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Trial Profile

A Phase 3, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of AMZ002, Compared to Vigabatrin, in the Treatment of Infantile Spasms

Status: Withdrawn prior to enrolment

Phase of Trial: Phase III

Latest Information Update: 13 Aug 2023

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At a glance

Drugs AMZ 002 (Primary) ; Vigabatrin
Indications Infantile spasms
Focus Registrational; Therapeutic Use
Sponsors Amzell

Most Recent Events

18 Apr 2023 Planned initiation date changed from 1 Mar 2023 to 1 Apr 2023.
18 Apr 2023 Status changed from recruiting to withdrawn prior to enrolment.
03 Mar 2023 Planned initiation date changed from 31 Jan 2023 to 1 Mar 2023.

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