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

Recruiting in Palo Alto (17 mi)

+16 other locations

Overseen by Laurence Greenhill, M.D.

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Rhodes Pharmaceuticals, L.P.

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Inclusion Criteria

You have been diagnosed with Attention Deficit Hyperactivity Disorder and scored in the 90th percentile or higher on the ADHD Rating Scale - 4th Edition.

You are between the ages of 6 and 18, regardless of gender.

You are in need of treatment for Attention Deficit Hyperactivity Disorder and have abstained from prior medication for a minimum of 2 days.

Treatment Details

Interventions

• Methylphenidate Hydrochloride Extended Release Capsules (CNS Stimulant)
• Placebo (Other)

Participant Groups

Group I: Methylphenidate HCl ER Capsules (10, 15, 20, 40, 50 or 60 mg) Experimental Treatment 1 Intervention

Biphentin Methylphenidate Hydrochloride Extended Release Capsules (10, 15, 20, 40, 50 or 60 mg) - Open Label Phase

Group II: 10 mg Active Control 1 Intervention

Biphentin Methylphenidate Hydrochloride Extended Release Capsules 10 mg

Group III: 15 mg Active Control 1 Intervention

Biphentin Methylphenidate Hydrochloride Extended Release Capsules 15 mg

Group IV: 20 mg Active Control 1 Intervention

Biphentin Methylphenidate Hydrochloride Extended Release Capsules 20 mg

Group V: 40 mg Active Control 1 Intervention

Biphentin Methylphenidate Hydrochloride Extended Release Capsules 40 mg

Group VI: Placebo Placebo Group 2 Interventions

Placebo capsules

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Center for Psychiatry and Behavioural Medicine Inc Las Vegas, NV

South Shore Psychiatric Services, PC Marshfield, MA

CTMG New Bern, NC

Wharton Research Center, Inc. Wharton, TX

More Trial Locations

Who Is Running the Clinical Trial?

Rhodes Pharmaceuticals, L.P. Lead Sponsor

References