Clinical trial NCT01239030: Efficacy and Safety of Methylphenidate HCl ER Capsules in Children and Adolescents With ADHD
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Attention Deficit Hyperactivity Disorder
ADHD
Keywords: inattention
impulsivity
hyperactivity
ADHD
Lead sponsor: Rhodes Pharmaceuticals, L.P.
Sponsor class: INDUSTRY
First posted: 2010-11-11
Enrollment: 230
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 (HCl) extended release (ER) capsules in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric and adolescent patients aged 6 up to 18 years.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in ADHD-RS-IV Total Score From Baseline (Visit 2) to the End of the Double-Blind Phase (Visit 3)
timeFrame: From baseline (visit 2) to end of of Double-Blind phase (visit 3)
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Clinical Study Centers, LLC
state: Arkansas
city: Irvine
country: United States
facility: University of California, Irvine/Child Development Center
state: California
city: National City
country: United States
facility: Synergy Research
state: California
city: Bradenton
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
city: Lauderhill
country: United States
facility: Behavioral Clinical Research, Inc.
state: Florida
city: Maitland
country: United States
facility: Martin Kane, DO
state: Florida
city: North Miami
country: United States
facility: Segal Institute for clinical Research, North Miami Outpatient Clinic
state: Florida
city: Marshfield
country: United States
facility: South Shore Psychiatric Services, PC
state: Massachusetts
city: Madison
country: United States
facility: Precise Research Center
state: Mississippi
city: Las Vegas
country: United States
facility: Center for Psychiatry and Behavioural Medicine Inc
state: Nevada
city: New York
country: United States
facility: New York State Psychiatric Institute/Columbia University
state: New York
city: Durham
country: United States
facility: Department of Psychiatry, Duke University Medical Center
state: North Carolina
city: New Bern
country: United States
facility: CTMG
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati College of Medicine/PPSI
state: Ohio
city: Cleveland
country: United States
facility: University Hospital Case Medical Center
state: Ohio
city: Wharton
country: United States
facility: Wharton Research Center, Inc.
state: Texas
Study officials:
affiliation: NuTec Incorporated
name: Wei-wei Chang, Ph.D.
role: STUDY_DIRECTOR
affiliation: New York State Psychiatric Institute / Columbia University
name: Laurence Greenhill, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Irvine / Child Development Center
name: Sharon B. Wigal, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rhodes Phamaceuticals, L.P.
name: Robert J. Kupper, Ph.D.
role: STUDY_CHAIR
References:
citation: 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.