A Study to Evaluate the Efficacy, Safety and Tolerability of Oral AK0901 in Children With ADHD

Summary

This study is a Phase 3, multicenter, dose-optimized, double-blind, randomized, placebo-controlled study designed to evaluate the efficacy, safety, and tolerability of oral AK0901 capsules in children 6 to 12 years old with Attention Deficit Hyperactivity Disorder（ADHD）.

Timeline

Start

2024-05-28

Primary completion

2025-01-06

Completion

2025-01-11

Outcome

Met primary endpoint

release “爱智达™（AK0901）在中国的Ⅲ期临床研究由首都医科大学附属北京安定医院和北京大学第六医院共同牵头全国8家临床试验中心开展，旨在评估6~12岁ADHD儿童受试者口服爱智达™的有效性、安全性和耐受性。研究结果显示达到主要终点和关键次要终点” arkbiosciences.com ↗

release “与安慰剂相比在所有访视点上均取得了具有统计学意义的显著改善” arkbiosciences.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AK0901	Unknown	13.1 mg	Oral
Subject	AK0901	Unknown	26.1 mg	Oral
Subject	AK0901	Unknown	39.2 mg	Oral

Indications