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

NCT02450890 | Completed Phase 3 DMC

• 1 other identifier: OP-2PN012-301
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to evaluate the 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 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

  2 weeks

Secondary Outcomes (8)

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

  2 weeks

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

  2 weeks

• Remission rate in ORADUR®-Methylphenidate vs. placebo

  2 weeks

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

  2 weeks

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

  2 to 4 weeks

Study Arms (2)

Placebo First, then ORADUR®

PLACEBO COMPARATOR

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)

Drug: Placebo First, then ORADUR®

ORADUR® First, then Placebo

EXPERIMENTAL

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)

Drug: ORADUR® First, then Placebo

Interventions

Placebo First, then ORADUR® DRUG

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).

Also known as: Placebo

Placebo First, then ORADUR®

ORADUR® First, then Placebo DRUG

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).

Also known as: Placebo

ORADUR® First, then Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (4)

Chang Gung Medical Foundation- Chiayi Branch

Chiayi City, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Tri-Service General Hospital

Taipei, 114, Taiwan

Location

Chang Gung Medical Foundation- Linkuo Branch

Taoyuan District, Taiwan

Location

Related Publications (2)

• 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.

  PMID: 36251766 DERIVED

• 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.

  PMID: 33395356 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

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

Study Officials

• Chi-Tai Chang, PhD

  Orient Pharma Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2015
• First Posted: May 21, 2015
• Study Start: June 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: December 6, 2021

Record last verified: 2021-11

Locations

TW (4)