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

NCT ID: NCT02450890

Last Updated: 2021-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2017-02-28

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ORADUR®-Methylphenidate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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)

Group Type: PLACEBO_COMPARATOR

Placebo First, then ORADUR®

Intervention Type: 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).

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)

Group Type: EXPERIMENTAL

ORADUR® First, then Placebo

Intervention Type: 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).

Interventions

Placebo First, then ORADUR®

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

ORADUR® First, then Placebo

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

Other Intervention Names

Placebo; Placebo

Eligibility Criteria

Inclusion Criteria

1. Female or male subjects with age between 6 and 18 years old.

2. 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).

3. Both subjects and parents/guardians have provided their signed and dated informed consent form for the study.

Exclusion Criteria

1. 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.

2. By investigator's evaluation, subjects are very anxious, tense or agitated.

3. Subjects known to be allergic to any ORADUR®-methylphenidate ingredients.

4. Subjects with an estimated intelligence quotient (IQ) < 80.

5. 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.

6. Subjects are joining other clinical studies and receiving any other investigational medical products within 30 days prior to the study treatment initiation.

7. Subjects have glaucoma (narrow angle glaucoma), on-going seizure disorder, or other psychotic disorder.

8. Subjects have chronic tics, Tourette's syndrome, or a family history of Tourette's syndrome.

9. Subjects have clinically significant gastrointestinal problems, including narrowing of the gastrointestinal tract.

10. 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.

11. By the investigators' discretion, subjects with serious or unstable medical illness that will interfere with the evaluations of study efficacy and safety.

12. In the investigators' opinion, subjects cannot understand or follow the instructions given in the study.

13. Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Durect

INDUSTRY

Sponsor Role: collaborator

Orient Pharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chi-Tai Chang, PhD

Role: STUDY_DIRECTOR

Orient Pharma Co., Ltd.

Locations

Chang Gung Medical Foundation- Chiayi Branch

Chiayi City, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Tri-Service General Hospital

Taipei, , Taiwan

Chang Gung Medical Foundation- Linkuo Branch

Taoyuan District, , Taiwan

Countries

Taiwan

References

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.

Reference Type: DERIVED

PMID: 36251766 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33395356 (View on PubMed)

Other Identifiers

OP-2PN012-301

Identifier Type: -

Identifier Source: org_study_id