Aevi Genomic Medicine Provides Update on Sample Size Re-estimation for Phase 2 ASCEND Trial in ADHD
The decision to increase the sample size was made according to the protocol defined sample size re-estimatation design, which allows an adjustment in the sample size after an interim analysis of the placebo arm to ensure the trial is appropriately powered. As a result of the interim analysis performed by an independent unblinded statistician, the sample size will be increased from 42 to 64 patients.
"The prespecified, interim analysis and sample size re-estimation was planned as part of the study, allowing us to evaluate the placebo effect," said
ASCEND is an adaptive, 6-week, double-blind parallel-group study in children and adolescents (ages 6-17 years) with ADHD with and without copy number variants (CNVs) in specific genes implicated in glutamatergic signaling and neuronal connectivity. Part A includes subjects determined to have one of 8 specific gene mutation(s) implicated in glutamatergic signaling and neuronal connectivity. Part B will assess subjects who do not have CNVs in any of the specific gene mutation(s) implicated in glutamatergic signaling and neuronal connectivity. Once subjects are confirmed as eligible for each part of the study, they are randomized to one of two treatment groups (AEVI-001 or placebo) in a 1:1 ratio.
AEVI-001 is an oral non-stimulant pan selective activator/modulator of mGluRs. The molecule has excellent pharmacokinetic and metabolic profiles and crosses the blood brain barrier.
AEVI-001 is an investigational agent that has not been approved by the US FDA or any other regulatory agencies.
About Aevi Genomic Medicine, Inc.
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Aevi Genomic Medicine, Inc., Brian Piper, Brian.Piper@aevigenomics.com; Westwicke Partners, Chris Brinzey, +1-339-970-2843, Chris.firstname.lastname@example.org; MEDIA INQUIRIES: FTI Consulting, Irma Gomez-Dib, +1-212-850-5761, +1-415-706-9155, http://email@example.com