145. ウエスト症候群 West syndrome Clinical trials / Disease details
臨床試験数 : 43 / 薬物数 : 52 - (DrugBank : 15) / 標的遺伝子数 : 28 - 標的パスウェイ数 : 26
| 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 | NCT02829827 (ClinicalTrials.gov) | December 4, 2017 | 8/7/2016 | A Phase 2 Study of Radiprodil in Subjects With Drug-resistant Infantile Spasms (IS) | An Open-label Adaptive Study for the Assessment of Safety, Tolerability, Pharmacokinetics, and Efficacy of Multiple Doses of Radiprodil in Subjects With Drug-resistant Infantile Spasms | Infantile Spasms (IS) | Drug: Radiprodil | UCB Biopharma S.P.R.L. | NULL | Terminated | 2 Months | 14 Months | All | 3 | Phase 2 | France;Belgium;Bulgaria;Germany;United Kingdom |
| 2 | EUCTR2016-002107-26-BG (EUCTR) | 10/11/2017 | 05/07/2017 | A phase 2 study of Radiprodil in subjects with drug-resistant infantile spasms (IS) | AN OPEN-LABEL ADAPTIVE STUDY FOR THE ASSESSMENT OF SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF MULTIPLE DOSES OF RADIPRODIL IN SUBJECTS WITH DRUG-RESISTANT INFANTILE SPASMS | Infantile spasms (IS) MedDRA version: 20.1;Level: PT;Classification code 10021750;Term: Infantile spasms;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Radiprodil Product Code: UCB3491 INN or Proposed INN: Radiprodil | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | France;Belgium;Bulgaria;Germany;United Kingdom | ||
| 3 | EUCTR2016-002107-26-DE (EUCTR) | 21/08/2017 | 25/04/2017 | A phase 2 study of Radiprodil in subjects with drug-resistant infantile spasms (IS) | AN OPEN-LABEL ADAPTIVE STUDY FOR THE ASSESSMENT OF SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF MULTIPLE DOSES OF RADIPRODIL IN SUBJECTS WITH DRUG-RESISTANT INFANTILE SPASMS | Infantile spasms (IS) MedDRA version: 20.1;Level: PT;Classification code 10021750;Term: Infantile spasms;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Radiprodil Product Code: UCB3491 INN or Proposed INN: Radiprodil | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Belgium;Bulgaria;Germany;United Kingdom | ||
| 4 | EUCTR2016-002107-26-FR (EUCTR) | 09/06/2017 | 10/07/2017 | A phase 2 study of Radiprodil in subjects with drug-resistant infantile spasms (IS) | AN OPEN-LABEL ADAPTIVE STUDY FOR THE ASSESSMENT OF SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF MULTIPLE DOSES OF RADIPRODIL IN SUBJECTS WITH DRUG-RESISTANT INFANTILE SPASMS | Infantile spasms (IS) MedDRA version: 20.0;Level: PT;Classification code 10021750;Term: Infantile spasms;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Radiprodil Product Code: UCB3491 INN or Proposed INN: Radiprodil | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Belgium;Bulgaria;Germany;United Kingdom | ||
| 5 | EUCTR2016-002107-26-BE (EUCTR) | 30/11/2016 | 26/09/2016 | A phase 2 study of Radiprodil in subjects with drug-resistant infantile spasms (IS) | AN OPEN-LABEL ADAPTIVE STUDY FOR THE ASSESSMENT OF SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF MULTIPLE DOSES OF RADIPRODIL IN SUBJECTS WITH DRUG-RESISTANT INFANTILE SPASMS | Infantile spasms (IS) MedDRA version: 20.1;Level: PT;Classification code 10021750;Term: Infantile spasms;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Radiprodil Product Code: UCB3491 INN or Proposed INN: Radiprodil | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | France;Belgium;Bulgaria;Germany;United Kingdom | ||
| 6 | EUCTR2016-002107-26-GB (EUCTR) | 24/10/2016 | 12/08/2016 | A phase 2 study of Radiprodil in subjects with drug-resistant infantile spasms (IS) | AN OPEN-LABEL ADAPTIVE STUDY FOR THE ASSESSMENT OF SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF MULTIPLE DOSES OF RADIPRODIL IN SUBJECTS WITH DRUG-RESISTANT INFANTILE SPASMS | Infantile spasms (IS) MedDRA version: 20.1;Level: PT;Classification code 10021750;Term: Infantile spasms;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Radiprodil Product Code: UCB3491 INN or Proposed INN: Radiprodil | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | France;Belgium;Bulgaria;Germany;United Kingdom |