A Study to Evaluate Safety and Efficacy of AMZ002 Treatment, Compared With Vigabatrin in Particip… (NCT05128344) | Clinical Trial Compass
WithdrawnPhase 3
A Study to Evaluate Safety and Efficacy of AMZ002 Treatment, Compared With Vigabatrin in Participants With Infantile Spasms
Stopped: Strategic decision
United States0Started 2023-04
Plain-language summary
The main purpose of this study is to evaluate the efficacy of AMZ002 compared to Vigabatrin in participants with newly diagnosed infantile spasms (IS).
Who can participate
Age range2 Months – 24 Months
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Ă— (height \[Centimeter (cm)\]/serum creatinine \[milligrams per deciliter {mg/dL}\])
* Participant's legally authorized representative (that is \[i.e.\], parent or guardian) must provide written informed consent obtained per Institutional Review Board (IRB) policy and requirements, consistent with the International Council for Harmonisation (ICH)
* Participant's parent/guardian is able to understand and willing to comply with study procedures and restrictions
Exclusion Criteria:
* Participant has been diagnosed with tuberous sclerosis
* Participant has acute illness considered clinically significant by the Investigator within 30 days prior to Screening
* Participant has a diagnosis of recent systemic fungal infection; history of ocular herpes simplex; history of or current peptic ulcer; uncontrolled hypertension or congestive heart failure; or any other condition that would be significantly impacted by the study drug
* Participant has a preplanned surgery or procedure(s) that would interfere with the conduct of the study
* Participant has received any…
What they're measuring
1
Proportion of Participants with Absence of Clinical Spasms as Assessed by Video Electroencephalogram (EEG) at Day 14
Timeframe: At Day 14
2
Proportion of Participants with Resolution of Hypsarrhythmia or Significant Abnormality Compatible with Infantile Spasms (IS) as Assessed by Video EEG at Day 14