AMZ002 ( DrugBank: AMZ002 )
1 disease
| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 145 | West syndrome | 2 |
145. West syndrome
Clinical trials : 43 / Drugs : 52 - (DrugBank : 15) / Drug target genes : 28 - Drug target pathways : 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 | EUCTR2021-003015-26-ES (EUCTR) | 12/04/2022 | 25/10/2021 | Treatment of Infantile Spasms | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 230 | Phase 3 | France;United States;Poland;Spain | ||
| 2 | EUCTR2021-003015-26-FR (EUCTR) | 31/12/2021 | Treatment of Infantile Spasms | A 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. | NULL | NA | Female: yes Male: yes | 230 | Phase 3 | United States;France;Spain;Poland;Germany |