Rufinamide oral suspension (DrugBank: Rufinamide)
1 disease| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 144 | レノックス・ガストー症候群 | 4 |
| 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 | 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 | |||
| 2 | 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 | |||
| 3 | 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 | |||
| 4 | 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 |