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

This study has been completed.
Information provided by:
New River Pharmaceuticals Identifier:
First received: November 9, 2007
Last updated: May 23, 2011
Last verified: May 2011
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
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Care Provider, 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
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
Drug: Placebo
Placebo capsule taken once daily in the morning


Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00557011

Sponsors and Collaborators
New River Pharmaceuticals
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 automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00557011     History of Changes
Other Study ID Numbers: NRP104.201
Study First Received: November 9, 2007
Last Updated: May 23, 2011

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Lisdexamfetamine Dimesylate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents processed this record on April 24, 2017