The Study of Efficacy and Safety of Generic Methylphenidate Prolong-released Comparison With Original

Study Overview
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Brief Summary
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This study is a cross-over trial, design to determine the efficacy and safety of generic and original prolong-release methylphenidate (PR-MPH) in children with ADHD who had received immediate-release methylphenidate treatment

Detailed Description
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This 4 weeks cross-over study will recruit 78 children, aged 6 to 12 years, with ADHD. They will be randomized to receive generic or original PR-MPH for 4 weeks and then switch to another brand for 4 weeks. Swanson, Nolan and Pelham parent rating scale is used to measure the primary outcome.

Official Title
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Efficacy and Safety of Generic Methylphenidate Prolong-released Comparison With Original in Child With Attention-deficit-hyperactive Disorders

Conditions
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Adhd

Intervention / Treatment
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* Drug: prolong-release methylphenidate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 6 to 12 years Diagnosis of ADHD according to DSM-5 of ICD-10 Patient who receiving a stable dose of IR-MPH for at least 4 weeks before screening Patient who has a stable clinical symptoms. Patients or their legal representatives provide informed consent prior to enrollment Exclusion Criteria: Patients who present of a serious obstructive gastrointestinal disease Patients cannot swallow the whole tablet Patients with depression, schizophrenia, bipolar disorder, and 1-month substance use prior to study Patients who present of an unstable co-morbidity: anxiety, seizure, conduct disorder and oppositional defiant disorder Patients or patients' family have a history of poor compliance Patients who receiving monoamine oxidase inhibitors antidepressant or stop taking not more than 14 days Patients who receiving PR-MPH except stop taking more than 7 days Patients' parent has a family problem and currently treatment with family therapy or adjust medication

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: original<br>This study use 18 and 36 mg of original prolong-release methylphenidate. Dosing of Medication is equivalent to immediate-release. Medication administration is once daily in the morning. | Drug: prolong-release methylphenidate<br>* This randomization, cross-over design study will enroll subjects who receive a stable dose of immediate-release methylphenidate (IR-MPH) for at least 4 weeks. Eligible subjects will be switching from IR-MPH to the first brand prolong-release methylphenidate (PR-MPH) for 4 weeks and switching to another brand for 4 weeks. The study consists of 3 parts: screening, study period, and post-treatment follow-up. The duration of this study will be 8 weeks with 2 visits during the study period. The primary outcome is the efficacy of treatment will be evaluated by SNAP-IV.<br>* Other names: Osmotic-controlled release oral delivery system(OROS) methylphenidate, Osmotic-controlled release methylphenidate;|
| Active Comparator: generic<br>This study use 18 and 36 mg of generic prolong-release methylphenidate. Dosing of Medication is equivalent to immediate-release. Medication administration is once daily in the morning. | Drug: prolong-release methylphenidate<br>* This randomization, cross-over design study will enroll subjects who receive a stable dose of immediate-release methylphenidate (IR-MPH) for at least 4 weeks. Eligible subjects will be switching from IR-MPH to the first brand prolong-release methylphenidate (PR-MPH) for 4 weeks and switching to another brand for 4 weeks. The study consists of 3 parts: screening, study period, and post-treatment follow-up. The duration of this study will be 8 weeks with 2 visits during the study period. The primary outcome is the efficacy of treatment will be evaluated by SNAP-IV.<br>* Other names: Osmotic-controlled release oral delivery system(OROS) methylphenidate, Osmotic-controlled release methylphenidate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from baseline in parent Swansan, Nolan and Pelham version IV (SNAP-IV) parent rating score | SNAP-IV,26 items score, included 18-items that reflect ADHD symptoms and 8-items that reflect oppositional defiant disorder symptoms | baseline, 4 and 8 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from baseline in Clinical Global Impression-Severity (CGI-S) scale | CGI-S scale is measured the severity of symptoms by physician, rated from 1 (normal) to 7 (among the most severely ill patients) | baseline, 4 and 8 week | 
| The difference in discontinuation rate between two groups of treatment | Discontinuation rate is a proportion of patients who discontinue medication from any reason | 4 and 8 week | 
| The difference in adverse events rate between two groups of treatment | adverse events rate is a proportion of patients who have the adverse events | baseline, 4 and 8 week |