Safety and Efficacy of MTS Versus Concerta in Pediatric Patients (Aged 6-12 Years) With ADHD
Information source: Noven Therapeutics
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Attention Deficit Hyperactivity Disorder
Intervention: Methylphenidate Transdermal System (Drug); Placebo (Drug); Concerta (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Noven Therapeutics
Summary
Study designed to evaluate the safety and efficacy of MTS compared to placebo with reference
to CONCERTA® in pediatric subjects diagnosed with ADHD.
Clinical Details
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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 scoresTreatment emergent AEs, dermal evaluations, PK
Detailed description:
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).
Eligibility
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.
Locations and Contacts
Additional Information
(FDA Recall Information) (FDA-approved label)
Starting date: September 2004
Last updated: June 23, 2015
|