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

NCT ID: NCT05410626

Last Updated: 2022-06-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2022-08-31

Brief Summary

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

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.

Conditions

Adhd

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

prolong-release methylphenidate

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

prolong-release methylphenidate

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Osmotic-controlled release oral delivery system(OROS) methylphenidate, Osmotic-controlled release methylphenidate

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chanatthida Muangkum

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Central Contacts

Chanatthida Muangkum

Role: CONTACT

chanatt.mua@gmail.com

6654419935

Other Identifiers

STY.COA004/2564

Identifier Type: OTHER

Identifier Source: secondary_id

COA.MU-DT/PY-IRB 2021/033.3003

Identifier Type: -

Identifier Source: org_study_id