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

NCT ID: NCT00444574

Last Updated: 2015-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 282 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2005-06-30

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).

Conditions

Attention Deficit Hyperactivity Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Methylphenidate Transdermal System

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

Group Type: ACTIVE_COMPARATOR

Methylphenidate Transdermal System

Intervention Type: DRUG

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

Placebo

Placebp matching MTS and Concerta for 7 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Concerta

Methylphenidate HCL 18mg tablet 7 weeks

Group Type: ACTIVE_COMPARATOR

Concerta

Intervention Type: DRUG

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

Interventions

Methylphenidate Transdermal System

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Concerta

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

Intervention Type: DRUG

Other Intervention Names

MTS; Sham treatment; Methylphenidate HCL

Eligibility 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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Noven Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Findling RL, Bukstein OG, Melmed RD, Lopez FA, Sallee FR, Arnold LE, Pratt RD. A randomized, double-blind, placebo-controlled, parallel-group study of methylphenidate transdermal system in pediatric patients with attention-deficit/hyperactivity disorder. J Clin Psychiatry. 2008 Jan;69(1):149-59. doi: 10.4088/jcp.v69n0120.

Reference Type: RESULT

PMID: 18312050 (View on PubMed)

Related Links

http://www.fda.gov/opacom/7alerts.html

(FDA Recall Information)

Other Identifiers

SPD485-302

Identifier Type: -

Identifier Source: org_study_id