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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Adhd
• Intervention / Treatment: Drug: prolong-release methylphenidate

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 78
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chanatthida Muangkum; Phone Number: 6654419935; Email: chanatt.mua@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: original; 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; 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.; Other Names: Osmotic-controlled release oral delivery system(OROS) methylphenidate, Osmotic-controlled release methylphenidate
Active Comparator: generic; 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; 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.; Other Names: Osmotic-controlled release oral delivery system(OROS) methylphenidate, Osmotic-controlled release methylphenidate

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Chanatthida Muangkum, Mahidol University

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): August 31, 2022
• Study Completion (Anticipated): August 31, 2022

Study Registration Dates

• First Submitted: June 5, 2022
• First Submitted That Met QC Criteria: June 5, 2022
• First Posted (Actual): June 8, 2022

Study Record Updates

• Last Update Posted (Actual): June 8, 2022
• Last Update Submitted That Met QC Criteria: June 5, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Methylphenidate
• Other Study ID Numbers: COA.MU-DT/PY-IRB 2021/033.3003; STY.COA004/2564 (Other Identifier: Srithanya hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No