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 dayTreatment 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
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