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Attention Deficit Hyperactivity DisorderPhase 3NCT02704390

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

A Phase 3 study testing ORADUR®-Methylphenidate in people with Attention Deficit Hyperactivity Disorder, run by Orient Pharma Co., Ltd. at 3 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 long-term 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
What is being tested?
ORADUR®-Methylphenidate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
3 sitesTaiwan
Study dates
Jan 2016to Aug 2019
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. Subjects previously enrolled in OP-2PN012-301 study and completed 4-week study treatment
  2. Both subjects and parents/guardians have provided their signed and dated informed consent form for the study

Main Exclusion Criteria:

  1. Subjects who experienced unmanageable adverse events (AEs) after receiving ORADUR®-Methylphenidate
  2. 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
  3. Subjects are joining other clinical studies and receiving any other investigational medical products within 14 days prior to the study treatment initiation.
  4. By the investigators' discretion, subjects with serious or unstable medical illness that will interfere with the evaluations of study efficacy and safety
  5. By the investigators' discretion, subjects cannot understand or follow the instructions given in the study
  6. Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Trial locations and contacts

3 sites in 1 country.

Taiwan3 sites

  • Chang Gung Medical Foundation- Chiayi Branch

    Chiayi City

  • National Taiwan University Hospital

    Taipei, 100

  • Chang Gung Medical Foundation- Linkuo Branch

    Taoyuan

Other trials in Taiwan

About this study

Official title: An Extension Study to Evaluate the Long-term Safety and Efficacy of ORADUR®-Methylphenidate in Children and Adolescents With ADHD

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

Read the 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.

Being tested
ORADUR®-Methylphenidate
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.

  • ORADUR®-MethylphenidateDrug

    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.

Study groups in NCT02704390
Study groupRoleWhat they receive
ORADUR®-MethylphenidateExperimentalORADUR®-Methylphenidate oral capsule will be administered once daily in the morning for 24 months.
Receives: Drug: ORADUR®-Methylphenidate

What is being measured

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

  1. SNAP-IV teacher form scores in ORADUR®-Methylphenidate

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

    Measured: 24 months

Secondary outcomes (8)

  1. SNAP-IV parent form scores in ORADUR®-Methylphenidate

    Change from baseline of SNAP-IV parent form scores

    Measured: 24 months

  2. Remission rate in ORADUR®-Methylphenidate

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

    Measured: 24 months

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

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

    Measured: 24 months

  4. 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.

    Measured: 24 months

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

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

    Measured: 24 months

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

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

    Measured: 24 months

  7. 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)

    Measured: 24 months

  8. 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.

    Measured: 24 months

Timeline

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

  1. First posted10 Mar 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionAug 2019
  4. Study completionAug 2019

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02704390
Sponsor's protocol ID
OP-2PN012-301E
Status last verified
Nov 2021
First submitted
18 Jan 2016
Last updated
15 Dec 2021
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ORADUR®-Methylphenidate in people with Attention Deficit Hyperactivity Disorder, run by Orient Pharma Co., Ltd. at 3 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 15 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 3 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. 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 scores in ORADUR®-Methylphenidate (time frame: 24 months). 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 NCT02704390.

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 15 Dec 2021.

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