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

This study has been completed.
Sponsor:
Information provided by:
New River Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00557011
First received: November 9, 2007
Last updated: May 23, 2011
Last verified: May 2011
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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:


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
Experimental: 1
NRP104
Drug: NRP104
30 mg, 50 mg or 70 mg capsules taken orally once daily in the morning
Other Name: lisdexamfetamine dimesylate
Active Comparator: 2
Adderall XR
Drug: Adderall XR
10 mg capsules taken once daily in the morning at dosages of either 1x10mg, 2x10mg or 3x10mg
Other Name: mixed salts of a single-entity amphetamine
Placebo Comparator: 3
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Medical School
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.
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00557011     History of Changes
Other Study ID Numbers: NRP104.201
Study First Received: November 9, 2007
Last Updated: May 23, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Disease
Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Adderall
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014