E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Attention Deficit Hyperactivity Disorder |
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E.1.1.1 | Medical condition in easily understood language |
being hyperactive and/or inattentive |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003735 |
E.1.2 | Term | Attention deficit-hyperactivity disorder |
E.1.2 | System Organ Class | 100000004873 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The purpose of this study is to evaluate the optimal dosages of Osmotic Release Oral System (OROS) methylphenidate in participants with Attention Deficit Hyperactivity Disorder (ADHD). |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the overall efficiacy and safety of Osmotic Release Oral System (OROS) methylphenidate on the improvement of Attention Deficit Hyperactivity Disorder symptoms |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Guardian has provided a written consent for subject
- Male and female patients from 6 to 18 years of age
- Subject diagnosed with ADHD by K-SADS-PL(Kiddie-Schedule for Affective Disorders and Schizophrenia-Present and Lifetime Version- Korean Version), and it is determined that he/she requires drug therapy
- Able to observe the study’s visit schedule, and the subject and his/her parent/guardians are willing and able to complete the evaluation defined in the Clinical Protocol during the treatment period
- Subject/guardian who can understand the participation in the study and spontaneously request discontinuation of the study anytime |
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E.4 | Principal exclusion criteria |
- Subject who was administered with Methylphenidate HCl besides Concerta® within 24 hrs of study participation
- Subject who was administered with Concerta within the recent three months
- Subject who is known to have hypersensitivity to Methylphenidate HCI or other ingredient of this product
- Subject who was administered with the following medications within the last 4 weeks: clonidine or alpha-2 adrenergic receptor agonist, anti-depressants like TCAs or SSRIs (except for Fluoxetine, a subject administered with the drug within 12 weeks is included in the exclusion criteria.), theophylline, coumarin or anticonvulsants, anti-psychotics, benzodiazepines, modafinil
- Subject with clinically significant GI problem with a possibility of GI tract obstruction including GI tract stenosis (by pathological or doctor’s diagnosis). For example, intestinal inflammation, short gut syndrome due to adhesion or decrease of transit time, previous history of peritonitis, cystic fibrosis, chronic intestinal pseudo-obstruction or Meckel’s diverticulum
- Subject with glaucoma, current seizure disorders like epilepsy, mental disease, Tourette’s syndrome, cardiovascular disease including moderate to severe hypertension, excessive agitation or restlessness, or hyperthyroidism
- Subject with other accompanying disease that could inhibit the safe administration of methylphenidate, or subject who is administered with such concomitant drugs
- Subject unable to swallow the investigational product
- When drug abuse is currently known or suspected, or subject has a history of drug abuse
- Subject with mental retardation (IQ of less than 70)
- Subject with high risk of pregnancy
- Subject either started or changed to a new behavioral therapy for ADHD during the study period
- Subject with overall developmental disorder
- Subject who is taking oriental herbal medicines |
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E.5 End points |
E.5.1 | Primary end point(s) |
- Dupaul ADHD Rating Scale (K-ARS) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
- Baseline and/or Week 12
|
|
E.5.2 | Secondary end point(s) |
- ADS
- IOWA CPRS
- CDI (Children’s Depression Inventory)
- STAIC (State-Trait Anxiety Inventory for Children)
- YGTSS (Severity)
- LPS-C
- APRS (Academic Performance Rating Scale)
- CGI (Clinical Global Impression) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- Baseline and/or Week 12 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial months | 11 |