drugset / Trial / NCT05286762

Phase 3 Efficacy and Safety Fixed-Dose Study in Pediatrics (6-17) With ADHD Using CTx-1301

NCT05286762 ↗

Phase 3 Completed 103 enrolled Cingulate Therapeutics
RandomizedParallel-groupQuadruple-blindTreatment

Summary

A Phase 3, randomized, double-blind, placebo-controlled, multi-center, fixed-dose, parallel-group efficacy and safety study in a pediatric population (6-17) with Attention-Deficit/Hyperactivity Disorder (ADHD) using CTx-1301 (d-MPH). The study will be comprised of a screening period, a double-blind randomized phase, and a safety follow-up visit.

Timeline

Start
2023-08-01
Primary completion
2024-02-29
Completion
2024-02-29

Drugs

EvaluationDrugModalityDoseRoute
Comparator CTx-1301 Unknown 18.75 mg —
Comparator CTx-1301 Unknown 25 mg —
Comparator CTx-1301 Unknown 37.5 mg —