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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

Study Summary

This trial will compare the effectiveness of two drugs for infantile spasms, a rare childhood seizure disorder.

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

Find a Location

Who is running the clinical trial?

AmzellLead Sponsor
2 Previous Clinical Trials
518 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there other drugs in development that are similar to AMZ002?

"As of right now, there are 7 clinical trials underway for AMZ002 injectable solution. Out of those 7 live studies, 2 have reached Phase 3. The majority of the trials taking place for this treatment are located in Birmingham, Alabama; however, 44 different sites across the country are running these types of tests."

Answered by AI

How many people can join this clinical trial at most?

"No, this study is not recruiting patients currently. The original posting date for the trial was September 29th, 2022 and it was last updated on June 13th of the same year. There are 18 other trials actively enrolling participants with nodding spasm and 7 AMZ002 injectable solution, 0.5mg/mL clinical trials that are still looking for volunteers."

Answered by AI

How can I become a participant in this research?

"We are looking for 150 participants, aged 2 months to 24 months, who currently suffer from nodding spasm. It is crucial that potential participants also meet the following prerequisites: eGFR must be greater than 60 mL/min/1.73 m^2 , a diagnosis of IS within 6 weeks prior to screening via clinical spasms and an EEG pattern consistent with hypsarrhythmia or significant abnormality compatible with IS, written informed consent from a legal guardian, understanding and compliance with study procedures by the parent or guardian."

Answered by AI

What is the FDA's stance on AMZ002 injectable solution, 0.5mg/mL?

"The safety of AMZ002 injectable solution, 0.5mg/mL is estimated to be a 3. This assessment is based on the fact that it is a Phase 3 trial, which means that there is both efficacy data and multiple rounds of safety data available."

Answered by AI

In how many medical facilities is this trial being conducted?

"There are a total of 16 enrolling patients for this study, which locations including University of Kentucky Hospital in Lexington, Advent Health Orlando in Portland, OHSU Pediatric Neurology in Atlanta, as well as other sites."

Answered by AI

Will this test be conducted on elderly individuals?

"This clinical trial is only seeking patients that are between 2 and 24 months old. Out of the 12 total clinical trials, this is 1 of the 12 trials meant for infants/toddlers."

Answered by AI

Are there any open slots in this clinical trial for new patients?

"The trial in question, which is no longer recruiting patients as of 6/13/2022, was first posted on 9/29/2022 according to clinicaltrials.gov. There are other ongoing studies that may be seeking patients."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate Safety and Efficacy of AMZ002 Treatment, Compared With Vigabatrin in Participants With Infantile Spasms
2023. "A Study to Evaluate Safety and Efficacy of AMZ002 Treatment, Compared With Vigabatrin in Participants With Infantile Spasms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05128344.
~0 spots leftby Jun 2025
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