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

NCT06359899 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-04-11

No results posted yet for this study

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）.

Conditions

  • ADHD

Interventions

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

Sponsors & Collaborators

  • Shanghai Ark Biopharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jingjing Hu · Clinical Operation Head

  • Jun Qi · Medicial Director

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-31
Primary Completion
2024-09-30
Completion
2024-10-31
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06359899 on ClinicalTrials.gov