NCT00141050

CompletedPhase 3

Safety and Efficacy Study of Dexmethylphenidate in Children ...

Novartis Source

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Other study identifiers

Sponsor study identifier

CRIT124EUS12

Study Type

interventional

Reported enrollment (type unavailable)

90

Locations

1 country

Sites

1

Timeline

Study Start

May 2005

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

July 2005

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): 90 participants
Study completion date: July 2005
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
May 2005
Date type not reported
This date has not been verified as actual or estimated.
Study Completion
July 2005
Actual (reported)
First Submitted
August 30, 2005
Actual (reported)
First Posted
September 1, 2005
Actual (reported)

Last Updated: December 21, 2007
Status Verified: December 2007
Last Update Submitted: December 17, 2007

Conditions

ADHD

Keywords

ADHD, children

Outcome Measures

Primary Outcomes (1)

Change in attention and deportment measured at 2 hours post-dose

Secondary Outcomes (3)

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
Safety and tolerability of two doses of dexmethylphenidate compared to two doses of an approved, long-acting, marketed medication for ADHD and placebo in children ages 6-12 diagnosed with ADHD.

Interventions

Focalin XRDrug

Eligibility Criteria

Age6 Years - 12 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

Sponsors & Collaborators

Novartis
Industrylead

Study Sites (1)

Bayou City Research

Houston, Texas, 77007, United States

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Dexmethylphenidate Hydrochloride

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

MethylphenidatePhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-Ring

Study Officials

Matthew Brams, MD
Bayou City Research
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: DOUBLE
Purpose: PREVENTION
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

August 30, 2005

First Posted

September 1, 2005

Study Start

May 2005

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

July 2005

Actual (reported)

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Phase 3Completed

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Phase 3Completed

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Phase 3Completed

NCT00393042

Sleep and Tolerability Study: Comparing the Effects of Adderall XR and Focalin XR

Phase 3Completed

NCT00334880

Study to Assess the Safety and Efficacy of NRP104 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)

Phase 3Completed

NCT00343811

Study to Evaluate the Efficacy of Modafinil Treatment in Patients With Attention Deficit Hyperactivity Disorder (ADHD) Who Are Responders to Modafinil Treatment

Phase 3Completed

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

Contact the study team to confirm eligibility.

Heterocyclic Compounds

Last Updated

December 21, 2007

Record last verified: 2007-12

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00141050
Data provider: ClinicalTrials.gov
Source updated: 2007-12-21
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:39:08 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Source record

Locations