M071754 (DrugBank: -)
1 disease告示番号 | 疾患名(ページ内リンク) | 臨床試験数 |
---|---|---|
145 | ウエスト症候群 | 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 |
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1 | JPRN-JapicCTI-142559 | 01/11/2012 | 02/06/2014 | A open-label study of M071754 in patients with infantile spasms | A Long term study of M071754 - A open-label study in patients with infantile spasms - | infantile spasms | Intervention name : M071754 INN of the intervention : vigabatrin Dosage And administration of the intervention : oral | Alfresa Pharma Corporation | Sanofi KK | 0 | 5 | BOTH | Phase 4 | NULL | ||
2 | JPRN-JapicCTI-142558 | 01/8/2012 | A single-blind study of M071754 in patients with infantile spasms | A Phase III study of M071754 - A single-blind study in patients with infantile spasms - | infantile spasms | Intervention name : M071754 INN of the intervention : vigabatrin Dosage And administration of the intervention : oral Control intervention name : null | Alfresa Pharma Corporation | Sanofi KK | 0 | 1 | BOTH | 12 | Phase 3 | NULL | ||
3 | EUCTR2017-000230-62-Outside-EU/EEA (EUCTR) | 24/04/2017 | A single-blind study of M071754 in patients with infantile spasms. | A Phase III study of M071754 - A single-blind study in patients with infantile spasms. - | Patients diagnosed with infantile spasms MedDRA version: 19.1;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: VIGABATRIN Product Code: M071754 INN or Proposed INN: VIGABATRIN | Alfresa Pharma Corporation and Sanofi KK | NULL | NA | Female: yes Male: yes | 12 | Phase 3 | Japan | |||
4 | EUCTR2017-000611-17-Outside-EU/EEA (EUCTR) | 28/08/2017 | A open-label study of M071754 in patients with infantile spasms. | A Long term study of M071754 - A open-label study in patients with infantile spasms. | Patients diagnosed with infantile spasms 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: VIGABATRIN Product Code: M071754 INN or Proposed INN: VIGABATRIN | Alfresa Pharma Corporation and Sanofi KK | NULL | NA | Female: yes Male: yes | 17 | Phase 3 | Japan |