Clinical trialNCT01239030CompletedPhase 3Interventional

Efficacy and Safety of Methylphenidate HCl ER Capsules in Children and Adolescents With ADHD

SponsorRhodes Pharmaceuticals, L.P.Enrollment230ADHDAttention Deficit Hyperactivity Disorder

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This multi-center parallel study is designed to study the efficacy and safety of fixed doses of methylphenidate extended release (ER) capsules of four dose levels compared with a placebo group in pediatric patients with Attention Deficit Hyperactivity Disorder (ADHD) who are between 6 and 18 years old.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Laurence Greenhill, M.D.
New York State Psychiatric Institute / Columbia University
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗
Robert J. Kupper, Ph.D.
Rhodes Phamaceuticals, L.P.
Study Chair
clinicaltrials.gov ↗
Sharon B. Wigal, Ph.D.
University of California, Irvine / Child Development Center
Principal Investigator
clinicaltrials.gov ↗
Wei-wei Chang, Ph.D.
NuTec Incorporated
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

16 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Clinical Study Centers, Llc
Little Rock, Arkansas, United States
University of California, Irvine/child Development Center
Irvine, California, United States
Synergy Research
National City, California, United States
Florida Clinical Research Center, Llc
Bradenton, Florida, United States
Behavioral Clinical Research, Inc.
Lauderhill, Florida, United States
Martin Kane, Do
Maitland, Florida, United States
Segal Institute for Clinical Research, North Miami Outpatient Clinic
North Miami, Florida, United States
South Shore Psychiatric Services, Pc
Marshfield, Massachusetts, United States
Precise Research Center
Madison, Mississippi, United States
Center for Psychiatry and Behavioural Medicine Inc
Las Vegas, Nevada, United States
New York State Psychiatric Institute/columbia University
New York, New York, United States
Department of Psychiatry, Duke University Medical Center
Durham, North Carolina, United States
Ctmg
New Bern, North Carolina, United States
University of Cincinnati College of Medicine/ppsi
Cincinnati, Ohio, United States
University Hospital Case Medical Center
Cleveland, Ohio, United States
Wharton Research Center, Inc.
Wharton, Texas, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Methylphenidate Hydrochloride Extended Release CapsulesPlacebo

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 30 Nov 2010
Primary completion: 29 Feb 2012
Completion: 31 Mar 2012
Last update posted: 22 Feb 2023
Registered enrollment: 230
Registry id: NCT01239030

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.