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

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.

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.

• Attention Deficit Hyperactivity Disorder
• ADHD

• Active Comparator: Methylphenidate HCl ER 10 mg capsules
  Intervention: Drug: Biphentin Methylphenidate Extended Release Capsules
• Active Comparator: Methylphenidate HCl ER 15 mg capsules
  Intervention: Drug: Biphentin Methylphenidate Extended Release Capsules
• Active Comparator: Methylphenidate HCl ER 20 mg capsules
  Intervention: Drug: Biphentin Methylphenidate Extended Release Capsules
• Active Comparator: Methylphenidate HCl ER 40 mg capsules
  Intervention: Drug: Biphentin Methylphenidate Extended Release Capsules
• Placebo Comparator: Placebo capsules
  Intervention: Drug: Biphentin Methylphenidate Extended Release Capsules

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