NCT06359899

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

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Investigate the Efficacy, Safety and Tolerability of Oral Administered AK0901 Capsules in Children Aged 6-12 Years Old With Attention Deficit Hyperactivity Disorder

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Shanghai Ark Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

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）.

Detailed description

The study consists of an approximately 28-day screening period, a 28-day double-blind treatment period, and a follow-up period for 5±2 days. During the screening period, all subjects must sign an informed consent form and complete all assessment items at the screening visit prior to the screening. Study drug is started within 28 days of signing the informed consent form. During the double-blind treatment period, all eligible subjects are randomized 1:1 to receive AK0901 or placebo once daily for 4 weeks. During the first week, all subjects are given a starting dose of 39.2 mg/7.8 mg AK0901 or matching placebo; from the second week, the dose drug can be increased or decreased, or maintained at the original dose level at weekly follow-up depending on tolerability and optimal individual dose response at the investigator's discretion. After the last dose in the double-blind treatment period, subjects will enter a 5 ± 2 day follow-up period for safety assessments. The primary analysis will be performed after all subjects have completed the study.

Conditions

• ADHD

Interventions

Type	Name	Description
DRUG	AK0901 capsule	Active Substance: AK0901, Pharmaceutical Form: Capsule, Route of Administration: Oral
DRUG	Placebo	Active Substance: Placebo, Pharmaceutical Form: Capsule, Route of Administration: Oral

Timeline

• Start date: 2024-05-01
• Primary completion: 2024-09-01
• Completion: 2024-10-01
• First posted: 2024-04-11
• Last updated: 2024-04-11

Locations

2 sites across 1 country: China

Regulatory

• FDA-regulated drug study