Safety and Efficacy of Methylphenidate Transdermal System (MTS) Versus Concerta in Pediatric Patients (Aged 6-12 Years) With ADHD

Condition(s) targeted: Attention Deficit Hyperactivity Disorder

Intervention: Methylphenidate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Shire Pharmaceutical Development

This is a phase III, randomized, double-blind, multi-center, parallel-group, placebo-controlled, dose optimization study designed to evaluate the safety and efficacy of MTS (12. 5, 18. 75, 25, and 37. 5 cm2) compared to placebo with reference to CONCERTA® in pediatric subjects diagnosed with attention deficit hyperactivity disorder (ADHD).

Official title: A Phase III, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled, Dose Optimization Study, Designed to Evaluate the Safety and Efficacy of Methylphenidate Transdermal System (MTS) vs. CONCERTA® in Pediatric Patients Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD)

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: The primary objective of this study is to evaluate, under controlled conditions, the safety and efficacy of SPD485 (MTS) compared to placebo with reference to CONCERTA®, as determined by the change in the clinician completed ADHD-RS-IV at each visit.

Secondary outcome:

CTRS-R, CPRS-R, CGI, PGA scores

Treatment emergent AEs, dermal evaluations, PK

Minimum age: 6 Years. Maximum age: 12 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- male or female aged 6-12 years

- females of Child-bearing Potential (FOCP) must have a negative serum beta Human

Chorionic Gonadotropin (HCG) pregnancy test at Screening and a negative urine pregnancy test at Baseline.

- a primary diagnosis of ADHD based on a detailed psychiatric evaluation

- a total score of =>26 on the ADHD-RS-IV at the Baseline Visit

- a minimum level of intellectual functioning, as determined by an IQ (based on KBIT)

score of 80 or above

- no comorbid illness that could affect safety or tolerability or in any way interfere

with the subject's participation in the study.

EXCLUSION CRITERIA:

- a current, controlled (requiring a restricted medication) or uncontrolled, comorbid

psychiatric diagnosis (except ODD) with significant symptoms such as Post Traumatic Stress Disorder (PTSD), psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder

- a known non-responder to psychostimulant treatment

- overweight (Body Mass Index (BMI)-for-age >90th percentile)

- a history of seizures during the last 2 years (exclusive of infantile febrile

seizures), a tic disorder, a current diagnosis and/or family history of Tourette's Disorder.

- Conduct Disorder.

- Subject has taken an investigational drug within 30 days prior to Screening.

(FDA Recall Information)

(FDA Medical Product Safety Alerts)

(FDA-approved label)

(Synopsis of study results)

Starting date: September 2004
Ending date: June 2005
Last updated: February 25, 2008