Safety and Efficacy Study of Dexmethylphenidate in Childr... | NCT00141050

Studies
Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD

NCT00141050

Sponsor

Novartis

Status

Completed

Last Update Posted

Dec 21, 2007Estimated

Enrollment

Phase

Phase 3

Conditions

ADHD

Interventions

Focalin XR

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

May 2005

Primary Completion Date

Not provided

Completion Date

Jul 2005Actual

First Submitted Date

Aug 30, 2005

First Submission Date that Met QC Criteria

Aug 30, 2005

First Posted Date

Sep 1, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2007

Last Update Posted Date

Dec 21, 2007Estimated

Description Module

Brief Summary

The purpose of this study is to compare the safety and efficacy of two doses of dexmethylphenidate to two doses of an approved, long-acting, marketed medication for ADHD (MPH) and placebo in children ages 6-12 diagnosed with ADHD.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Focalin XR	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in attention and deportment measured at 2 hours post-dose

Secondary Outcomes

Measure	Description	Time Frame
Onset of effect at 0.5, 1, 2, 3, 4, 6, 8, 10, 11, and 12 hours post-dose
Parent's assessment of patient behavior across all treatment periods as measured by the change from baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

DSM-IV diagnosis of ADHD
Males and females aged 6-12

Exclusion Criteria:

Inability to understand or follow instructions
Is pregnant
Diagnosis of tic disorder
History of seizure disorder

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matthew Brams, MD	Bayou City Research	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bayou City Research		Houston	Texas	77007	United States

Condition Browse Module

MeSH Terms

ID	Term
D001289	Attention Deficit Disorder with Hyperactivity

Ancestor Terms

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D064699	Dexmethylphenidate Hydrochloride

Ancestor Terms

ID	Term
D008774	Methylphenidate
D010648	Phenylacetates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids

Browse Leaves

Not provided

Browse Branches

Not provided