Efficacy, Safety and Tolerability of SPD485 in Children Aged 6-12 Diagnosed With ADHD

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

A Phase IIB, Randomized, Double-blind, Multi-Center, Placebo-Controlled, Dose-Optimization, 3-way Cross-Over, Analog Classroom Study to Assess the Efficacy, Duration of Effect, Tolerability and Safety of 4- and 6- Hour Wear Times of Methylphenidate Transdermal System (MTS) in Pediatric Subjects Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00151970
• Other study ID #: SPD485-304
• Status: Completed
• Phase: Phase 2
• First received: September 7, 2005
• Last updated: July 8, 2015
• Start date: June 2005
• Est. completion date: October 2006

Study information

• Verified date: July 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

This study will assess the efficacy, duration of effect, tolerability and safety of 4- and 6- hour wear times of SPD485 in 6-12 year old subjects diagnosed with ADHD.

Description:

Attention-Deficit/Hyperactivity Disorder (ADHD) is a psychiatric disorder characterized by 3 main symptoms: inattention, hyperactivity and impulsivity. This study will assess the efficacy, duration of effect, tolerability and safety of 4- and 6- hour wear times of SPD485 in 6-12 year old subjects diagnosed with ADHD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• Subjects have primary diagnosis of ADHD

• Females of childbearing potential must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test

• Subject has an IQ score of >_ 80

• Subject is able to complete as least the Basic Test of the PERMP assessment

Exclusion Criteria:

• Subject has a comorbid psychiatric diagnosis such as Axis II disorders or severe Axis I disorders

• Subject is taking Strattera(r)

• Subject has a recent history of suspected substance abuse or dependence disorder

Study Design

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

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

Intervention

Drug:
• Methylphenidate Transdermal System
MTS 10mg/12.5cm2, 15mg/18.75cm2, 20mg/25cm2, and 30mg/37.5cm2 patch sizes
• Placebo
Placebo patch 10mg/12.5cm2, 15mg/18.75cm2, 20mg/25cm2, and 30mg/37.5cm2 patch sizes applied daily
• Concerta
CONCERTA® is available in doses of 18mg, 27mg, 36mg, 54mg, and 72mg tablets daily

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Noven Therapeutics	Noven Pharmaceuticals, Inc.

References & Publications (1)

Wilens TE, Boellner SW, López FA, Turnbow JM, Wigal SB, Childress AC, Abikoff HB, Manos MJ. Varying the wear time of the methylphenidate transdermal system in children with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2008 Jun;47(6):700-8. doi: 10.1097/CHI.0b013e31816bffdf. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SKAMP deportment rating scale		Week 8	No
Secondary	PERMP age-adjusted math test		Week 8	No
Secondary	Clinician-rated ADHD-RS-IV		Week 8	No
Secondary	CGI-I		Week 8	No
Secondary	Parent Global Assessment		Week 8	No
Secondary	Connors' Parent Rating Scale		Week 8	No
Secondary	ADHD Impact Module-Children		Week 8	No
Secondary	SKAMP-total and inattention subscales		Week 8	No

External Links

•   FDA Recall Information
•   FDA-approved Label