Attention Deficit Hyperactivity Disorder
Conditions
Keywords
Attention Deficit Hyperactivity Disorder (ADHD)
Brief summary
Study designed to evaluate the safety and efficacy of MTS compared to placebo with reference to CONCERTA® in pediatric subjects diagnosed with ADHD.
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).
Interventions
The primary objective of this study was to evaluate, under controlled conditions, the safety and efficacy of MTS compared to placebo with reference to CONCERTA
DRUGPlacebo
The primary objective of this study was to evaluate, under controlled conditions, the safety and efficacy of MTS compared to placebo with reference to CONCERTA
DRUGConcerta
The primary objective of this study was to evaluate, under controlled conditions, the safety and efficacy of MTS compared to placebo with reference to CONCERTA
Sponsors
Noven Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 7 weeks |
Secondary
| Measure | Time frame |
|---|---|
| CTRS-R, CPRS-R, CGI, PGA scores | 7 weeks |
| Treatment emergent AEs, dermal evaluations, PK | 7 weeks |
Outcome results
None listed