NCT05128344

A Study to Evaluate Safety and Efficacy of AMZ002 Treatment, Compared With Vigabatrin in Participants With 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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Amzell · Industry
• Sex: All
• Age: 2 Months – 24 Months
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to evaluate the efficacy of AMZ002 compared to Vigabatrin in participants with newly diagnosed infantile spasms (IS).

Conditions

• Spasms, Infantile

Interventions

Type	Name	Description
DRUG	AMZ002 injectable solution, 0.5mg/mL	Injectable solution
DRUG	Vigabatrin, oral	Oral administration

Timeline

• Start date: 2023-04-01
• Primary completion: 2025-06-01
• Completion: 2025-12-01
• First posted: 2021-11-22
• Last updated: 2023-04-20

Locations

41 sites across 8 countries: United States, Argentina, France, India, Italy, Mexico, Poland, Spain

Regulatory

• FDA-regulated drug study