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Attention Deficit Hyperactivity DisorderPhase 3NCT02450890

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

A Phase 3 study of Attention Deficit Hyperactivity Disorder, run by Orient Pharma Co., Ltd. at 4 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety and efficacy of ORADUR®-Methylphenidate in children and adolescents with ADHD. Read more about this study

Who is it for?
Ages 6 to 18 years
Conditions the study is for
Attention Deficit Hyperactivity Disorder
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
114 participants
Where
4 sitesTaiwan
Study dates
Jun 2015to Feb 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Main 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.

Main 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.

Trial locations and contacts

4 sites in 1 country.

Taiwan4 sites

  • Chang Gung Medical Foundation- Chiayi Branch

    Chiayi City

  • National Taiwan University Hospital

    Taipei, 100

  • Tri-Service General Hospital

    Taipei, 114

  • Chang Gung Medical Foundation- Linkuo Branch

    Taoyuan

Other trials in Taiwan

About this study

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

The purpose of this study is to evaluate the safety and efficacy of ORADUR®-Methylphenidate in children and adolescents with ADHD.

Read the 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.

Being tested
Placebo First, then ORADUR®, ORADUR® First, then Placebo
Keywords
ORADUR®-Methylphenidate
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Placebo First, then ORADUR®Drug

    Also called 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).

  • ORADUR® First, then PlaceboDrug

    Also called 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).

Study groups in NCT02450890
Study groupRoleWhat they receive
Placebo First, then ORADUR®Placebo comparatorPlacebo 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)
Receives: Drug: Placebo First, then ORADUR®
ORADUR® First, then PlaceboExperimentalORADUR®-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)
Receives: Drug: ORADUR® First, then Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 2 weeks

Secondary outcomes (8)

  1. 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.

    Measured: 2 weeks

  2. 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.

    Measured: 2 weeks

  3. 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.

    Measured: 2 weeks

  4. 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.

    Measured: 2 weeks

  5. 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.

    Measured: 2 to 4 weeks

  6. 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.

    Measured: 2 to 4 weeks

  7. 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.

    Measured: 2 weeks

  8. 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.

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionFeb 2017
  4. Study completionFeb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02450890
Sponsor's protocol ID
OP-2PN012-301
Status last verified
Nov 2021
First submitted
19 May 2015
Last updated
6 Dec 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 36251766

  • 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.

    PubMed 33395356

Questions about this trial

What is this clinical trial studying?

A Phase 3 study of Attention Deficit Hyperactivity Disorder, run by Orient Pharma Co., Ltd. at 4 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SNAP-IV teacher form score in ORADUR®-Methylphenidate vs. placebo (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02450890, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2021.

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