Form: Tablet INN or Proposed INN: RETIGABINE CAS Number: 150812-12-7 Current Sponsor code: GW582892 Other descriptive name: EZOGABINE (US ONLY) Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- | GlaxoSmithKline R&D Limited | Not Available | Female: yes Male: yes | 500 | United States | |||||
| 33 | EUCTR2010-023505-36-FR | 2 October 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 Controlled Lennox-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 Pharmaceutical Form: Oral suspension INN or Proposed INN: RUFINAMIDE CAS Number: 106308-44-5 Current Sponsor code: E2080 Other descriptive name: Rufinamide oral suspension Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 40- Trade Name: Investigators choice of approved AEDs Pharmaceutical Form: INN or Proposed INN: Investigators Choice of Approved AED CAS Number: N/A Current Sponsor code: N/A Other descriptive name: N/A | Eisai Ltd | Not Available | Female: yes Male: yes | 75 | Phase 3 | United States;France;Greece;Italy;India | ||||
| 34 | EUCTR2007-004322-24-LT | 17/03/2008 | 19 March 2012 | 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 Pharmaceutical Form: Tablet INN or Proposed INN: Clobazam CAS Number: 22316-47-8 Other descriptive name: Clobazam PhEur Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Lundbeck Inc | Not Recruiting | Female: yes Male: yes | 240 | Bulgaria;Lithuania | ||||
| 35 | EUCTR2007-004350-82-LT | 17/03/2008 | 25 September 2012 | 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 Pharmaceutical Form: Tablet INN or Proposed INN: CLOBAZAM CAS Number: 22316478 Other descriptive name: Clobazam PhEur Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Trade Name: Clobazam Product Name: Clobazam Tablets Product Code: Clobazam Tablets 10mg Pharmaceutical Form: Tablet INN or Proposed INN: Clobazam CAS Number: 22316478 Other descriptive name: Clobazam PhEur Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Trade Name: Clobazam Product Name: Clobazam Tablets Product Code: Clobazam Tablets 20mg Pharmaceutical Form: Tablet INN or Proposed INN: Clobazam CAS Number: 22316478 Other descriptive name: Clobazam Pheur Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- | Lundbeck Inc | Not Recruiting | Female: yes Male: yes | 304 | Bulgaria;Lithuania | |||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 36 | NCT00518713 | August 2007 | 19 October 2017 | 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 | Not recruiting | 2 Years | 60 Years | All | 238 | Phase 3 | United States;Australia;Belarus;India;Lithuania;Serbia | |
| 37 | NCT01160770 | December 2005 | 19 October 2017 | 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 | Not recruiting | 2 Years | 60 Years | All | 267 | Phase 3 | ||
| 38 | NCT00162981 | October 2005 | 19 October 2017 | 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 | Not recruiting | 2 Years | 30 Years | All | 68 | Phase 2 | United States | |
| 39 | NCT00297349 | November 2003 | 19 February 2015 | 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 | Not recruiting | 2 Years | N/A | Both | 153 | N/A | ||
| 40 | NCT00004776 | November 1993 | 19 February 2015 | 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 | Not recruiting | 4 Years | 30 Years | Both | 10 | Phase 3 | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 41 | NCT00236756 | August 1993 | 19 February 2015 | 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. | Not recruiting | 12 Months | 30 Years | Both | 100 | Phase 3 |