AMZ002 / Amzell, Ferring, Nordic Group - LARVOL DELTA

A Study to Evaluate Safety and Efficacy of AMZ002 Treatment, Compared With Vigabatrin in Participants With Infantile Spasms (clinicaltrials.gov) - P3 | N=0 | Withdrawn | Sponsor: Amzell | N=150 ➔ 0 | Recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • CNS Disorders • Epilepsy

A Study to Evaluate Safety and Efficacy of AMZ002 Treatment, Compared With Vigabatrin in Participants With Infantile Spasms (clinicaltrials.gov) - P3 | N=150 | Recruiting | Sponsor: Amzell | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Epilepsy

A Study to Evaluate Safety and Efficacy of AMZ002 Treatment, Compared With Vigabatrin in Participants With Infantile Spasms (clinicaltrials.gov) - P3 | N=150 | Not yet recruiting | Sponsor: Amzell | Trial completion date: Jan 2025 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Jun 2025

Trial completion date • Trial primary completion date • CNS Disorders

A Study to Evaluate Safety and Efficacy of AMZ002 Treatment, Compared With Vigabatrin in Participants With Infantile Spasms (clinicaltrials.gov) - P3 | N=150 | Not yet recruiting | Sponsor: Amzell | Trial completion date: Sep 2024 ➔ Jan 2025 | Initiation date: Apr 2022 ➔ Sep 2022 | Trial primary completion date: Jun 2024 ➔ Dec 2024

Trial completion date • Trial initiation date • Trial primary completion date • CNS Disorders

A Study to Evaluate Safety and Efficacy of AMZ002 Treatment, Compared With Vigabatrin in Participants With Infantile Spasms (clinicaltrials.gov) - P3 | N=150 | Not yet recruiting | Sponsor: Amzell | Trial completion date: Jul 2023 ➔ Sep 2024 | Trial primary completion date: Jun 2023 ➔ Jun 2024

Trial completion date • Trial primary completion date • CNS Disorders

Amzell B.V. and Amring Pharmaceuticals Inc. Attending 2021 American Epilepsy Society Meeting in Chicago (Businesswire) - "Amzell B.V...and Amring Pharmaceuticals Inc...announced today that they will be in attendance at the 2021 American Epilepsy Society (AES) Annual Meeting. The meeting will be held from Dec 3 to Dec 7, 2021, at McCormick Place West in Chicago, IL. Amzell and Amring will be in attendance to discuss the upcoming U.S. Phase III Clinical Trial for the treatment of Infantile Epileptic Disease."

Clinical • CNS Disorders • Epilepsy

Amzell, B.V., in Collaboration With Amring Pharmaceuticals Inc. Announce Their Lead Product Has Entered Phase III Clinical Trial in the U.S. for Treatment of Infantile Epileptic Disease (Businesswire) - "Amzell, B.V...announced today that their lead product in the collaboration, AMZ002, has entered Phase III Clinical Trial in the U.S. for treatment of infantile epileptic disease....'We are pleased that the Phase III program is underway, and that our collaboration with Amzell will produce significant benefits for young children and their parents in the U.S. and globally...'"

Trial status • CNS Disorders • Epilepsy

A Study to Evaluate Safety and Efficacy of AMZ002 Treatment, Compared With Vigabatrin in Participants With Infantile Spasms (clinicaltrials.gov) - P3; N=150; Not yet recruiting; Sponsor: Amzell

Clinical • New P3 trial • CNS Disorders