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

Sponsor:	New River Pharmaceuticals
Information provided by:	New River Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00557011

Purpose

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.

Condition	Intervention	Phase
Attention Deficit Disorder With Hyperactivity	Drug: NRP104 Drug: Adderall XR Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	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)

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Lisdexamfetamine Lisdexamfetamine dimesylate

U.S. FDA Resources

Further study details as provided by New River Pharmaceuticals:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	52
Study Start Date:	September 2004
Study Completion Date:	December 2004

Arms	Assigned Interventions
1: Experimental NRP104	Drug: NRP104 30 mg, 50 mg or 70 mg capsules taken orally once daily in the morning
2: Active Comparator Adderall XR	Drug: Adderall XR 10 mg capsules taken once daily in the morning at dosages of either 1x10mg, 2x10mg or 3x10mg
3: Placebo Comparator Placebo	Drug: Placebo Placebo capsule taken once daily in the morning

Eligibility

Ages Eligible for Study:	6 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00557011

Sponsors and Collaborators

New River Pharmaceuticals

Investigators

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

More Information

Additional Information:

FDA-approved label, US only This link exits the ClinicalTrials.gov site

FDA Recall information This link exits the ClinicalTrials.gov site

FDA Medical Product Safety Alerts This link exits the ClinicalTrials.gov site

Synopsis of study results This link exits the ClinicalTrials.gov site

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.

Study ID Numbers:	NRP104.201
Study First Received:	November 9, 2007
Last Updated:	November 13, 2008
ClinicalTrials.gov Identifier:	NCT00557011 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Disease
Adderall
Physiological Effects of Drugs
Nervous System Diseases
Attention Deficit and Disruptive Behavior Disorders
Central Nervous System Stimulants
Dyskinesias
Pharmacologic Actions
Signs and Symptoms

Pathologic Processes
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Therapeutic Uses
Mental Disorders Diagnosed in Childhood
Hyperkinesis
Neurologic Manifestations
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009