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AMZ002 injectable solution, 0.5mg/mL for Infantile Spasms

Phase 3
Waitlist Available
Research Sponsored by Amzell
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial is testing a new treatment called AMZ002 to see if it works better than Vigabatrin for babies who have just been diagnosed with infantile spasms. The goal is to find out which treatment can better control or reduce their seizures. Vigabatrin has been used as a treatment for infantile spasms and is considered effective, often compared with hormonal treatments like ACTH.

Eligible Conditions
  • Infantile Spasms

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: AMZ002Experimental Treatment1 Intervention
Group II: VigabatrinActive Control1 Intervention

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Who is running the clinical trial?

AmzellLead Sponsor
3 Previous Clinical Trials
1,058 Total Patients Enrolled
~0 spots leftby Jun 2025
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