Efficacy and Safety of Methylphenidate HCl ER Capsules in Children and Adolescents With ADHD
A Randomized, Parallel, Double-Blind Efficacy and Safety Study of Biphentin Methylphenidate HCl Extended Release Capsules Compared to Placebo in Children and Adolescents 6 to 18 Years With Attention Deficit Hyperactivity Disorder (ADHD)
1 other identifier
interventional
230
1 country
16
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2010
Shorter than P25 for phase_3
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 3, 2010
CompletedFirst Posted
Study publicly available on registry
November 11, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedResults Posted
Study results publicly available
February 22, 2023
CompletedFebruary 22, 2023
January 1, 2023
1.3 years
November 3, 2010
March 1, 2016
January 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in ADHD-RS-IV Total Score From Baseline (Visit 2) to the End of the Double-Blind Phase (Visit 3)
Change in ADHD-RS-IV Total Score from Baseline (Visit 2) to end of Double Blind Phase (Visit 3); \[Calculations of baseline values (Visit 2) minus end of Double Blind values (Visit 3), higher differences means better outcomes\]. Attention Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV): The home version of the ADHD-RS-IV comprising symptoms of ADHD was used. This 18-item scale incorporates each of the ADHD symptoms regardless of assigned subtype. Trained clinicians administered questionnaire to parents. Scoring was based on symptom severity on a 4-point scale: 0=never or rarely, 1=sometimes, 2=often, and 3=very often. The Total Score is the sum of the scores for all 18 items, and could range from 0 (no impairment) to 54 (maximal impairment).
From baseline (visit 2) to end of of Double-Blind phase (visit 3)
Study Arms (6)
10 mg
ACTIVE COMPARATORBiphentin Methylphenidate Hydrochloride Extended Release Capsules 10 mg
15 mg
ACTIVE COMPARATORBiphentin Methylphenidate Hydrochloride Extended Release Capsules 15 mg
20 mg
ACTIVE COMPARATORBiphentin Methylphenidate Hydrochloride Extended Release Capsules 20 mg
40 mg
ACTIVE COMPARATORBiphentin Methylphenidate Hydrochloride Extended Release Capsules 40 mg
Placebo
PLACEBO COMPARATORPlacebo capsules
Methylphenidate HCl ER Capsules (10, 15, 20, 40, 50 or 60 mg)
EXPERIMENTALBiphentin Methylphenidate Hydrochloride Extended Release Capsules (10, 15, 20, 40, 50 or 60 mg) - Open Label Phase
Interventions
Biphentin Methylphenidate ER Once-A-Day Capsules
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Clinical Study Centers, LLC
Little Rock, Arkansas, 72205, United States
University of California, Irvine/Child Development Center
Irvine, California, 92612, United States
Synergy Research
National City, California, 91950, United States
Florida Clinical Research Center, LLC
Bradenton, Florida, 34201, United States
Behavioral Clinical Research, Inc.
Lauderhill, Florida, 33319, United States
Martin Kane, DO
Maitland, Florida, 32751, United States
Segal Institute for clinical Research, North Miami Outpatient Clinic
North Miami, Florida, 33161, United States
South Shore Psychiatric Services, PC
Marshfield, Massachusetts, 02050, United States
Precise Research Center
Madison, Mississippi, 39110, United States
Center for Psychiatry and Behavioural Medicine Inc
Las Vegas, Nevada, 89128, United States
New York State Psychiatric Institute/Columbia University
New York, New York, 10032, United States
Department of Psychiatry, Duke University Medical Center
Durham, North Carolina, 27705, United States
CTMG
New Bern, North Carolina, 28562, United States
University of Cincinnati College of Medicine/PPSI
Cincinnati, Ohio, 45219, United States
University Hospital Case Medical Center
Cleveland, Ohio, 44106, United States
Wharton Research Center, Inc.
Wharton, Texas, 77488, United States
Related Publications (1)
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.
PMID: 25877989DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Akwete Adjei, PhD
- Organization
- Rhodes Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Wei-wei Chang, Ph.D.
NuTec Incorporated
- PRINCIPAL INVESTIGATOR
Laurence Greenhill, M.D.
New York State Psychiatric Institute / Columbia University
- PRINCIPAL INVESTIGATOR
Sharon B. Wigal, Ph.D.
University of California, Irvine / Child Development Center
- STUDY CHAIR
Robert J. Kupper, Ph.D.
Rhodes Phamaceuticals, L.P.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2010
First Posted
November 11, 2010
Study Start
November 1, 2010
Primary Completion
February 1, 2012
Study Completion
March 1, 2012
Last Updated
February 22, 2023
Results First Posted
February 22, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share