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Study identifier: NCT01239030 Synced from ClinicalTrials.gov · August 08, 2026
● Study status: Completed

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

Condition: Attention Deficit Hyperactivity Disorder · ADHD  ·  Sponsor: Rhodes Pharmaceuticals, L.P.

PhasePhase 3
Planned participants230
Who can joinAll sexes, 6 Years to 18 Years
Healthy volunteersNoCheck eligibility criteria ↓
Where16 locations

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

Inclusion Criteria: * Males and females ages 6 up to 18 * ADHD diagnosis with ADHD Rating Scale - 4th Edition scores ≥ 90th percentile * In need of treatment for ADHD and able to have 2-day washout from previous medication * Females of child-bearing potential not pregnant and practice birth control * Subject and parent/guardian willing to comply with protocol * Signed consent and assent Exclusion Criteria: * Estimated Full Scale intellectual level below 80 using Wechsler Abbreviated Scale of Intelligence (WASI) * Current primary psychiatric diagnosis of other listed disorders * Chronic medical illnesses: seizure, hypertension, thyroid disease, cardiac, family history of sudden death, glaucoma * Use of psychotropic central nervous system (CNS) meds having effect exceeding 14 days from screening * Planned use of prohibited drugs * Is pregnant or breast-feeding * Significant ECG or laboratory abnormalities * Experimental drug or medical device within 30 days prior to screening * Hypersensitivity to methylphenidate * Inability or unwillingness to comply with protocol * Well controlled on current ADHD treatment * Inability to take oral capsules

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (16)

Clinical Study Centers, LLCLittle Rock, Arkansas, United States
University of California, Irvine/Child Development CenterIrvine, California, United States
Synergy ResearchNational City, California, United States
Florida Clinical Research Center, LLCBradenton, Florida, United States
Behavioral Clinical Research, Inc.Lauderhill, Florida, United States
Martin Kane, DOMaitland, Florida, United States
Segal Institute for clinical Research, North Miami Outpatient ClinicNorth Miami, Florida, United States
South Shore Psychiatric Services, PCMarshfield, Massachusetts, United States
Precise Research CenterMadison, Mississippi, United States
Center for Psychiatry and Behavioural Medicine IncLas Vegas, Nevada, United States
New York State Psychiatric Institute/Columbia UniversityNew York, New York, United States
Department of Psychiatry, Duke University Medical CenterDurham, North Carolina, United States

+ 4 more locations — full list on the registry record.

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

Little RockIrvineNational CityBradenton

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