Case Study
ACM Global Laboratories was approached to be a central lab for a Phase 3 clinical trial of a new therapy for primary generalized tonic-clonic seizures (PGTCS). The primary study objective was to demonstrate the efficacy of the new treatment vs. a placebo as adjunctive therapy for uncontrolled PGTCS, with the secondary objective being the assessment of the safety and tolerability of the treatment in subjects with idiopathic generalized epilepsy (IGE) with uncontrolled PGTCS.
In this case study, we will explore ACM's successful support of a Phase 3 Clinical Trial for PGTCS Seizure Disorder Treatment through Custom Programming and Safety Protocol Management.®.
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