The main purpose of this study is to evaluate the efficacy of AMZ002 compared to Vigabatrin in participants with newly diagnosed infantile spasms (IS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Injectable solution
Oral administration
Proportion of Participants with Absence of Clinical Spasms as Assessed by Video Electroencephalogram (EEG) at Day 14
Time frame: 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
Time frame: At Day 14
Time from Treatment Initiation to Absence of Clinical Spasms as Assessed by Parent/Guardian Diary
Time frame: Baseline up to Day 58
Proportion of Participants with Absence of Clinical Spasms as Assessed by Parent/Guardian Diary at Day 14
Time frame: At Day 14
Proportion of Participants with Recurrence of Clinical Spasms After Initial Response as Assessed by Video EEG/ by Parent/Guardian Diary
Time frame: From Day 14 up to Day 58
Time from Initial Response to Recurrence of Clinical Spasms
Time frame: From Day 14 up to Day 58
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