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

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status

Completed

Phase

Phase 3

Locations

Taiwan

Study Type

Interventional

Intervention

Placebo First, then ORADUR®

ORADUR® First, then Placebo

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring ORADUR®-Methylphenidate

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Main inclusion criteria:

Female or male subjects with age between 6 and 18 years old.
Subjects with documented diagnosis of one of the three presentations of Attention Deficit Hyperactivity Disorder (ADHD) within one year by investigator assessment using Diagnostic & Statistical Manual for Mental Disorders-Fifth Edition (DSM-5).
Both subjects and parents/guardians have provided their signed and dated informed consent form for the study.

Main exclusion criteria:

Subjects have received ADHD treatment for over 1 year or those who have received other ADHD treatment within 30 days prior to the study treatment initiation.
By investigator's evaluation, subjects are very anxious, tense or agitated.
Subjects known to be allergic to any ORADUR®-methylphenidate ingredients.
Subjects with an estimated intelligence quotient (IQ) < 80.
Subjects are taking a concomitant medication (ex: Monoamine Oxidase Inhibitor (MAOI)) that is likely to interfere with safe administration of methylphenidate within 14 day prior to the study treatment initiation.
Subjects are joining other clinical studies and receiving any other investigational medical products within 30 days prior to the study treatment initiation.
Subjects have glaucoma (narrow angle glaucoma), on-going seizure disorder, or other psychotic disorder.
Subjects have chronic tics, Tourette's syndrome, or a family history of Tourette's syndrome.
Subjects have clinically significant gastrointestinal problems, including narrowing of the gastrointestinal tract.
Subjects/caregivers are (in the case of subjects whose parents/caregivers were to fill out the study questionnaires) with drug or alcohol abuse/dependence within the prior 6 months.
By the investigators' discretion, subjects with serious or unstable medical illness that will interfere with the evaluations of study efficacy and safety.
In the investigators' opinion, subjects cannot understand or follow the instructions given in the study.
Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

Sites / Locations

Chang Gung Medical Foundation- Chiayi Branch
Tri-Service General Hospital
National Taiwan University Hospital
Chang Gung Medical Foundation- Linkuo Branch

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo First, then ORADUR®

ORADUR® First, then Placebo

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

SNAP-IV teacher form score in ORADUR®-Methylphenidate vs. placebo

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

SNAP-IV parent form score in ORADUR®-Methylphenidate (open titration period)

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

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

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

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

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.

Diagnostic & Statistical Manual for Mental Disorders-Fifth Edition (DSM-5) diagnosis in ORADUR®-Methylphenidate vs. placebo

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

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.

Clinical Global Impression-ADHD-Improvement (CGI-I) score in ORADUR®-Methylphenidate vs. placebo

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.

Full Information

NCT ID

NCT02450890

First Posted

May 19, 2015

Last Updated

November 30, 2021

Sponsor

Orient Pharma Co., Ltd.

Collaborators

Durect

1. Study Identification

Unique Protocol Identification Number

NCT02450890

Brief Title

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

Official Title

A Phase III, Multi-Center, Randomized, Double-blind, Placebo Controlled, Two-way Cross-over Clinical Study to Evaluate Safety and Efficacy of ORADUR®-Methylphenidate in Children and Adolescents With ADHD

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

June 2015 (undefined)

Primary Completion Date

February 2017 (Actual)

Study Completion Date

February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Orient Pharma Co., Ltd.

Collaborators

Durect

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Attention Deficit Hyperactivity Disorder

Keywords

ORADUR®-Methylphenidate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

114 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo First, then ORADUR®

Arm Type

Placebo Comparator

Arm Description

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)

Arm Title

ORADUR® First, then Placebo

Arm Type

Experimental

Arm Description

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)

Intervention Type

Drug

Intervention Name(s)

Placebo First, then ORADUR®

Other Intervention Name(s)

Placebo

Intervention Description

ORADUR®-Methylphenidate is available in three dosage forms (22mg, 33mg or 44mg). The optimal dose for each subject will be determined in the open-label titration period. After randomization, subjects will be subjected to the 4-week double-blind two-way cross-over treatment phase with 2 study periods (2 weeks of placebo and 2 weeks of ORADUR®-Methylphenidate oral capsule at the optimal dose, according to a pre-determined randomization schedule).

Intervention Type

Drug

Intervention Name(s)

ORADUR® First, then Placebo

Other Intervention Name(s)

Placebo

Intervention Description

Primary Outcome Measure Information:

Title

SNAP-IV teacher form score in ORADUR®-Methylphenidate vs. placebo

Description

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

SNAP-IV parent form score in ORADUR®-Methylphenidate (open titration period)

Description

Time Frame

2 weeks

Title

SNAP-IV parent form score in ORADUR®-Methylphenidate vs. placebo

Description

Time Frame

2 weeks

Title

Remission rate in ORADUR®-Methylphenidate vs. placebo

Description

To determine the remission rate of children and adolescents with ADHD who are administered ORADUR®-Methylphenidate versus those who are administered placebo.

Time Frame

2 weeks

Title

Conners' Teacher's Rating Scale score in ORADUR®-Methylphenidate vs. placebo

Description

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.

Time Frame

2 weeks

Title

Conners' Continuous Performance Test (CPT-II) performance in ORADUR®-Methylphenidate vs. placebo

Description

Time Frame

2 to 4 weeks

Title

Diagnostic & Statistical Manual for Mental Disorders-Fifth Edition (DSM-5) diagnosis in ORADUR®-Methylphenidate vs. placebo

Description

Time Frame

2 to 4 weeks

Title

Clinical Global Impression-ADHD-Severity (CGI-S) score in ORADUR®-Methylphenidate vs. placebo

Description

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.

Time Frame

2 weeks

Title

Clinical Global Impression-ADHD-Improvement (CGI-I) score in ORADUR®-Methylphenidate vs. placebo

Description

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Main inclusion criteria: Female or male subjects with age between 6 and 18 years old. Subjects with documented diagnosis of one of the three presentations of Attention Deficit Hyperactivity Disorder (ADHD) within one year by investigator assessment using Diagnostic & Statistical Manual for Mental Disorders-Fifth Edition (DSM-5). Both subjects and parents/guardians have provided their signed and dated informed consent form for the study. Main exclusion criteria: Subjects have received ADHD treatment for over 1 year or those who have received other ADHD treatment within 30 days prior to the study treatment initiation. By investigator's evaluation, subjects are very anxious, tense or agitated. Subjects known to be allergic to any ORADUR®-methylphenidate ingredients. Subjects with an estimated intelligence quotient (IQ) < 80. Subjects are taking a concomitant medication (ex: Monoamine Oxidase Inhibitor (MAOI)) that is likely to interfere with safe administration of methylphenidate within 14 day prior to the study treatment initiation. Subjects are joining other clinical studies and receiving any other investigational medical products within 30 days prior to the study treatment initiation. Subjects have glaucoma (narrow angle glaucoma), on-going seizure disorder, or other psychotic disorder. Subjects have chronic tics, Tourette's syndrome, or a family history of Tourette's syndrome. Subjects have clinically significant gastrointestinal problems, including narrowing of the gastrointestinal tract. Subjects/caregivers are (in the case of subjects whose parents/caregivers were to fill out the study questionnaires) with drug or alcohol abuse/dependence within the prior 6 months. By the investigators' discretion, subjects with serious or unstable medical illness that will interfere with the evaluations of study efficacy and safety. In the investigators' opinion, subjects cannot understand or follow the instructions given in the study. Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chi-Tai Chang, PhD

Organizational Affiliation

Orient Pharma Co., Ltd.

Official's Role

Study Director

Facility Information:

Facility Name

Chang Gung Medical Foundation- Chiayi Branch

City

Chiayi City

Country

Taiwan

Facility Name

Tri-Service General Hospital

City

Taipei City

ZIP/Postal Code

114

Country

Taiwan

Facility Name

National Taiwan University Hospital

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Facility Name

Chang Gung Medical Foundation- Linkuo Branch

City

Taoyuan

Country

Taiwan

12. IPD Sharing Statement

Citations:

PubMed Identifier

36251766

Citation

Shang CY, Chou TL, Hsieh CY, Gau SS. A Counting Stroop Functional Magnetic Resonance Imaging Study on the Effects of ORADUR-Methylphenidate in Drug-Naive Children with Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2022 Nov;32(9):467-475. doi: 10.1089/cap.2022.0024. Epub 2022 Oct 14.

Results Reference

derived

PubMed Identifier

33395356

Citation

Huang YS, Yeh CB, Chen CH, Shang CY, Gau SS. A Randomized, Double-Blind, Placebo-Controlled, Two-Way Crossover Clinical Trial of ORADUR-Methylphenidate for Treating Children and Adolescents with Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2021 Apr;31(3):164-178. doi: 10.1089/cap.2020.0104. Epub 2020 Dec 31.

Results Reference

derived

Learn more about this trial

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

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