Classroom Study to Assess Efficacy and Safety of MTS in Pediatric Patients Aged 6-12 With ADHD

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

A Phase II, Randomized, Double-blind, Multi-center, Placebo-controlled, Dose Optimization, Analog Classroom, Crossover Study Designed to Assess the Time Course of Treatment Effect, Tolerability and Safety of Methylphenidate Transdermal System (MTS) in Pediatric Patients Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00466791
• Other study ID #: SPD485-201
• Status: Completed
• Phase: Phase 2
• First received: April 25, 2007
• Last updated: June 23, 2015
• Start date: August 2004
• Est. completion date: May 2005

Study information

• Verified date: June 2015
• Source: Noven Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Evaluate the behavioral effects of MTS in children aged 6-12 with ADHD

Description:

Evaluate the behavioral effects measured by the SKAMP deportment scale of MTS compared to placebo in children aged 6-12 with ADHD

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: May 2005
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• Primary diagnosis ADHD

• Total score of greater than or equal to 26 on ADHD-RS-IV

• IQ of greater than or equal to 80

• Blood pressure measurements within 95th percentile for age, gender, height at screening and baseline

Exclusion Criteria:

• Current controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis (except ODD)

• Known nonresponder to psychostimulant treatment

• BMI for age greater than 90th percentile

• History of seizures during last 2 years

• Conduct Disorder

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

Intervention

Drug:
• Methylphenidate Transdermal System
Placebo

Locations

Country	Name	City	State
United States	UCI Child Development Center	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
Noven Therapeutics

Country where clinical trial is conducted

United States, 

References & Publications (1)

McGough JJ, Wigal SB, Abikoff H, Turnbow JM, Posner K, Moon E. A randomized, double-blind, placebo-controlled, laboratory classroom assessment of methylphenidate transdermal system in children with ADHD. J Atten Disord. 2006 Feb;9(3):476-85. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score on SKAMP rating scale at 2,3,4.5,6,7.5,9,10.5 and 12 hours post application of MTS		2,3,4.5,6,7.5,9,10.5 and 12 hours	No
Secondary	PERMP scores		pre-dose, 2.0, 3.0, 4.5, 6.0, 7.5, 9.0, 10.5 and 12.0 hours post application	No
Secondary	Clinician-rated ADHD-RS-IV score		2,3,4.5,6,7.5,9,10.5 and 12 hours	No
Secondary	CGI-I score		Weeks 1-9	No
Secondary	PGA		Weeks 1-9	No
Secondary	CPRS-R score		Weeks 1-9	No

External Links

•   FDA Recall information
•   FDA-approved labelling information, US only