Safety and Efficacy of Methylphenidate Transdermal System (MTS) Versus Concerta in Pediatric Patients (Aged 6-12 Years) With ADHD
Information source: Shire Pharmaceutical Development
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Attention Deficit Hyperactivity Disorder
Intervention: Methylphenidate (Drug)
Phase: Phase 3
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.
CTRS-R, CPRS-R, CGI, PGA scores
Treatment emergent AEs, dermal evaluations, PK
Minimum age: 6 Years.
Maximum age: 12 Years.
- 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.
- 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
- Conduct Disorder.
- Subject has taken an investigational drug within 30 days prior to Screening.
Locations and Contacts
(FDA Recall Information)
(FDA Medical Product Safety Alerts)
(Synopsis of study results)
Starting date: September 2004
Ending date: June 2005
Last updated: February 25, 2008