Evaluate Safety and Efficacy of ORADUR®-Methylphenidate in Children and Adolescents With ADHD

Phase 3

Completed

• Conditions: Attention Deficit Hyperactivity Disorder
• Interventions: Drug: ORADUR® First, then Placebo; Drug: Placebo First, then ORADUR®

• Registration Number: NCT02450890
• Lead Sponsor: Orient Pharma Co., Ltd.

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of ORADUR®-Methylphenidate in children and adolescents with ADHD.

Detailed Description

This Phase III, multi-center, randomized, double-blind, placebo controlled, two-way cross-over study aims to observe the efficacy and safety of ORADUR®-Methylphenidate in children and adolescents with ADHD age 6 to 18 years old.

The study is comprised of four main phases: a screening period lasting about 14 days, an open-label titration period lasting 2 to 4 weeks, a double-blind and placebo controlled two-way cross-over study period of 4 weeks (2 weeks for Period 1 and 2 weeks for Period 2), then a follow-up phase of 2 weeks. Screening baseline is defined as Day 0 (Visit 2).

At the last day of the titration period (Day 14 for 22 mg, Day 21 for 33 mg group, and Day 28 for 44 mg group), subjects will be randomly assigned to receive ORADUR®-Methylphenidate at their optimal dose or placebo at a 1:1 ratio according to the randomization scheme during each study period (Period 1 and Period 2) at treatment phase; no washout period will be included between two treatment periods.

Study Timeline

• Study First Submitted: 2015-05-19
• Study First Submitted QC: 2015-05-20
• Study First Posted: 2015-05-21
• Study Start: 2015-06
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-30
• Last Update Posted: 2021-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ORADUR® First, then Placebo	ORADUR® First, then Placebo	ORADUR®-Methylphenidate oral capsule at the optimal dose once daily for 2 weeks in Period 1 and Placebo once daily for 2 weeks in period 2. (No washout period between two treatment periods)
Placebo First, then ORADUR®	Placebo First, then ORADUR®	Placebo once daily for 2 weeks in Period 1 and ORADUR®-Methylphenidate oral capsule at the optimal dose once daily for 2 weeks in period 2. (No washout period between two treatment periods)

Primary Outcome Measures

Name	Time	Method
SNAP-IV teacher form score in ORADUR®-Methylphenidate vs. placebo	2 weeks	To determine the Swanson, Nolan, and Pelham-IV (SNAP-IV) teacher form score of children and adolescents with ADHD who are administered ORADUR®-Methylphenidate versus those who are administered placebo

Secondary Outcome Measures

Name	Time	Method
Diagnostic & Statistical Manual for Mental Disorders-Fifth Edition (DSM-5) diagnosis in ORADUR®-Methylphenidate vs. placebo	2 to 4 weeks	To determine the Diagnostic \& Statistical Manual for Mental Disorders-Fifth Edition (DSM-5) diagnosis of children and adolescents with ADHD who are administered ORADUR®-Methylphenidate versus those who are administered placebo.
Clinical Global Impression-ADHD-Severity (CGI-S) score in ORADUR®-Methylphenidate vs. placebo	2 weeks	To determine the Clinical Global Impression-ADHD-Severity (CGI-S) score of children and adolescents with ADHD who are administered ORADUR®-Methylphenidate versus those who are administered placebo.
SNAP-IV parent form score in ORADUR®-Methylphenidate (open titration period)	2 weeks	To examine changes of the Swanson, Nolan, and Pelham-IV (SNAP-IV) parent form scores in children and adolescents with ADHD administered ORADUR®-Methylphenidate at different dose schedules in the titration period.
SNAP-IV parent form score in ORADUR®-Methylphenidate vs. placebo	2 weeks	To determine the Swanson, Nolan, and Pelham-IV (SNAP-IV) parent form score of children and adolescents with ADHD who are administered ORADUR®-Methylphenidate versus those who are administered placebo.
Remission rate in ORADUR®-Methylphenidate vs. placebo	2 weeks	To determine the remission rate of children and adolescents with ADHD who are administered ORADUR®-Methylphenidate versus those who are administered placebo.
Conners' Teacher's Rating Scale score in ORADUR®-Methylphenidate vs. placebo	2 weeks	To determine the Conners' Teacher's Rating Scale score of children and adolescents with ADHD who are administered ORADUR®-Methylphenidate versus those who are administered placebo.
Conners' Continuous Performance Test (CPT-II) performance in ORADUR®-Methylphenidate vs. placebo	2 to 4 weeks	To determine the Conners' Continuous Performance Test (CPT-II) performance of children and adolescents with ADHD who are administered ORADUR®-Methylphenidate versus those who are administered placebo.
Clinical Global Impression-ADHD-Improvement (CGI-I) score in ORADUR®-Methylphenidate vs. placebo	2 weeks	To determine the Clinical Global Impression-ADHD-Improvement (CGI-I) score of children and adolescents with ADHD who are administered ORADUR®-Methylphenidate versus those who are administered placebo.

Trial Locations

Locations (4)

Tri-Service General Hospital; 🇨🇳 Taipei City, Taiwan

Chang Gung Medical Foundation- Chiayi Branch; 🇨🇳 Chiayi City, Taiwan

Chang Gung Medical Foundation- Linkuo Branch; 🇨🇳 Taoyuan, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan