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

NCT05410626 | Unknown

• 2 other identifiers: COA.MU-DT/PY-IRB 2021/033.3003STY.COA004/2564
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

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

Conditions

Adhd

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The change from baseline in Clinical Global Impression-Severity (CGI-S) scale

  baseline, 4 and 8 week

• The difference in discontinuation rate between two groups of treatment

  4 and 8 week

• The difference in adverse events rate between two groups of treatment

  baseline, 4 and 8 week

Study Arms (2)

original

EXPERIMENTAL

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

generic

ACTIVE COMPARATOR

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

Interventions

prolong-release methylphenidate 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.

Also known as: Osmotic-controlled release oral delivery system(OROS) methylphenidate, Osmotic-controlled release methylphenidate

generic; original

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Chanatthida Muangkum

  Mahidol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chanatthida Muangkum

CONTACT

6654419935; chanatt.mua@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2022
• First Posted: June 8, 2022
• Study Start: June 1, 2022
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: June 8, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share