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

Adhd Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05410626
• Other study ID #: COA.MU-DT/PY-IRB 2021/033.3003
• Secondary ID: STY.COA004/2564
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: August 31, 2022

Study information

• Verified date: June 2022
• Source: Mahidol University
• Contact: Chanatthida Muangkum
• Phone: 6654419935
• Email: chanatt.mua[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 78
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Adhd

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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