NRP104, Adderall XR or Placebo in Children Aged 6-12 Years With ADHD - Tabular View

Tracking Information

First Received Date ^ICMJE

November 9, 2007

Last Updated Date

November 13, 2008

Start Date ^ICMJE

September 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

SKAMP-DS scores across a treatment assessment day [ Time Frame: 1 week ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00557011 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

SKAMP Attention Scale, PERMP attempted score, PERMP correct score, and CGI scores across the treatment assessment day [ Time Frame: 1 week ]
Treatment emergent adverse events [ Time Frame: 1 week ]
PK profile and PK/PD relationship of NRP104 [ Time Frame: After multiple doses ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

NRP104, Adderall XR or Placebo in Children Aged 6-12 Years With ADHD

Official Title ^ICMJE

A Phase 2, Randomized, Double-Blind, Placebo- and Active-Controlled, 3-Treatment, 3-Period, Crossover Study With One Week Per Treatment and Once-a-Day Dosing of Either NRP104, Adderall XR, or Placebo in Children Aged 6 to 12 Years With Attention-Deficit Hyperactivity Disorder (ADHD)

Brief Summary

The purpose of this study is to assess, in a controlled environment, the efficacy and safety of NRP104 and Adderall XR compared to placebo in treatment of children, aged 6-12, with ADHD.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study

Condition ^ICMJE

Attention Deficit Disorder With Hyperactivity

Intervention ^ICMJE

Drug: NRP104
Drug: Adderall XR
Drug: Placebo

Study Arms / Comparison Groups

Experimental: NRP104
Active Comparator: Adderall XR
Placebo Comparator: Placebo

Publications *

Biederman J, Boellner SW, Childress A, Lopez FA, Krishnan S, Zhang Y. Lisdexamfetamine Dimesylate and Mixed Amphetamine Salts Extended-Release in Children with ADHD: A Double-Blind, Placebo-Controlled, Crossover Analog Classroom Study. Biol Psychiatry. 2007 Nov 1;62(9):970-6. Epub 2007 Jul 12.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

males and non-pregnant females, aged 6-12 years DSM-IV-TR criteria for diagnosis of ADHD, combined or hyperactive-impulsive subtypes
on stable regimen of stimulants for at least one month in the last six months and has shown adequate response to stimulants without unacceptable side effects

Exclusion Criteria:

co-morbid psychiatric diagnosis such as psychosis, bipolar illness, severe OCD, severe depressive or anxiety disorder
history of seizure during the last 2 years, a tic disorder or Tourette's
clinically significant ECG or laboratory abnormalities at screening or baseline
taking clonidine or anticonvulsant drugs
taking medications that affect blood pressure or heart rate

Gender

Both

Ages

6 Years to 12 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00557011

Responsible Party

Study ID Numbers ^ICMJE

NRP104.201

Study Sponsor ^ICMJE

New River Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:	Joseph Biederman, M.D.	Harvard University
Principal Investigator:	Samuel Boellner, M.D.	Clinical Study Centers, LLC
Principal Investigator:	Ann Childress, M.D.	Center for Psychiatry and Behavioral Medicine, Inc.
Principal Investigator:	Frank Lopez, M.D.	Unaffiliated

Information Provided By

New River Pharmaceuticals

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP