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AMZ002 vs Vigabatrin in Infantile Spasms
NCT05128344Phase 3Withdrawn
- Sponsor
- Amzell B.V.
- Start
- Apr 2023
- Primary completion
- Jun 2025
- Modality
- Peptides, Recombinant Proteins and Enzymes, Small Molecules
- Countries
- 8
01
Overview
Phase 3, randomised, open-label trial of AMZ002 in infantile epileptic spasms syndrome (IESS) (2 arms), sponsored by Amzell B.V. Primary endpoints: Proportion of Participants with Absence of Clinical Spasms as Assessed by Video EEG at Day 14 and Proportion of Participants with Resolution of Hypsarrhythmia or Significant Abnormality Compatible with Infantile Spasms at Day 14. Planned start Apr 2023; status: withdrawn.
02
Drugs
AMZ002
03
Conditions
infantile epileptic spasms syndrome (IESS)
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