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

Completed · Phase 3 · Has a placebo group

Conditions studied: Attention Deficit Hyperactivity Disorder, ADHD

In brief

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.

Key facts

Study ID

NCT01239030

Run by

Rhodes Pharmaceuticals, L.P.

People needed

230

Starts

2010-11-01

Expected to finish

2012-03-01

Last updated by the study team

2023-02-22

Who can join

Age: 6 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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