UCB3491 ( 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5

145. ウエスト症候群


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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-002107-26-BG
(EUCTR)
10/11/201705/07/2017A 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 SPRLNULLNot RecruitingFemale: yes
Male: yes
60Phase 2France;Belgium;Bulgaria;Germany;United Kingdom
2EUCTR2016-002107-26-DE
(EUCTR)
21/08/201725/04/2017A 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 SPRLNULLNot 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): noFrance;Belgium;Bulgaria;Germany;United Kingdom
3EUCTR2016-002107-26-FR
(EUCTR)
09/06/201710/07/2017A 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 SPRLNULLNot 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): noFrance;Belgium;Bulgaria;Germany;United Kingdom
4EUCTR2016-002107-26-BE
(EUCTR)
30/11/201626/09/2016A 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 SPRLNULLNot RecruitingFemale: yes
Male: yes
60Phase 2France;Belgium;Bulgaria;Germany;United Kingdom
5EUCTR2016-002107-26-GB
(EUCTR)
24/10/201612/08/2016A 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 SPRLNULLNot RecruitingFemale: yes
Male: yes
60Phase 2France;Belgium;Bulgaria;Germany;United Kingdom