Time Course of Response to Methylphenidate HCl ER Capsules in Children 6 to 12 Years With ADHD in Classroom Setting

The time course of response following one dose of a new methylphenidate hydrochloride extended release capsule is studied in children 6-12 years in a simulated laboratory classroom setting. Biphentin methylphenidate hydrochloride extended release capsule has been formulated for daily dosing to provide treatment of a child with ADHD for the substantial day.

Biphentin methylphenidate hydrochloride extended release capsules is provided in multiple strengths of 10, 15, 20, 30, 40, 50, and 60 mg to be administered once daily. Once daily dosing is intended to provide treatment for the substantial day.

For current analog classroom study each eligible subject will be optimized at 15, 20, 30, or 40 mg in a timeframe of five weekly periods. In the sixth week each subject will be randomized double-blind to receive either active comparator at the optimized dose or placebo comparator treatment. The first classroom session will be held at the end of the week, when efficacy measurements including SKAMP and PERMP tests will be administered. At the beginning of the following week, the subjects will be crossed-over to the corresponding active comparator or placebo comparator treatment. The second classroom session will be held at the end of the second double-blind week, when the same efficacy measurements will be administered.

Various safety and tolerability, and quality of life assessments will be conducted.

• Attention Deficit Hyperactivity Disorder
• ADHD

• Drug: Methylphenidate Hydrochloride Extended Release Capsules
  Methylphenidate Hydrochloride Extended Release Capsules to be dosed once daily
  Other Name: Biphentin
• Drug: Placebo
  Capsule without active drug
  Other Name: Biphentin placebo

• Active Comparator: Methylphenidate HCl ER Capsules
  Methylphenidate hydrochloride extended release capsules
  Intervention: Drug: Methylphenidate Hydrochloride Extended Release Capsules
• Placebo Comparator: Capsule without active drug
  Double blind crossover assignment of the placebo comparator.
  Intervention: Drug: Placebo

Inclusion Criteria:

1. Males and females ages 6 to 12.
2. ADHD diagnosis with ADHD-RS-IV scores ≥ 90th percentile.
3. In need of treatment for ADHD and able to have 2-day washout from previous medication.
4. Females of child-bearing potential not pregnant and practice birth control.
5. Subject and parent/guardian willing to comply with protocol.
6. Signed consent and assent.

Exclusion Criteria:

1. IQ less than 80 WASI.
2. Current primary psychiatric diagnosis of: severe anxiety disorder, conduct disorder, psychotic disorders, pervasive developmental disorder, eating disorder, obsessive-compulsive disorder, major depressive disorder, bipolar disorder, substance use disorder, chronic tic disorder, personal or family history of Tourette's Syndrome.
3. Chronic medical illnesses: seizure, hypertension, thyroid disease, cardiac, family history of sudden death, glaucoma.
4. Use of psychotropic CNS meds having effect exceeding 14 days from screening.
5. Planned use of prohibited drugs.
6. Is pregnant or breast-feeding.
7. Significant ECG or laboratory abnormalities.
8. Experimental drug or medical device within 30 days prior to screening.
9. Hypersensitivity to methylphenidate.
10. Inability or unwillingness to comply with protocol.
11. Well controlled on current ADHD treatment.
12. Inability to take oral capsules.