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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

Page last updated: August 23, 2015

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