NCT05410626

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-06-01
• Primary completion: 2022-08-31
• Completion: 2022-08-31
• First posted: 2022-06-08
• Last updated: 2022-06-08