Efficacy and Safety of Methylphenidate HCl ER Capsules in Children and Adolescents With ADHD
Information source: Rhodes Pharmaceuticals, L.P.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Attention Deficit Hyperactivity Disorder; ADHD
Intervention: Methylphenidate Hydrochloride Extended Release Capsules (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Rhodes Pharmaceuticals, L.P. Official(s) and/or principal investigator(s): Wei-wei Chang, Ph.D., Study Director, Affiliation: NuTec Incorporated Laurence Greenhill, M.D., Principal Investigator, Affiliation: New York State Psychiatric Institute / Columbia University Sharon B. Wigal, Ph.D., Principal Investigator, Affiliation: University of California, Irvine / Child Development Center Robert J. Kupper, Ph.D., Study Chair, Affiliation: Rhodes Phamaceuticals, L.P.
Summary
This multi-center parallel study is designed to study the efficacy and safety of fixed doses
of methylphenidate extended release (ER)capsules of three dose levels compared with a
placebo group in pediatric patients with Attention Deficit Hyperactivity Disorder (ADHD) who
are between 6 and 18 years old.
Clinical Details
Official title: 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)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Efficacy of Biphentin compared to placebo
Secondary outcome: Incidence of Adverse Events as a Measure of Safety and Tolerability
Detailed description:
This is a parallel, randomized, double-blind, multi-center, placebo-controlled, forced dose,
phase 3 study to evaluate the safety and efficacy of Biphentin methylphenidate
hydrochloride extended release capsules in the treatment of Attention Deficit Hyperactivity
Disorder (ADHD) in pediatric and adolescent patients aged 6 up to 18 years.
The study will have four phases: (1) Screening and washout; (2) Double-blind fixed dose
study involving test drug at 10, 15, 20 or 40 mg/day or placebo for 1 week; (3) Open-label
phase that includes dose optimization with doses starting at 10 mg, and allowed up to 60 mg;
and (4) 30-day safety follow-up. Eight (8) visits may be required. 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.
Various safety and tolerability, and quality of life assessments will be conducted.
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. It also comes in eight (8), that allow
better individualized dosing.
Eligibility
Minimum age: 6 Years.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Males and females ages 6 up to 18
- ADHD diagnosis with ADHD-RS-IV 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:
- IQ less than 80 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
Locations and Contacts
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, Newbern, 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
Additional Information
Starting date: November 2010
Last updated: January 22, 2013
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