Efficacy and Safety of Methylphenidate HCl ER Capsules in Children and Adolescents With ADHD
- Conditions
- Attention Deficit Hyperactivity DisorderADHD
- Interventions
- Registration Number
- NCT01239030
- Lead Sponsor
- Rhodes Pharmaceuticals, L.P.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 230
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 15 mg Methylphenidate Hydrochloride Extended Release Capsules Biphentin Methylphenidate Hydrochloride Extended Release Capsules 15 mg 20 mg Methylphenidate Hydrochloride Extended Release Capsules Biphentin Methylphenidate Hydrochloride Extended Release Capsules 20 mg 40 mg Methylphenidate Hydrochloride Extended Release Capsules Biphentin Methylphenidate Hydrochloride Extended Release Capsules 40 mg Methylphenidate HCl ER Capsules (10, 15, 20, 40, 50 or 60 mg) Methylphenidate Hydrochloride Extended Release Capsules Biphentin Methylphenidate Hydrochloride Extended Release Capsules (10, 15, 20, 40, 50 or 60 mg) - Open Label Phase 10 mg Methylphenidate Hydrochloride Extended Release Capsules Biphentin Methylphenidate Hydrochloride Extended Release Capsules 10 mg Placebo Placebo Placebo capsules
- Primary Outcome Measures
Name Time Method Change in ADHD-RS-IV Total Score From Baseline (Visit 2) to the End of the Double-Blind Phase (Visit 3) From baseline (visit 2) to end of of 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (16)
Center for Psychiatry and Behavioural Medicine Inc
🇺🇸Las Vegas, Nevada, United States
University of Cincinnati College of Medicine/PPSI
🇺🇸Cincinnati, Ohio, United States
Florida Clinical Research Center, LLC
🇺🇸Bradenton, Florida, United States
Synergy Research
🇺🇸National City, California, United States
CTMG
🇺🇸New Bern, North Carolina, United States
Wharton Research Center, Inc.
🇺🇸Wharton, Texas, United States
University Hospital Case Medical Center
🇺🇸Cleveland, Ohio, United States
University of California, Irvine/Child Development Center
🇺🇸Irvine, California, United States
Martin Kane, DO
🇺🇸Maitland, Florida, United States
Segal Institute for clinical Research, North Miami Outpatient Clinic
🇺🇸North Miami, Florida, United States
Precise Research Center
🇺🇸Madison, Mississippi, United States
New York State Psychiatric Institute/Columbia University
🇺🇸New York, New York, United States
South Shore Psychiatric Services, PC
🇺🇸Marshfield, Massachusetts, United States
Behavioral Clinical Research, Inc.
🇺🇸Lauderhill, Florida, United States
Department of Psychiatry, Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Clinical Study Centers, LLC
🇺🇸Little Rock, Arkansas, United States