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

NCT05410626 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2022-06-08

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Mahidol University

    lead OTHER

Principal Investigators

  • Chanatthida Muangkum · Mahidol University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2022-08-31
Completion
2022-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05410626 on ClinicalTrials.gov