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

Information source: New River Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Attention Deficit Disorder With Hyperactivity

Intervention: NRP104 (Drug); Adderall XR (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: New River Pharmaceuticals

Official(s) and/or principal investigator(s):
Joseph Biederman, M.D., Principal Investigator, Affiliation: Harvard University
Samuel Boellner, M.D., Principal Investigator, Affiliation: Clinical Study Centers, LLC
Ann Childress, M.D., Principal Investigator, Affiliation: Center for Psychiatry and Behavioral Medicine, Inc.
Frank Lopez, M.D., Principal Investigator, Affiliation: Unaffiliated

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.

Clinical Details

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)

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

Primary outcome: SKAMP-DS scores across a treatment assessment day

Secondary outcome:

SKAMP Attention Scale, PERMP attempted score, PERMP correct score, and CGI scores across the treatment assessment day

Treatment emergent adverse events

PK profile and PK/PD relationship of NRP104

Eligibility

Minimum age: 6 Years. Maximum age: 12 Years. Gender(s): Both.

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

Locations and Contacts

Additional Information

FDA-approved label, US only

FDA Recall information

FDA Medical Product Safety Alerts

Synopsis of study results

Starting date: September 2004
Ending date: December 2004
Last updated: November 9, 2007

Page last updated: June 20, 2008

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