Efficacy and Safety of Methylphenidate HCl ER Capsules in Children and Adolescents With ADHD
NCT ID: NCT01239030
Last Updated: 2023-02-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
230 participants
INTERVENTIONAL
2010-11-30
2012-03-31
Brief Summary
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Detailed Description
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The primary objective was to assess the efficacy of Biphentin compared to placebo, in the clinic setting, as measured by the clinician-administered parent version of the ADHD-RS-IV.
Subjects who met study entry criteria were enrolled in the Double-blind Phase and were randomized to either a fixed dose of Biphentin (!0, 15, 20, or 40 mg/day) or placebo capsule taken daily in the morning for 1 week. Subjects then continued into an Open-label Phase that included dose optimization with doses starting at 10 mg and allowed up to 60 mg. The open-label period following the one double-blind fixed dose week provides additional opportunity for subjects to receive treatment with Biphentin. Extra unscheduled dose optimization visits are allowed as needed for additional dose titration visits during the open-label period.
The safety and tolerability, and efficacy assessments will be conducted throughout the study.
Biphentin® is designed to be a single daily dose alternative to separate doses of immediate release methylphenidate by providing a biphasic plasma profile. It achieves a first Cmax more similar to immediate release methylphenidate.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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10 mg
Biphentin Methylphenidate Hydrochloride Extended Release Capsules 10 mg
Methylphenidate Hydrochloride Extended Release Capsules
Biphentin Methylphenidate ER Once-A-Day Capsules
15 mg
Biphentin Methylphenidate Hydrochloride Extended Release Capsules 15 mg
Methylphenidate Hydrochloride Extended Release Capsules
Biphentin Methylphenidate ER Once-A-Day Capsules
20 mg
Biphentin Methylphenidate Hydrochloride Extended Release Capsules 20 mg
Methylphenidate Hydrochloride Extended Release Capsules
Biphentin Methylphenidate ER Once-A-Day Capsules
40 mg
Biphentin Methylphenidate Hydrochloride Extended Release Capsules 40 mg
Methylphenidate Hydrochloride Extended Release Capsules
Biphentin Methylphenidate ER Once-A-Day Capsules
Placebo
Placebo capsules
Placebo
Placebo capsules
Methylphenidate HCl ER Capsules (10, 15, 20, 40, 50 or 60 mg)
Biphentin Methylphenidate Hydrochloride Extended Release Capsules (10, 15, 20, 40, 50 or 60 mg) - Open Label Phase
Methylphenidate Hydrochloride Extended Release Capsules
Biphentin Methylphenidate ER Once-A-Day Capsules
Interventions
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Methylphenidate Hydrochloride Extended Release Capsules
Biphentin Methylphenidate ER Once-A-Day Capsules
Placebo
Placebo capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Years
18 Years
ALL
No
Sponsors
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Rhodes Pharmaceuticals, L.P.
INDUSTRY
Responsible Party
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Principal Investigators
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Wei-wei Chang, Ph.D.
Role: STUDY_DIRECTOR
NuTec Incorporated
Laurence Greenhill, M.D.
Role: PRINCIPAL_INVESTIGATOR
New York State Psychiatric Institute / Columbia University
Sharon B. Wigal, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of California, Irvine / Child Development Center
Robert J. Kupper, Ph.D.
Role: STUDY_CHAIR
Rhodes Phamaceuticals, L.P.
Locations
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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
Countries
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References
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Wigal SB, Nordbrock E, Adjei AL, Childress A, Kupper RJ, Greenhill L. Efficacy of Methylphenidate Hydrochloride Extended-Release Capsules (Aptensio XR) in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder: A Phase III, Randomized, Double-Blind Study. CNS Drugs. 2015 Apr;29(4):331-40. doi: 10.1007/s40263-015-0241-3.
Other Identifiers
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RP-BP-EF002
Identifier Type: -
Identifier Source: org_study_id
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