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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rhodes Pharmaceuticals, L.P.
ClinicalTrials.gov Identifier:
NCT01239030
First received: November 3, 2010
Last updated: January 22, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
ADHD
Drug: Methylphenidate Hydrochloride Extended Release Capsules
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Rhodes Pharmaceuticals, L.P.:

Primary Outcome Measures:
  • Efficacy of Biphentin compared to placebo [ Time Frame: At end of Double-Blind Week 1 ] [ Designated as safety issue: No ]
    Efficacy of Biphentin compared to placebo, in the clinic setting, as measured by the Clinician ADHD-RS-IV in children and adolescents (aged 6 to 18) diagnosed with ADHD


Secondary Outcome Measures:
  • Incidence of Adverse Events as a Measure of Safety and Tolerability [ Time Frame: During the 12-week study period ] [ Designated as safety issue: Yes ]
    Incidence of adverse findings using various measures of safety, tolerability, and quality of life assessments following administration of once daily Biphentin


Enrollment: 236
Study Start Date: November 2010
Study Completion Date: March 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 10 mg
Biphentin Methylphenidate Hydrochloride Extended Release Capsules 10 mg
Drug: Methylphenidate Hydrochloride Extended Release Capsules
Biphentin Methylphenidate ER Once-A-Day Capsules
Other Names:
  • Biphentin
  • Methylphenidate Hydrochloride Extended Release Capsules
Active Comparator: 15 mg
Biphentin Methylphenidate Hydrochloride Extended Release Capsules 15 mg
Drug: Methylphenidate Hydrochloride Extended Release Capsules
Biphentin Methylphenidate ER Once-A-Day Capsules
Other Names:
  • Biphentin
  • Methylphenidate Hydrochloride Extended Release Capsules
Active Comparator: 20 mg
Biphentin Methylphenidate Hydrochloride Extended Release Capsules 20 mg
Drug: Methylphenidate Hydrochloride Extended Release Capsules
Biphentin Methylphenidate ER Once-A-Day Capsules
Other Names:
  • Biphentin
  • Methylphenidate Hydrochloride Extended Release Capsules
Active Comparator: 40 mg
Biphentin Methylphenidate Hydrochloride Extended Release Capsules 40 mg
Drug: Methylphenidate Hydrochloride Extended Release Capsules
Biphentin Methylphenidate ER Once-A-Day Capsules
Other Names:
  • Biphentin
  • Methylphenidate Hydrochloride Extended Release Capsules
Placebo Comparator: Placebo
Placebo Capsules
Drug: Methylphenidate Hydrochloride Extended Release Capsules
Biphentin Methylphenidate ER Once-A-Day Capsules
Other Names:
  • Biphentin
  • Methylphenidate Hydrochloride Extended Release Capsules

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

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01239030

Locations
United States, Arkansas
Clinical Study Centers, LLC
Little Rock, Arkansas, United States, 72205
United States, California
University of California, Irvine/Child Development Center
Irvine, California, United States, 92612
Synergy Research
National City, California, United States, 91950
United States, Florida
Florida Clinical Research Center, LLC
Bradenton, Florida, United States, 34201
Behavioral Clinical Research, Inc.
Lauderhill, Florida, United States, 33319
Martin Kane, DO
Maitland, Florida, United States, 32751
Segal Institute for clinical Research, North Miami Outpatient Clinic
North Miami, Florida, United States, 33161
United States, Massachusetts
South Shore Psychiatric Services, PC
Marshfield, Massachusetts, United States, 02050
United States, Mississippi
Precise Research Center
Madison, Mississippi, United States, 39110
United States, Nevada
Center for Psychiatry and Behavioural Medicine Inc
Las Vegas, Nevada, United States, 89128
United States, New York
New York State Psychiatric Institute/Columbia University
New York, New York, United States, 10032
United States, North Carolina
Department of Psychiatry, Duke University Medical Center
Durham, North Carolina, United States, 27705
CTMG
Newbern, North Carolina, United States, 28562
United States, Ohio
University of Cincinnati College of Medicine/PPSI
Cincinnati, Ohio, United States, 45219
University Hospital Case Medical Center
Cleveland, Ohio, United States, 44106
United States, Texas
Wharton Research Center, Inc.
Wharton, Texas, United States, 77488
Sponsors and Collaborators
Rhodes Pharmaceuticals, L.P.
Investigators
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.
  More Information

No publications provided

Responsible Party: Rhodes Pharmaceuticals, L.P.
ClinicalTrials.gov Identifier: NCT01239030     History of Changes
Other Study ID Numbers: RP-BP-EF002
Study First Received: November 3, 2010
Last Updated: January 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Rhodes Pharmaceuticals, L.P.:
inattention
impulsivity
hyperactivity
ADHD

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Disease
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms
Methylphenidate
Central Nervous System Agents
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014