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

Noven Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Attention Deficit Hyperactivity Disorder

Treatments: Drug: Concerta; Drug: Placebo; Drug: Methylphenidate Transdermal System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00444574

SPD485-302

Details and patient eligibility

About

Study designed to evaluate the safety and efficacy of MTS compared to placebo with reference to CONCERTA® in pediatric subjects diagnosed with ADHD.

Full 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).

Enrollment: 282 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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282 participants in 3 patient groups, including a placebo group

Methylphenidate Transdermal System

Active Comparator group

Description:

Methylphenidate 2.7mg, 41.3mg, 55mg, and 82.5mg patches for 7 weeks

Treatment:

Drug: Methylphenidate Transdermal System

Placebo

Placebo Comparator group

Description:

Placebp matching MTS and Concerta for 7 weeks

Treatment:

Drug: Placebo

Concerta

Active Comparator group

Description:

Methylphenidate HCL 18mg tablet 7 weeks

Treatment:

Drug: Concerta