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

NCT02704390 | Completed Phase 3 DMC

• 1 other identifier: OP-2PN012-301E
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 3

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ORADUR®-Methylphenidate

Outcome Measures

Primary Outcomes (1)

• SNAP-IV teacher form scores in ORADUR®-Methylphenidate

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

  24 months

Secondary Outcomes (8)

• SNAP-IV parent form scores in ORADUR®-Methylphenidate

  24 months

• Remission rate in ORADUR®-Methylphenidate

  24 months

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

  24 months

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

  24 months

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

  24 months

Study Arms (1)

ORADUR®-Methylphenidate

EXPERIMENTAL

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

Drug: ORADUR®-Methylphenidate

Interventions

ORADUR®-Methylphenidate DRUG

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.

ORADUR®-Methylphenidate

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Orient Pharma Co., Ltd.: lead
• Durect: collaborator

Study Sites (3)

Chang Gung Medical Foundation- Chiayi Branch

Chiayi City, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Chang Gung Medical Foundation- Linkuo Branch

Taoyuan District, Taiwan

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Shirley Lin

  Orient pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2016
• First Posted: March 10, 2016
• Study Start: January 1, 2016
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: December 15, 2021

Record last verified: 2021-11

Locations

TW (3)