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

Sponsor
Mahidol University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05410626
Collaborator
(none)
78
Enrollment
2
Arms
3
Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: prolong-release methylphenidate
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
78 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Generic Methylphenidate Prolong-released Comparison With Original in Child With Attention-deficit-hyperactive Disorders
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Aug 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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.
Other Names:
  • Osmotic-controlled release oral delivery system(OROS) methylphenidate, Osmotic-controlled release methylphenidate

    		•
    Active Comparator: 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.

    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.
    Other Names:
  • Osmotic-controlled release oral delivery system(OROS) methylphenidate, Osmotic-controlled release methylphenidate

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The change from baseline in parent Swansan, Nolan and Pelham version IV (SNAP-IV) parent rating score [baseline, 4 and 8 week]

      SNAP-IV,26 items score, included 18-items that reflect ADHD symptoms and 8-items that reflect oppositional defiant disorder symptoms

    Secondary Outcome Measures

    1. The change from baseline in Clinical Global Impression-Severity (CGI-S) scale [baseline, 4 and 8 week]

      CGI-S scale is measured the severity of symptoms by physician, rated from 1 (normal) to 7 (among the most severely ill patients)

    2. The difference in discontinuation rate between two groups of treatment [4 and 8 week]

      Discontinuation rate is a proportion of patients who discontinue medication from any reason

    3. The difference in adverse events rate between two groups of treatment [baseline, 4 and 8 week]

      adverse events rate is a proportion of patients who have the adverse events

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Mahidol University

    Investigators

    • Principal Investigator: Chanatthida Muangkum, Mahidol University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mahidol University
    ClinicalTrials.gov Identifier:
    NCT05410626
    Other Study ID Numbers:
    • COA.MU-DT/PY-IRB 2021/033.3003
    • STY.COA004/2564
    First Posted:
    Jun 8, 2022
    Last Update Posted:
    Jun 8, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Methylphenidate

    Study Results

    No Results Posted as of Jun 8, 2022