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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00557011
Recruitment Status : Completed
First Posted : November 12, 2007
Last Update Posted : May 25, 2011
Sponsor:
Information provided by:
New River Pharmaceuticals

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Attention Deficit Disorder With Hyperactivity Drug: NRP104 Drug: Adderall XR Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (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)
Study Start Date : September 2004
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


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

Secondary Outcome Measures :
  1. SKAMP Attention Scale, PERMP attempted score, PERMP correct score, and CGI scores across the treatment assessment day [ Time Frame: 1 week ]
  2. Treatment emergent adverse events [ Time Frame: 1 week ]
  3. PK profile and PK/PD relationship of NRP104 [ Time Frame: After multiple doses ]

Eligibility Criteria
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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00557011


Sponsors and Collaborators
New River Pharmaceuticals
Investigators
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Principal Investigator: Joseph Biederman, M.D. Harvard Medical School (HMS and HSDM)
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
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Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00557011    
Other Study ID Numbers: NRP104.201
First Posted: November 12, 2007    Key Record Dates
Last Update Posted: May 25, 2011
Last Verified: May 2011
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Amphetamine
Lisdexamfetamine Dimesylate
Adderall
Central Nervous System Stimulants
 Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors