Trials Sponsors Conditions Drugs Pricing

Conditions

Keywords

AMZ002VigabatrinSeizuresElectroencephalogramsInfantile spasmsWest syndromeCentral Nervous System DiseasesEpileptic Syndrome

Outcome Measures

Primary Outcomes (2)

Proportion of Participants with Absence of Clinical Spasms as Assessed by Video Electroencephalogram (EEG) at Day 14
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
At Day 14

Secondary Outcomes (4)

Time from Treatment Initiation to Absence of Clinical Spasms as Assessed by Parent/Guardian Diary
Baseline up to Day 58
Proportion of Participants with Absence of Clinical Spasms as Assessed by Parent/Guardian Diary at Day 14
At Day 14
Proportion of Participants with Recurrence of Clinical Spasms After Initial Response as Assessed by Video EEG/ by Parent/Guardian Diary
From Day 14 up to Day 58
Time from Initial Response to Recurrence of Clinical Spasms
From Day 14 up to Day 58

Study Arms (2)

AMZ002

EXPERIMENTAL

Drug: AMZ002 injectable solution, 0.5mg/mL

Vigabatrin

ACTIVE COMPARATOR

Drug: Vigabatrin, oral

Interventions

AMZ002 injectable solution, 0.5mg/mLDrug

Injectable solution

AMZ002

Vigabatrin, oralDrug

Oral administration

Vigabatrin

Eligibility Criteria

Age2 Months - 24 Months

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Participant has been diagnosed with IS within 6 weeks prior to Screening. Diagnostic criteria include both clinical spasms and an EEG pattern consistent with hypsarrhythmia or significant abnormality compatible with IS
Participant has normal renal function as defined by an estimated glomerular filtration rate (eGFR) greater than \[\>\] 60 milliliter/minute (mL/min)/1.73 m\^2, calculated as eGFR = 0.413 × (height \[Centimeter (cm)\]/serum creatinine \[milligrams per deciliter {mg/dL}\])

Sponsors & Collaborators

Amzell
Industrylead

Study Sites (41)

The Childrens Hospital Colorado

Aurora, Colorado, 80045-7106, United States

Miami Children's Hospital

Miami, Florida, 33155, United States

Advent Health Orlando

Orlando, Florida, 32803, United States

Arnold Palmer Hospital For Children

Orlando, Florida, 32806, United States

Childrens Healthcare of Atlanta

Atlanta, Georgia, 30329, United States

Ann and Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

University of Kentucky Hospital

Lexington, Kentucky, 40536, United States

MeSH Terms

Conditions

Spasms, InfantileSeizuresCentral Nervous System DiseasesEpileptic Syndromes

Interventions

Vigabatrin

Condition Hierarchy (Ancestors)

Epilepsy, GeneralizedEpilepsyBrain DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid

Enrollment

0 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 9, 2021

First Posted

November 22, 2021

Study Start

April 2023

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (2)

AMZ002

Vigabatrin

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (41)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (2)

AMZ002

Vigabatrin

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (41)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations