Fycompa ( DrugBank: - )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
2筋萎縮性側索硬化症2
144レノックス・ガストー症候群7

2. 筋萎縮性側索硬化症


臨床試験数 : 624 薬物数 : 611 - (DrugBank : 160) / 標的遺伝子数 : 172 - 標的パスウェイ数 : 225
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03377309
(ClinicalTrials.gov)
December 1, 201914/12/2017Safety and Tolerability of Perampanel in Amyotrophic Lateral Sclerosis PatientsSafety and Tolerability of Perampanel in Amyotrophic Lateral Sclerosis PatientsAmyotrophic Lateral SclerosisDrug: FycompaAmerican University of Beirut Medical CenterNULLTerminated18 Years80 YearsAll6Phase 2Lebanon
2NCT03020797
(ClinicalTrials.gov)
January 12, 201715/12/2016A Clinical Trial to Evaluate the Safety and Efficacy of Fycompa in Subjects With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: Perampanel;Drug: Placebo Oral TabletStony Brook UniversityEisai Inc.Recruiting18 Years80 YearsAll60N/AUnited States

144. レノックス・ガストー症候群


臨床試験数 : 101 薬物数 : 68 - (DrugBank : 12) / 標的遺伝子数 : 49 - 標的パスウェイ数 : 60
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2014-002321-35-BE
(EUCTR)
05/06/201825/04/2017A global study completed at hospitals in US, Europe & Asia using an investigational drug (Perampanel) to research its safety & effectiveness in patients who are at least 2 years of age with Lennox-Gastaut SyndromeA Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial With an Open-Label Extension Phase of Perampanel as Adjunctive Treatment in Subjects at Least 2 years of Age With Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome Seizures associated with Lennox-Gastaut Syndrome (LGS)
MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Fycompa
Product Name: perampanel
Product Code: E2007
INN or Proposed INN: perampanel
Other descriptive name: PERAMPANEL
Trade Name: Fycompa
Product Name: perampanel
Product Code: E2007
INN or Proposed INN: Perampanel
Other descriptive name: PERAMPANEL
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
142Phase 3United States;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Latvia;Japan;Italy;Korea, Republic of
2EUCTR2014-002321-35-IT
(EUCTR)
01/09/201720/01/2022A global study completed at hospitals in US, Europe & Asia using an investigational drug (Perampanel) to research its safety & effectiveness inpatients who are at least 2 years of age with Lennox-Gastaut SyndromeA Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial With anOpen-Label Extension Phase of Perampanel as Adjunctive Treatment inSubjects at Least 2 years of Age With Inadequately Controlled SeizuresAssociated With Lennox-Gastaut Syndrome - - Seizures associated with Lennox-Gastaut Syndrome (LGS)
MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Fycompa
INN or Proposed INN: PERAMPANEL
Other descriptive name: PERAMPANEL
Trade Name: Fycompa
INN or Proposed INN: PERAMPANEL
Other descriptive name: PERAMPANEL
EISAI LIMITEDNULLNot RecruitingFemale: yes
Male: yes
142Phase 3United States;Czechia;Korea, Democratic People's Republic of;Lithuania;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Latvia;Japan;Korea, Republic of
3EUCTR2014-002321-35-CZ
(EUCTR)
31/08/201726/05/2017A global study completed at hospitals in US, Europe & Asia using an investigational drug (Perampanel) to research its safety & effectiveness in patients who are at least 2 years of age with Lennox-Gastaut SyndromeA Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial With an Open-Label Extension Phase of Perampanel as Adjunctive Treatment in Subjects at Least 2 years of Age With Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome Seizures associated with Lennox-Gastaut Syndrome (LGS)
MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Fycompa
Product Name: perampanel
Product Code: E2007
INN or Proposed INN: perampanel
Other descriptive name: PERAMPANEL
Trade Name: Fycompa
Product Name: perampanel
Product Code: E2007
INN or Proposed INN: Perampanel
Other descriptive name: PERAMPANEL
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
142Phase 3United States;Czechia;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Latvia;Japan;Korea, Republic of
4EUCTR2014-002321-35-LV
(EUCTR)
26/05/201709/05/2017A global study completed at hospitals in US, Europe & Asia using an investigational drug (Perampanel) to research its safety & effectiveness in patients who are at least 2 years of age with Lennox-Gastaut SyndromeA Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial With an Open-Label Extension Phase of Perampanel as Adjunctive Treatment in Subjects at Least 2 years of Age With Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome Seizures associated with Lennox-Gastaut Syndrome (LGS)
MedDRA version: 20.0;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Fycompa
Product Name: perampanel
Product Code: E2007
INN or Proposed INN: perampanel
Other descriptive name: PERAMPANEL
Trade Name: Fycompa
Product Name: perampanel
Product Code: E2007
INN or Proposed INN: Perampanel
Other descriptive name: PERAMPANEL
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
142Phase 3France;United States;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Latvia;Japan;Italy;Korea, Republic of
5EUCTR2014-002321-35-HU
(EUCTR)
08/05/201720/04/2017A global study completed at hospitals in US, Europe & Asia using an investigational drug (Perampanel) to research its safety & effectiveness in patients who are at least 2 years of age with Lennox-Gastaut SyndromeA Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial With an Open-Label Extension Phase of Perampanel as Adjunctive Treatment in Subjects at Least 2 years of Age With Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome Seizures associated with Lennox-Gastaut Syndrome (LGS)
MedDRA version: 19.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Fycompa
Product Name: perampanel
Product Code: E2007
INN or Proposed INN: perampanel
Other descriptive name: PERAMPANEL
Trade Name: Fycompa
Product Name: perampanel
Product Code: E2007
INN or Proposed INN: Perampanel
Other descriptive name: PERAMPANEL
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
142Phase 3United States;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Latvia;Japan;Italy;Korea, Republic of
6EUCTR2014-002321-35-PL
(EUCTR)
13/05/2017A global study completed at hospitals in US, Europe & Asia using an investigational drug (Perampanel) to research its safety & effectiveness in patients who are at least 2 years of age with Lennox-Gastaut SyndromeA Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial With an Open-Label Extension Phase of Perampanel as Adjunctive Treatment in Subjects at Least 2 years of Age With Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome Seizures associated with Lennox-Gastaut Syndrome (LGS)
MedDRA version: 20.0;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Fycompa
Product Name: perampanel
Product Code: E2007
INN or Proposed INN: perampanel
Other descriptive name: PERAMPANEL
Trade Name: Fycompa
Product Name: perampanel
Product Code: E2007
INN or Proposed INN: Perampanel
Other descriptive name: PERAMPANEL
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
142Phase 3United States;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Latvia;Japan;Italy;Korea, Republic of
7EUCTR2014-002321-35-FR
(EUCTR)
21/02/2018A global study completed at hospitals in US, Europe & Asia using an investigational drug (Perampanel) to research its safety & effectiveness in patients who are at least 2 years of age with Lennox-Gastaut SyndromeA Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial With an Open-Label Extension Phase of Perampanel as Adjunctive Treatment in Subjects at Least 2 years of Age With Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome Seizures associated with Lennox-Gastaut Syndrome (LGS)
MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Fycompa
Product Name: perampanel
Product Code: E2007
INN or Proposed INN: perampanel
Other descriptive name: PERAMPANEL
Trade Name: Fycompa
Product Name: perampanel
Product Code: E2007
INN or Proposed INN: Perampanel
Other descriptive name: PERAMPANEL
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
142Phase 3United States;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Latvia;Japan;Italy;Korea, Republic of