Clinical Trials List
Protocol NumberOP-2PN012-301
NCT Number(ClinicalTrials.gov Identfier)NCT02450890
2015-06-01 - 2017-02-28
Phase III
Terminated4
ICD-10F90.1
Attention-deficit hyperactivity disorder, predominantly hyperactive type
ICD-10F90.2
Attention-deficit hyperactivity disorder, combined type
ICD-10F90.8
Attention-deficit hyperactivity disorder, other type
ICD-10F90.9
Attention-deficit hyperactivity disorder, unspecified type
ICD-9314.01
Attention deficit disorder, with hyperactivity
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
-
Trial Applicant
Orient PHARMA Co., Ltd.
-
Sponsor
Orient Pharma Co., Ltd.
-
Trial scale
Taiwan Multiple Center
-
Update
2025/08/19
Investigators and Locations
Co-Principal Investigator
- 潘姵吟 Division of Psychiatry
The Actual Total Number of Participants Enrolled
0 Completed
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 蔡景淑 Division of Psychiatry
The Actual Total Number of Participants Enrolled
0 Completed
The Actual Total Number of Participants Enrolled
0 Completed
Condition/Disease
ADHD (Attention Deficit Hyperactivity Disorder)
Objectives
Primary Objective
The primary objective of the study is defined as:
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.
Secondary Objectives
The secondary objectives of the study are:
1) 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.
2) To determine the remission rate of children and adolescents with ADHD who are
administered ORADUR®-Methylphenidate versus those who are administered placebo.
3) 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.
4) 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.
5) To determine the Diagnostic & Statistical Manual for Mental Disorders-Fifth Edition
(DSM-V) score of children and adolescents with ADHD who are administered
ORADUR®-Methylphenidate versus those who are administered placebo.
6) 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.
7) 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.
8) To determine brain structural and functional connectivity by the magnetic resonance
imaging (MRI) image of the brain function of children and adolescents with ADHD
who are administered ORADUR®-Methylphenidate versus those who are administered
placebo (at National Taiwan University Hospital, NTUH, only).
9) To determine the Computerized Cambridge Neuropsychological Test Automated
Battery (CANTAB) performance of children and adolescents with ADHD who are
administered ORADUR®-Methylphenidate versus those who are administered placebo
(at National Taiwan University Hospital, NTUH, only).
Test Drug
ORADUR-Methylphenidate
Active Ingredient
Methylphenidate Hydrochloride
Dosage Form
Oral Capsule
Dosage
22
33
44
33
44
Endpoints
1. Primary Endpoint:
To compare the change from baseline of SNAP-IV teacher form score between
children and adolescents with ADHD who are administered ORADUR®-
Methylphenidate versus those who are administered placebo at Week 2 and Week 4.
2. Secondary Endpoints:
1) To compare the change from baseline of SNAP-IV parent form score between
children and adolescents with ADHD who are administered ORADUR®-Methylphenidate versus those who are administered placebo at Week 2 and Week4.
2) To compare the remission* rate of children and adolescents with ADHD who are
administered ORADUR®-Methylphenidate versus those who are administered
placebo at Week 2 by SNAP-IV teacher form and SNAP-IV parent form.
*Remission is defined as score ≤ 1 on each item of the first 18 items of SNAP-IV
form.
3) To compare the change from baseline of Conners’ teacher’s rating scale score
between children and adolescents with ADHD who are administered ORADUR®-
Methylphenidate versus those who are administered placebo at Week 2 and Week
4.
4) To compare the change from baseline of Conners’ CPT-II performance between
children and adolescents with ADHD who are administered ORADUR®-
Methylphenidate versus those who are administered placebo at Week 2 and Week
4.
5) To compare the change from baseline of DSM-V score between children and
adolescents with ADHD who are administered ORADUR®-Methylphenidate
versus those who are administered placebo at Week 2 and Week 4 by interview.
6) To compare the change from baseline of CGI-S between children and adolescents
with ADHD who are administered ORADUR®-Methylphenidate versus those who
are administered placebo at Week 2 and Week 4.
7) To compare the CGI-I between children and adolescents with ADHD who are
administered ORADUR®-Methylphenidate versus those who are administered
placebo at Week 2 and Week 4.
8) To compare the change from baseline of brain structural and functional
connectivity by the MRI image between children and adolescents with ADHD who
are administered ORADUR®-Methylphenidate versus those who are administered
placebo at Week 2 (at NTUH only).
9) To compare the change from baseline of CANTAB performance between children
and adolescents with ADHD who are administered ORADUR®-Methylphenidate
versus those who are administered placebo at Week 2 and Week 4 (at NTUH
only).
3. Safety Endpoints
1) Adverse events (AEs)
2) Serious adverse events (SAEs)
3) Vital signs (Blood pressure and heart rate only)
4) Body weight
5) Physical examination findings
6) Electrocardiogram (ECG)
7) Laboratory Changes
To compare the change from baseline of SNAP-IV teacher form score between
children and adolescents with ADHD who are administered ORADUR®-
Methylphenidate versus those who are administered placebo at Week 2 and Week 4.
2. Secondary Endpoints:
1) To compare the change from baseline of SNAP-IV parent form score between
children and adolescents with ADHD who are administered ORADUR®-Methylphenidate versus those who are administered placebo at Week 2 and Week4.
2) To compare the remission* rate of children and adolescents with ADHD who are
administered ORADUR®-Methylphenidate versus those who are administered
placebo at Week 2 by SNAP-IV teacher form and SNAP-IV parent form.
*Remission is defined as score ≤ 1 on each item of the first 18 items of SNAP-IV
form.
3) To compare the change from baseline of Conners’ teacher’s rating scale score
between children and adolescents with ADHD who are administered ORADUR®-
Methylphenidate versus those who are administered placebo at Week 2 and Week
4.
4) To compare the change from baseline of Conners’ CPT-II performance between
children and adolescents with ADHD who are administered ORADUR®-
Methylphenidate versus those who are administered placebo at Week 2 and Week
4.
5) To compare the change from baseline of DSM-V score between children and
adolescents with ADHD who are administered ORADUR®-Methylphenidate
versus those who are administered placebo at Week 2 and Week 4 by interview.
6) To compare the change from baseline of CGI-S between children and adolescents
with ADHD who are administered ORADUR®-Methylphenidate versus those who
are administered placebo at Week 2 and Week 4.
7) To compare the CGI-I between children and adolescents with ADHD who are
administered ORADUR®-Methylphenidate versus those who are administered
placebo at Week 2 and Week 4.
8) To compare the change from baseline of brain structural and functional
connectivity by the MRI image between children and adolescents with ADHD who
are administered ORADUR®-Methylphenidate versus those who are administered
placebo at Week 2 (at NTUH only).
9) To compare the change from baseline of CANTAB performance between children
and adolescents with ADHD who are administered ORADUR®-Methylphenidate
versus those who are administered placebo at Week 2 and Week 4 (at NTUH
only).
3. Safety Endpoints
1) Adverse events (AEs)
2) Serious adverse events (SAEs)
3) Vital signs (Blood pressure and heart rate only)
4) Body weight
5) Physical examination findings
6) Electrocardiogram (ECG)
7) Laboratory Changes
Inclution 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-V).
3) Blood pressure within the 95th percentile for age, gender, and height.
4) Subjects can swallow study specific capsule (18 mm) without difficulty.
5) Both subjects and parents/guardians have provided their signed and dated
informed consent form for the study.
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-V).
3) Blood pressure within the 95th percentile for age, gender, and height.
4) Subjects can swallow study specific capsule (18 mm) without difficulty.
5) 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 full-scale 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.
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 full-scale 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.
The Estimated Number of Participants
-
Taiwan
110 participants
-
Global
110 participants
