Lisdexamfetamine Dimesylate (LDX) Pilot Cognition Study to Evaluate the Utility of a Standardized Battery of Tests in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)

Verified by: Shire Pharmaceutical Development, February 2011
First Received: November 9, 2009 | Last Updated: February 24, 2011 | Phase: Phase 1 | Start Date: January 2010
Overall Status: Completed | Estimated Enrollment: 18
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To evaluate the sensitivity and responsiveness of a standardized, validated, computer-based, battery of neuro-psychometric tests in adults with ADHD...

Brief Summary

Official Title: “A Phase I, Randomized, Double Blind, Three-Period Crossover, Estimation Study Using Lisdexamfetamine Dimesylate, Immediate Release Mixed Amphetamine Salts and Placebo to Evaluate the Utility of a Standardized Computer Battery of Tests in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)”

To evaluate the sensitivity and responsiveness of a standardized, validated, computer-based, battery of neuro-psychometric tests in adults with ADHD.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 2010

Intervention(s) in this Clinical Trial

  • Drug: Lisdexamfetamine Dimesylate (LDX)
    • Lisdexamfetamine Dimesylate (LDX) + Immediate Release Mixed Amphetamine Salts (MAS-IR) placebo
  • Drug: Immediate Release Mixed Amphetamine Salts (MAS-IR)
    • Immediate Release Mixed Amphetamine Salts (MAS-IR) + Lisdexamfetamine Dimesylate (LDX) placebo
  • Drug: LDX Placebo + MAS-IR Placebo
    • Lisdexamfetamine Dimesylate (LDX) Placebo + Immediate Release Mixed Amphetamine Salts (MAS-IR) Placebo

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: LDX + MAS-IR Placebo
    • Lisdexamfetamine Dimesylate (LDX) + Immediate Release Mixed Amphetamine Salts (MAS-IR) placebo
  • Active Comparator: MAS-IR + LDX Placebo
    • Immediate Release Mixed Amphetamine Salts (MAS-IR) + Lisdexamfetamine Dimesylate (LDX) placebo
  • Placebo Comparator: Placebo
    • Lisdexamfetamine Dimesylate (LDX) Placebo + Immediate Release Mixed Amphetamine Salts (MAS-IR) Placebo

Outcome Measures for this Clinical Trial

Primary Measures

  • Power of Attention Score
    • Time Frame: pre-dose and at 1, 2, 3, 4, 5, 8, 12, 14 and 16 hours post-dose on Day 7
      Safety Issue?: No

Secondary Measures

  • Conners Adult ADHD Rating Scales-Self Report: Short Version (CAARS-S:S) Subscale Total Score (T-Score): Inattention/Memory Problems
    • Time Frame: 2 and 14 hours post-dose on Day 7
      Safety Issue?: No
  • CAARS-S:S Subscale T-Score: Hyperactivity/Restlessness
    • Time Frame: 2 and 14 hours post-dose on Day 7
      Safety Issue?: No
  • CAARS-S:S Subscale T-Score: Impulsivity/Emotional Liability
    • Time Frame: 2 and 14 hours post-dose on Day 7
      Safety Issue?: No
  • CAARS-S:S Subscale T-Score: Problems With Self-Concept
    • Time Frame: 2 and 14 hours post-dose on Day 7
      Safety Issue?: No
  • CAARS-S:S Subscale T-Score: Attention Deficit Hyperactivity Disorder (ADHD) Index
    • Time Frame: 2 and 14 hours post-dose on Day 7
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • 1. Subject meets Diagnostic and Statistical Manual of Mental Disorders Fourth Edition;
  • Text Revision (DSM IV TR) criteria for a primary diagnosis of ADHD (diagnostic code 314.00 and 314.01) established by a comprehensive psychiatric evaluation that reviews
  • DSM-IV-TR criteria with at least 6 of the 9 subtype criteria met.
  • 2. Subject has been previously treated for ADHD with an adequate course of amphetamine therapy with no history of intolerance, or lack of efficacy, as determined by the Investigator.
  • 3. Subject does not have any physical disability (eg. colorblindness, limitations with use of one or both hands, etc) that would interfere with the subject's participation in or performance on any of the neuropsychometric tests. For a number of these tasks speed is a key factor thus subjects cannot have any obvious impediments/impairments in the use of their hands.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Shire Pharmaceutical Development Industry

Overall Clinical Trial Officials and Contacts

Gerald Tremblay Study Director Shire Pharmaceutical Development  

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01010750

Study ID Number: SPD489-115

ClinicalTrials.gov Identifier: NCT01010750

Health Authority: United States: Food and Drug Administration

FDA recall information

FDA Medical Product Safety Alerts

FDA-approved label

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