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

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rhodes Pharmaceuticals, L.P.
• Treatments: Methylphenidate

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