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The Safety and Efficacy of SPD465 in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

Primary Purpose

Attention-Deficit/Hyperactivity Disorder

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SPD465
Immediate Release Amphetamine Salt
Placebo
Sponsored by
Shire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention-Deficit/Hyperactivity Disorder

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult men and non-pregnant women between the ages of 18 and 55
  • Confirmed diagnosis of ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
  • Baseline ADHD score of at least 24

Exclusion Criteria:

  • Weight less than 100 pounds or greater than 250 pounds
  • Psychiatric diagnosis such as a severe comorbid Axis II or Axis I disorder
  • Pregnancy or breastfeeding
  • History of seizures
  • Positive urine drug screen

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Placebo Comparator

    Arm Label

    SPD465 (50 or 75 mg)

    Immediate Release Amphetamine salt (25 mg)

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    To assess the duration of efficacy of SPD465 compared to placebo and immediate release amphetamine formulation in adults with ADHD using the Permanent Product Measure of Performance (PERMP) math test

    Secondary Outcome Measures

    To assess the duration of efficacy of SPD465 compared with placebo and immediate release amphetamine on ADHD symptoms as determined by the ADHD-rating scale (ADHD-RS)
    To assess the duration of efficacy of SPD465 compared with placebo and immediate release amphetamine on ADHD symptoms as determined by the Swanson, Kotkin, Agler, M. Flynn, and Pelham (SKAMP) scale
    To assess the impact of SPD465 compared with placebo and immediate release amphetamine on sleep as measured by the modified Pittsburgh Sleep Quality Index (PSQI)
    To evaluate the safety of SPD465 based on occurrence of treatment-emergent adverse events (TEAEs), blood pressure (BP), heart rate, electrocardiogram (ECG), and clinical laboratory findings

    Full Information

    First Posted
    June 23, 2009
    Last Updated
    June 1, 2021
    Sponsor
    Shire
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00928148
    Brief Title
    The Safety and Efficacy of SPD465 in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
    Official Title
    A Phase 2, Randomized, Double-Blind, Multi-Center, Placebo- and Active-Controlled, Crossover Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    June 14, 2004 (Actual)
    Primary Completion Date
    November 20, 2004 (Actual)
    Study Completion Date
    November 20, 2004 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shire

    4. Oversight

    5. Study Description

    Brief Summary
    This is a phase 2, randomized, multi-center, double-blind, 3-period and 3-treatment crossover study designed to evaluate the safety and duration of efficacy of SPD465 (50 or 75 mg) compared with placebo and an immediate release amphetamine salt formulation (25 mg) in adults with ADHD. The controlled environment used in this study is an analog classroom setting adapted for a 16-hour adult day.

    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 2
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    86 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    SPD465 (50 or 75 mg)
    Arm Type
    Experimental
    Arm Title
    Immediate Release Amphetamine salt (25 mg)
    Arm Type
    Active Comparator
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    SPD465
    Intervention Description
    50 or 75 mg once daily for 7 days
    Intervention Type
    Drug
    Intervention Name(s)
    Immediate Release Amphetamine Salt
    Intervention Description
    25 mg once daily for 7 days
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Once daily for 7 days
    Primary Outcome Measure Information:
    Title
    To assess the duration of efficacy of SPD465 compared to placebo and immediate release amphetamine formulation in adults with ADHD using the Permanent Product Measure of Performance (PERMP) math test
    Time Frame
    -0.5, 2, 4, 8, 12, 14 and 18 hours post-dose
    Secondary Outcome Measure Information:
    Title
    To assess the duration of efficacy of SPD465 compared with placebo and immediate release amphetamine on ADHD symptoms as determined by the ADHD-rating scale (ADHD-RS)
    Time Frame
    5, 10 and 15 hours post-dose
    Title
    To assess the duration of efficacy of SPD465 compared with placebo and immediate release amphetamine on ADHD symptoms as determined by the Swanson, Kotkin, Agler, M. Flynn, and Pelham (SKAMP) scale
    Time Frame
    5, 10, and 15 hours post-dose
    Title
    To assess the impact of SPD465 compared with placebo and immediate release amphetamine on sleep as measured by the modified Pittsburgh Sleep Quality Index (PSQI)
    Time Frame
    21 days
    Title
    To evaluate the safety of SPD465 based on occurrence of treatment-emergent adverse events (TEAEs), blood pressure (BP), heart rate, electrocardiogram (ECG), and clinical laboratory findings
    Time Frame
    21 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult men and non-pregnant women between the ages of 18 and 55 Confirmed diagnosis of ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) Baseline ADHD score of at least 24 Exclusion Criteria: Weight less than 100 pounds or greater than 250 pounds Psychiatric diagnosis such as a severe comorbid Axis II or Axis I disorder Pregnancy or breastfeeding History of seizures Positive urine drug screen
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Study Director
    Organizational Affiliation
    Takeda
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29809075
    Citation
    Wigal T, Brams M, Frick G, Yan B, Madhoo M. A randomized, double-blind study of SHP465 mixed amphetamine salts extended-release in adults with ADHD using a simulated adult workplace design. Postgrad Med. 2018 Jun;130(5):481-493. doi: 10.1080/00325481.2018.1481712. Epub 2018 Jun 18.
    Results Reference
    derived

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    The Safety and Efficacy of SPD465 in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

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