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 | 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 | |||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | |
| 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 | 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 |
| 7 | 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 | ||
| 8 | 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 |