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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 from day 14 up to day 58
Awards & highlights

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 ~from day 14 up to day 58
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 14 up to day 58 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of Participants with Absence of Clinical Spasms as Assessed by Video Electroencephalogram (EEG) at Day 14
Proportion of Participants with Resolution of Hypsarrhythmia or Significant Abnormality Compatible with Infantile Spasms (IS) as Assessed by Video EEG at Day 14
Secondary outcome measures
Proportion of Participants with Absence of Clinical Spasms as Assessed by Parent/Guardian Diary at Day 14
Proportion of Participants with Recurrence of Clinical Spasms After Initial Response as Assessed by Video EEG/ by Parent/Guardian Diary
Time from Initial Response to Recurrence of Clinical Spasms
+1 more

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
2 Previous Clinical Trials
518 Total Patients Enrolled
~0 spots leftby Jun 2025
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