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

> **NCT05128344** · PHASE3 · WITHDRAWN · sponsor: **Amzell**

## Conditions studied

- Spasms, Infantile

## Interventions

- **DRUG:** AMZ002 injectable solution, 0.5mg/mL
- **DRUG:** Vigabatrin, oral

## Key facts

- **NCT ID:** NCT05128344
- **Lead sponsor:** Amzell
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** WITHDRAWN
- **Start date:** 2023-04
- **Primary completion:** 2025-06
- **Final completion:** 2025-12
- **Target enrollment:** 0 (ACTUAL)
- **Why stopped:** Strategic decision
- **Last updated:** 2023-04-20


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05128344

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05128344, "A Study to Evaluate Safety and Efficacy of AMZ002 Treatment, Compared With Vigabatrin in Participants With Infantile Spasms". Retrieved via AI Analytics 2026-07-20 from https://api.ai-analytics.org/clinical/NCT05128344. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*