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

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

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

Criteria

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.