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Evaluate Long-term 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

ORADUR®-Methylphenidate

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:

Subjects previously enrolled in OP-2PN012-301 study and completed 4-week study treatment
Both subjects and parents/guardians have provided their signed and dated informed consent form for the study

Main Exclusion Criteria:

Subjects who experienced unmanageable adverse events (AEs) after receiving ORADUR®-Methylphenidate
Subjects are taking a concomitant medication (ex: Monoamine Oxidase Inhibitor (MAOI) or other ADHD treatments) 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 14 days prior to the study treatment initiation.
By the investigators' discretion, subjects with serious or unstable medical illness that will interfere with the evaluations of study efficacy and safety
By the investigators' discretion, 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
National Taiwan University Hospital
Chang Gung Medical Foundation- Linkuo Branch

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ORADUR®-Methylphenidate

Arm Description

ORADUR®-Methylphenidate oral capsule will be administered once daily in the morning for 24 months.

Outcomes

Primary Outcome Measures

SNAP-IV teacher form scores in ORADUR®-Methylphenidate

Change from baseline of Swanson, Nolan, and Pelham-IV (SNAP-IV) teacher form scores

Secondary Outcome Measures

SNAP-IV parent form scores in ORADUR®-Methylphenidate

Change from baseline of SNAP-IV parent form scores

Remission rate in ORADUR®-Methylphenidate

Remission rate as assessed by SNAP-IV teacher form and SNAP-IV parent form

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

Change from baseline of Conners' Continuous Performance Test (CPT-II) performance results

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

Change from baseline (screening period) of Diagnostic & Statistical Manual for Mental Disorders-Fifth Edition (DSM-5) diagnosis. During study period, DSM-5 diagnosis will be performed at each visit. Investigator will check the diagnostic classification, the dianostic criteria sets and the descriptive test of DSM-5 questionnaire and confirm the severity of ADHD based on subject's current condition.

Clinical Global Impression-ADHD-Severity (CGI-S) scores in ORADUR®-Methylphenidate

Change from baseline of Clinical Global Impression-ADHD-Severity (CGI-S) scores

Clinical Global Impression-ADHD-Improvement (CGI-I) scores in ORADUR®-Methylphenidate

Change from baseline of Clinical Global Impression-ADHD-Improvement (CGI-I) scores

Computerized Cambridge Neuropsychological Test Automated Battery (CANTAB) performance in ORADUR®-Methylphenidate

Change from baseline of Computerized Cambridge Neuropsychological Test Automated Battery (CANTAB) performance result (at National Taiwan University Hospital, NTUH, only)

Treatment compliance in ORADUR®-Methylphenidate

Evaluate the treatment compliance during study period. Compliance will be assessed by the result of drug accountability and presented by the missing dose rate.

Full Information

NCT ID

NCT02704390

First Posted

January 18, 2016

Last Updated

November 30, 2021

Sponsor

Orient Pharma Co., Ltd.

Collaborators

Durect

1. Study Identification

Unique Protocol Identification Number

NCT02704390

Brief Title

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

Official Title

An Extension Study to Evaluate the Long-term 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

January 2016 (undefined)

Primary Completion Date

August 2019 (Actual)

Study Completion Date

August 2019 (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 long-term safety and efficacy of ORADUR®-Methylphenidate in children and adolescents with ADHD.

Detailed Description

In order to evaluate the long-term safety and efficacy of ORADUR®-Methylphenidate in children and adolescents with ADHD, subjects who participated in the previous OP-2PN012-301 study will be invited to join this extension study for 24-month follow-up. Subjects will continue to receive ORADUR®-Methylphenidate at the previously determined optimal dose.

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

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ORADUR®-Methylphenidate

Arm Type

Experimental

Arm Description

ORADUR®-Methylphenidate oral capsule will be administered once daily in the morning for 24 months.

Intervention Type

Drug

Intervention Name(s)

ORADUR®-Methylphenidate

Intervention Description

ORADUR®-Methylphenidate is available in three dosage forms, 22 mg, 33 mg or 44 mg. Subjects will continue to receive ORADUR®-Methylphenidate at the previously determined optimal dose for 24 months.

Primary Outcome Measure Information:

Title

SNAP-IV teacher form scores in ORADUR®-Methylphenidate

Description

Change from baseline of Swanson, Nolan, and Pelham-IV (SNAP-IV) teacher form scores

Time Frame

24 months

Secondary Outcome Measure Information:

Title

SNAP-IV parent form scores in ORADUR®-Methylphenidate

Description

Change from baseline of SNAP-IV parent form scores

Time Frame

24 months

Title

Remission rate in ORADUR®-Methylphenidate

Description

Remission rate as assessed by SNAP-IV teacher form and SNAP-IV parent form

Time Frame

24 months

Title

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

Description

Change from baseline of Conners' Continuous Performance Test (CPT-II) performance results

Time Frame

24 months

Title

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

Description

Time Frame

24 months

Title

Clinical Global Impression-ADHD-Severity (CGI-S) scores in ORADUR®-Methylphenidate

Description

Change from baseline of Clinical Global Impression-ADHD-Severity (CGI-S) scores

Time Frame

24 months

Title

Clinical Global Impression-ADHD-Improvement (CGI-I) scores in ORADUR®-Methylphenidate

Description

Change from baseline of Clinical Global Impression-ADHD-Improvement (CGI-I) scores

Time Frame

24 months

Title

Computerized Cambridge Neuropsychological Test Automated Battery (CANTAB) performance in ORADUR®-Methylphenidate

Description

Change from baseline of Computerized Cambridge Neuropsychological Test Automated Battery (CANTAB) performance result (at National Taiwan University Hospital, NTUH, only)

Time Frame

24 months

Title

Treatment compliance in ORADUR®-Methylphenidate

Description

Evaluate the treatment compliance during study period. Compliance will be assessed by the result of drug accountability and presented by the missing dose rate.

Time Frame

24 months

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: Subjects previously enrolled in OP-2PN012-301 study and completed 4-week study treatment Both subjects and parents/guardians have provided their signed and dated informed consent form for the study Main Exclusion Criteria: Subjects who experienced unmanageable adverse events (AEs) after receiving ORADUR®-Methylphenidate Subjects are taking a concomitant medication (ex: Monoamine Oxidase Inhibitor (MAOI) or other ADHD treatments) 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 14 days prior to the study treatment initiation. By the investigators' discretion, subjects with serious or unstable medical illness that will interfere with the evaluations of study efficacy and safety By the investigators' discretion, 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

Shirley Lin

Organizational Affiliation

Orient pharma

Official's Role

Study Director

Facility Information:

Facility Name

Chang Gung Medical Foundation- Chiayi Branch

City

Chiayi City

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

Learn more about this trial

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

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