A Phase IIIb, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled, Dose Optimization Study, Designed to Evaluate the Efficacy and Safety of MTS in Adolescents Aged 13-17 Years With ADHD

Noven Therapeutics30 sites in 1 country217 target enrollmentJuly 2007

ConditionsADHD

Interventionsmethylphenidate transdermal system Placebo

Drugsmethylphenidate transdermal system Placebo

Overview

Phase: Phase 3
Intervention: methylphenidate transdermal system
Conditions: ADHD
Sponsor: Noven Therapeutics
Enrollment: 217
Locations: 30
Primary Endpoint: Change From Baseline in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Endpoint
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

To assess the efficacy and safety of efficacy of MTS compared to placebo

Detailed Description

To assess the efficacy and safety of efficacy of MTS compared to placebo, as determined by the change in the clinician completed ADHD Rating Scale - Version 4th Edition (ADHD-RS-IV), in the symptomatic treatment of adolescents (aged 13-17 years) diagnosed with ADHD.

Registry

clinicaltrials.gov

Start Date

July 2007

End Date

May 2008

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Noven Therapeutics

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject must meet criteria for a primary diagnosis of ADHD based on a detailed psychiatric evaluation.
•Subject must have a total score of ≥26 on the ADHD-RS-IV at the Baseline Visit (Visit 2).
•Subject must have a minimum level of intellectual functioning, as determined by an IQ (based on Kaufman Brief Intelligence Test \[KBIT\]) score of 80 or above.
•Subject has blood pressure measurements within the 95th percentile for age, gender, and height at Screening and Baseline.
•Subject is a male or female aged 13 17 years.
•Females must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test at Screening and a negative urine pregnancy test at Baseline and agree to use acceptable contraceptives throughout the study period and for 30 days after the last dose of IP.

Exclusion Criteria

•Subject has a current, controlled (requiring a restricted medication) or uncontrolled, with significant symptoms such as Post Traumatic Stress Disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder.
•Subjects who, in the opinion of the Investigator, are acutely at risk for suicidal or violent behavior towards him/herself or others, or a history of a suicide attempt requiring medical intervention.
•Subject is overweight.
•Subject has a history of seizures during the last 2 years, a tic disorder, a current diagnosis and/or family history of Tourette's Disorder.
•Subject has Conduct Disorder.
•Subject has a positive urine drug or alcohol result at Screening (with the exception of subject's current stimulant therapy, if any).
•Subject has a history of alcohol or other substance abuse or dependence.
•Subject has taken an investigational drug within 30 days prior to screening.
•Subject has any abnormal thyroid function.
•Subject has any clinically significant laboratory abnormalities.

Arms & Interventions

Methylphenidate Transdermal System

dose optimization of 4 doses of the MTS transdermal patch over the same duration of wear

Intervention: methylphenidate transdermal system

2

Daily application of matching MTS Placebo Patch

Intervention: Placebo

Outcomes

Primary Outcomes

Change From Baseline in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Endpoint

Time Frame: baseline and endpoint (up to 7 weeks)

The Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.

Secondary Outcomes

Change From Baseline in the Conner's Parent Rating Scale-Revised (CPRS-R) Total Score at Endpoint(Baseline and endpoint (up to 7 weeks))
Improvement in Clinical Global Impressions-Improvement (CGI-I) Score(up to 7 weeks)
Improvement in Parent Global Assessment (PGA) Score(up to 7 weeks)
Change From Baseline in Youth Quality of Life-research Version (YQOL-R) Total Score at Endpoint(Baseline and endpoint (up to 7 weeks))
Dermal Response Scale (DRS) Scores(up to 7 weeks)
Change From Baseline in Electrocardiogram Results(QTcF Interval) at Endpoint(Baseline and endpoint (up to 7 weeks))
Change From Baseline in Pulse Rate at Endpoint(Baseline and endpoint (up to 7 weeks))
Change From Baseline in Systolic Blood Pressure at Endpoint(Baseline and endpoint (up to 7 weeks))
Change From Baseline in Diastolic Blood Pressure at Endpoint(Baseline and endpoint (up to 7 weeks))
Change From Baseline in Weight at Endpoint(Baseline and endpoint (up to 7 weeks))