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

Primary Purpose

Attention Deficit Disorder With Hyperactivity

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
NRP104
Adderall XR
Placebo
Sponsored by
New River Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Placebo Comparator

    Arm Label

    1

    2

    3

    Arm Description

    NRP104

    Adderall XR

    Placebo

    Outcomes

    Primary Outcome Measures

    SKAMP-DS scores across a treatment assessment day

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    November 9, 2007
    Last Updated
    May 23, 2011
    Sponsor
    New River Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00557011
    Brief Title
    NRP104, Adderall XR or Placebo in Children Aged 6-12 Years With ADHD
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    December 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    New River Pharmaceuticals

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Attention Deficit Disorder With Hyperactivity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    52 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    NRP104
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    Adderall XR
    Arm Title
    3
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    NRP104
    Other Intervention Name(s)
    lisdexamfetamine dimesylate
    Intervention Description
    30 mg, 50 mg or 70 mg capsules taken orally once daily in the morning
    Intervention Type
    Drug
    Intervention Name(s)
    Adderall XR
    Other Intervention Name(s)
    mixed salts of a single-entity amphetamine
    Intervention Description
    10 mg capsules taken once daily in the morning at dosages of either 1x10mg, 2x10mg or 3x10mg
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo capsule taken once daily in the morning
    Primary Outcome Measure Information:
    Title
    SKAMP-DS scores across a treatment assessment day
    Time Frame
    1 week
    Secondary Outcome Measure Information:
    Title
    SKAMP Attention Scale, PERMP attempted score, PERMP correct score, and CGI scores across the treatment assessment day
    Time Frame
    1 week
    Title
    Treatment emergent adverse events
    Time Frame
    1 week
    Title
    PK profile and PK/PD relationship of NRP104
    Time Frame
    After multiple doses

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Joseph Biederman, M.D.
    Organizational Affiliation
    Harvard Medical School (HMS and HSDM)
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Samuel Boellner, M.D.
    Organizational Affiliation
    Clinical Study Centers, LLC
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Ann Childress, M.D.
    Organizational Affiliation
    Center for Psychiatry And Behavioral Medicine Inc.
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Frank Lopez, M.D.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17631866
    Citation
    Biederman J, Boellner SW, Childress A, Lopez FA, Krishnan S, Zhang Y. Lisdexamfetamine dimesylate and mixed amphetamine salts extended-release in children with ADHD: a double-blind, placebo-controlled, crossover analog classroom study. Biol Psychiatry. 2007 Nov 1;62(9):970-6. doi: 10.1016/j.biopsych.2007.04.015. Epub 2007 Jul 12.
    Results Reference
    result
    PubMed Identifier
    20215923
    Citation
    Faraone SV, Spencer TJ, Kollins SH, Glatt SJ. Effects of lisdexamfetamine dimesylate treatment for ADHD on growth. J Am Acad Child Adolesc Psychiatry. 2010 Jan;49(1):24-32. doi: 10.1097/00004583-201001000-00006.
    Results Reference
    derived
    Links:
    URL
    http://www.vyvanse.com/pdf/prescribing_information.pdf
    Description
    FDA-approved label, US only
    URL
    http://www.fda.gov/opacom/7alerts.html
    Description
    FDA Recall information

    Learn more about this trial

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

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