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

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Methylphenidate Transdermal System

Placebo

Concerta

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring Attention Deficit Hyperactivity Disorder (ADHD)

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

Methylphenidate Transdermal System

Placebo

Concerta

Arm Description

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

Placebp matching MTS and Concerta for 7 weeks

Methylphenidate HCL 18mg tablet 7 weeks

Outcomes

Primary Outcome Measures

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 Measures

CTRS-R, CPRS-R, CGI, PGA scores

Treatment emergent AEs, dermal evaluations, PK

Full Information

NCT ID

NCT00444574

First Posted

March 6, 2007

Last Updated

June 23, 2015

Sponsor

Noven Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT00444574

Brief Title

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

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Completed

Study Start Date

September 2004 (undefined)

Primary Completion Date

June 2005 (Actual)

Study Completion Date

June 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Noven Therapeutics

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Attention Deficit Hyperactivity Disorder

Keywords

Attention Deficit Hyperactivity Disorder (ADHD)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

282 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Methylphenidate Transdermal System

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebp matching MTS and Concerta for 7 weeks

Arm Title

Concerta

Arm Type

Active Comparator

Arm Description

Methylphenidate HCL 18mg tablet 7 weeks

Intervention Type

Drug

Intervention Name(s)

Methylphenidate Transdermal System

Other Intervention Name(s)

MTS

Intervention Description

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

Intervention Name(s)

Placebo

Other Intervention Name(s)

Sham treatment

Intervention Description

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

Intervention Name(s)

Concerta

Other Intervention Name(s)

Methylphenidate HCL

Intervention Description

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

Primary Outcome Measure Information:

Title

Time Frame

7 weeks

Secondary Outcome Measure Information:

Title

CTRS-R, CPRS-R, CGI, PGA scores

Time Frame

7 weeks

Title

Treatment emergent AEs, dermal evaluations, PK

Time Frame

7 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

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.

12. IPD Sharing Statement

Citations:

PubMed Identifier

18312050

Citation

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. Erratum In: J Clin Psychiatry. 2008 Feb;69(2):329.

Results Reference

result

Links:

URL

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

Description

(FDA Recall Information)

Learn more about this trial

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

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