AMZ002 ( DrugBank: AMZ002 )


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2

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
1EUCTR2021-003015-26-ES
(EUCTR)
12/04/202225/10/2021Treatment of Infantile SpasmsA Phase 3, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of AMZ002, Compared to Vigabatrin, in the Treatment of Infantile Spasms Monotherapy for the treatment of infantile spasms (IS) in infants and children2 months to 24 months of age
MedDRA version: 21.1;Level: PT;Classification code 10021750;Term: Infantile spasms;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Level: LLT;Classification code 10021751;Term: Infantile spasms, with intractable epilepsy;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10021752;Term: Infantile spasms, without mention of intractable epilepsy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AMZ002
Product Code: AMZ002
INN or Proposed INN: Vigabatrin
Trade Name: Sabril
Product Name: Sabril
Product Code: Vigabatrin
INN or Proposed INN: Vigabatrin
Amzell B.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
230Phase 3France;United States;Poland;Spain
2EUCTR2021-003015-26-FR
(EUCTR)
31/12/2021Treatment of Infantile SpasmsA Phase 3, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of AMZ002, Compared to Vigabatrin, in the Treatment of Infantile Spasms Monotherapy for the treatment of infantile spasms (IS) in infants and children2 months to 24 months of age
MedDRA version: 21.1;Level: PT;Classification code 10021750;Term: Infantile spasms;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Level: LLT;Classification code 10021751;Term: Infantile spasms, with intractable epilepsy;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10021752;Term: Infantile spasms, without mention of intractable epilepsy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AMZ002
Product Code: AMZ002
INN or Proposed INN: Vigabatrin
Trade Name: Sabril
Product Name: Sabril
Product Code: Vigabatrin
INN or Proposed INN: Vigabatrin
Amzell B.V.NULLNAFemale: yes
Male: yes
230Phase 3United States;France;Spain;Poland;Germany