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Phase 3 Randomized Double-Blind Placebo-Controlled Study of NRP104 in Children Aged 6-12 With ADHD

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
NRP104
NRP104
NRp104
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 Hyperactivity Disorder

Eligibility Criteria

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

Inclusion Criteria:

  • primary diagnosis of ADHD combined subtype or the predominantly hyperactive-impulsive subtype based on a psychiatric evaluation that reviews DSM-IV criteria
  • functioning at age appropriate levels intellectually
  • blood pressure measurements within the 95th percentile for their gender, height and age
  • ECG results are within the normal range

Exclusion Criteria:

  • comorbid psychiatric diagnosis (such as psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder) or other symptomatic manifestations
  • history of seizures (exclusive of febrile seizure), a tic disorder, or a family history of Tourette's disorder
  • weighs less than 55 lbs (25 kg)or is significantly overweight or obese
  • clinically significant ECG abnormality
  • documented allergy or intolerance to amphetamines

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    3

    4

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change score from baseline of the ADHD-RS

    Secondary Outcome Measures

    Duration of therapeutic responses using the CPRS ADHD Index
    Clinical global impression of severity(CGI-S) and improvement (CGI-I)
    Treatment emergent AEs

    Full Information

    First Posted
    November 7, 2007
    Last Updated
    June 20, 2011
    Sponsor
    New River Pharmaceuticals
    Collaborators
    Shire
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00556296
    Brief Title
    Phase 3 Randomized Double-Blind Placebo-Controlled Study of NRP104 in Children Aged 6-12 With ADHD
    Official Title
    A Phase 3, Randomized, Multi-Center, Double-Blind, Parallel-Group, Placebo-Controlled Study of NRP104 in Children Aged 6-12 Years With Attention Deficit Hyperactivity Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    September 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    New River Pharmaceuticals
    Collaborators
    Shire

    4. Oversight

    5. Study Description

    Brief Summary
    This study is designed to assess efficacy and safety of NRP-104 administered as a daily dose of 30mg, 50mg or 70mg compared to placebo in the treatment of children aged 6-12 years with ADHD.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    297 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Title
    2
    Arm Type
    Experimental
    Arm Title
    3
    Arm Type
    Experimental
    Arm Title
    4
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    NRP104
    Intervention Description
    NRP104 30mg capsule once daily in a.m.
    Intervention Type
    Drug
    Intervention Name(s)
    NRP104
    Intervention Description
    NRP104 50mg capsule once daily in a.m.
    Intervention Type
    Drug
    Intervention Name(s)
    NRp104
    Intervention Description
    NRP104 70mg capsule once daily in a.m.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo
    Primary Outcome Measure Information:
    Title
    Change score from baseline of the ADHD-RS
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Duration of therapeutic responses using the CPRS ADHD Index
    Time Frame
    At treatment endpoint, separately for morning, afternoon and evening responses
    Title
    Clinical global impression of severity(CGI-S) and improvement (CGI-I)
    Time Frame
    Treatment endpoint
    Title
    Treatment emergent AEs
    Time Frame
    4 weeks

    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: primary diagnosis of ADHD combined subtype or the predominantly hyperactive-impulsive subtype based on a psychiatric evaluation that reviews DSM-IV criteria functioning at age appropriate levels intellectually blood pressure measurements within the 95th percentile for their gender, height and age ECG results are within the normal range Exclusion Criteria: comorbid psychiatric diagnosis (such as psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder) or other symptomatic manifestations history of seizures (exclusive of febrile seizure), a tic disorder, or a family history of Tourette's disorder weighs less than 55 lbs (25 kg)or is significantly overweight or obese clinically significant ECG abnormality documented allergy or intolerance to amphetamines
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Suma Krishnan
    Organizational Affiliation
    New River Pharmaceuticals
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17577466
    Citation
    Biederman J, Krishnan S, Zhang Y, McGough JJ, Findling RL. Efficacy and tolerability of lisdexamfetamine dimesylate (NRP-104) in children with attention-deficit/hyperactivity disorder: a phase III, multicenter, randomized, double-blind, forced-dose, parallel-group study. Clin Ther. 2007 Mar;29(3):450-63. doi: 10.1016/s0149-2918(07)80083-x.
    Results Reference
    result
    Citation
    Faraone SV, Spencer TJ, Kollins SH and Glatt SJ. Moderators of Dose-Response Effects of Lisdexamfetamine Dimesylate Treatment in Children With ADHD. Journal of ADHD and Related Disorders 1(3):16-24, 2010
    Results Reference
    result
    PubMed Identifier
    22054243
    Citation
    Jain R, Babcock T, Burtea T, Dirks B, Adeyi B, Scheckner B, Lasser R. Efficacy of lisdexamfetamine dimesylate in children with attention-deficit/hyperactivity disorder previously treated with methylphenidate: a post hoc analysis. Child Adolesc Psychiatry Ment Health. 2011 Nov 4;5(1):35. doi: 10.1186/1753-2000-5-35.
    Results Reference
    derived
    PubMed Identifier
    21367347
    Citation
    Waxmonsky JG, Waschbusch DA, Glatt SJ, Faraone SV. Prediction of placebo response in 2 clinical trials of lisdexamfetamine dimesylate for the treatment of ADHD. J Clin Psychiatry. 2011 Oct;72(10):1366-75. doi: 10.4088/JCP.10m05979pur.
    Results Reference
    derived
    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

    Phase 3 Randomized Double-Blind Placebo-Controlled Study of NRP104 in Children Aged 6-12 With ADHD

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