Sponsor study identifier
interventional
64
1 country
3
Study Start
January 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2019
Actual (reported)Study Completion
August 2019
Actual (reported)The purpose of this study is to evaluate the long-term safety and efficacy of ORADUR®-Methylphenidate in children and adolescents with ADHD.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2016
Date type not reportedThis date has not been verified as actual or estimated.
January 18, 2016
Actual (reported)March 10, 2016
Actual (reported)August 2019
Actual (reported)August 2019
Actual (reported)SNAP-IV teacher form scores in ORADUR®-Methylphenidate
Change from baseline of Swanson, Nolan, and Pelham-IV (SNAP-IV) teacher form scores
24 months
SNAP-IV parent form scores in ORADUR®-Methylphenidate
24 months
Remission rate in ORADUR®-Methylphenidate
24 months
Conners' Continuous Performance Test (CPT-II) performance in ORADUR®-Methylphenidate
24 months
Diagnostic & Statistical Manual for Mental Disorders-Fifth Edition (DSM-5) diagnosis in ORADUR®-Methylphenidate
24 months
Clinical Global Impression-ADHD-Severity (CGI-S) scores in ORADUR®-Methylphenidate
24 months
ORADUR®-Methylphenidate oral capsule will be administered once daily in the morning for 24 months.
ORADUR®-Methylphenidate is available in three dosage forms, 22 mg, 33 mg or 44 mg. Subjects will continue to receive ORADUR®-Methylphenidate at the previously determined optimal dose for 24 months.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Chang Gung Medical Foundation- Chiayi Branch
Chiayi City, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Chang Gung Medical Foundation- Linkuo Branch
Taoyuan, Taiwan
Shirley Lin
Orient pharma
64 participants (actual enrollment reported by the registry).
First Submitted
January 18, 2016
First Posted
March 10, 2016
Study Start
January 2016
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
August 2019
Actual (reported)Study Completion
August 2019
Actual (reported)Last Updated
December 15, 2021
Record last verified: 2021-11
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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