Perampanel (DrugBank: Perampanel)
3 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 | 6 |
| 6 | パーキンソン病 | 4 |
| 144 | レノックス・ガストー症候群 | 8 |
| 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 | NCT03793868 (ClinicalTrials.gov) | December 4, 2018 | 28/12/2018 | Perampanel Single Ascending Dose Transcranial Magnetic Stimulation Biomarker Study in Amyotrophic Lateral Sclerosis | Perampanel Single Ascending Dose Transcranial Magnetic Stimulation Biomarker Study in Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: Perampanel;Other: Placebo | Mayo Clinic | NULL | Completed | 18 Years | 70 Years | All | 22 | Early Phase 1 | United States |
| 2 | NCT03377309 (ClinicalTrials.gov) | December 1, 2017 | 14/12/2017 | Safety and Tolerability of Perampanel in Amyotrophic Lateral Sclerosis Patients | Safety and Tolerability of Perampanel in Amyotrophic Lateral Sclerosis Patients | Amyotrophic Lateral Sclerosis | Drug: Fycompa | American University of Beirut Medical Center | NULL | Recruiting | 18 Years | 80 Years | All | 20 | Phase 2 | Lebanon |
| 3 | NCT03019419 (ClinicalTrials.gov) | April 24, 2017 | 10/1/2017 | Perampanel for Sporadic Amyotrophic Lateral Sclerosis (ALS) | Perampanel for Sporadic Amyotrophic Lateral Sclerosis (ALS): A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Trials | ALS | Drug: Perampanel;Drug: placebo | Tokyo Medical University | NULL | Active, not recruiting | 40 Years | 78 Years | All | 60 | Phase 2 | Japan |
| 4 | JPRN-UMIN000025614 | 2017/04/24 | 01/02/2017 | Perampanel for sporadic amyotrophic lateral sclerosis (ALS): A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Trial | Perampanel for sporadic amyotrophic lateral sclerosis (ALS): A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Trial - Perampanel for sporadic amyotrophic lateral sclerosis (ALS) | Sporadic amyotrophic lateral sclerosis | Once daily perampanel with dose-escalation tolerable from 2mg to 4mg for 48 weeks (Interventions) Once daily perampanel with dose-escalation tolerable from 2mg to 8mg for 48 weeks (Interventions). Once daily placebo for 48 weeks (Control) | Department of Neurology, Tokyo Medical University | NULL | Complete: follow-up continuing | 40years-old | 78years-old | Male and Female | 60 | Phase 2 | Japan |
| 5 | JPRN-UMIN000026221 | 2017/03/02 | 01/03/2017 | Safety of perampanel in patients with motor neuron disease | amyotrophic lateral sclerosis | Once daily perampanel with dose escalation from 2mg to 8mg. | Department of Neurology, Juntendo University School of Medicine | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 15 | Phase 1 | Japan | |
| 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 | NCT03020797 (ClinicalTrials.gov) | December 2016 | 15/12/2016 | A Clinical Trial to Evaluate the Safety and Efficacy of Fycompa in Subjects With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: Perampanel;Drug: Placebo Oral Tablet | Stony Brook University | Eisai Inc. | Unknown status | 18 Years | 80 Years | All | 60 | N/A | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT00566462 (ClinicalTrials.gov) | October 2007 | 29/11/2007 | Assessment of Perampanel (E2007) on Synaptic Dopamine in Mild-moderate PD Patients: A Pilot Study With [^123I]-IBZM SPECT | Assessment of Perampanel (E2007) on Synaptic Dopamine in Mild-moderate PD Patients: A Pilot Study With [^123I]-IBZM SPECT | Parkinson's Disease | Drug: perampanel;Drug: placebo | Eisai Inc. | NULL | Terminated | 30 Years | N/A | All | 1 | Phase 2 | United States |
| 2 | NCT00505622 (ClinicalTrials.gov) | July 2007 | 9/7/2007 | Evaluation of the Long-term Safety, Tolerability, and Efficacy of Perampanel (E2007) as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects With Motor Fluctuations | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Perampanel (E2007) as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects With Motor Fluctuations | Parkinson's Disease | Drug: Perampanel | Eisai Limited | NULL | Terminated | 30 Years | N/A | All | 328 | Phase 3 | France |
| 3 | NCT00368108 (ClinicalTrials.gov) | August 2006 | 22/8/2006 | Efficacy, Safety, and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations | A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy, Safety, and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations | Parkinson's Disease | Drug: 2 mg perampanel;Drug: 4 mg perampanel;Drug: placebo comparator | Eisai Inc. | NULL | Completed | 30 Years | N/A | All | 752 | Phase 3 | United States;Canada |
| 4 | NCT01634360 (ClinicalTrials.gov) | November 2004 | 3/7/2012 | Long-Term Safety, Tolerability and Efficacy in Perampanel Treated Parkinson's Disease Patients With Motor Fluctuations | A 48-month Open Label Multi-centered Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 in Patients With Parkinson's Disease With Wearing Off Motor Fluctuations and on Period Dyskinesias | Parkinson's Disease | Drug: Perampanel | Eisai Inc. | NULL | Terminated | N/A | N/A | All | 185 | Phase 2 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 |