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Randomized, Double-blind Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17

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: NCT00763971
Recruitment Status : Completed
First Posted : October 1, 2008
Results First Posted : March 22, 2012
Last Update Posted : June 12, 2014
Sponsor:
Information provided by (Responsible Party):
Shire

Tracking Information
First Submitted Date  ICMJE September 30, 2008
First Posted Date  ICMJE October 1, 2008
Results First Submitted Date  ICMJE February 27, 2012
Results First Posted Date  ICMJE March 22, 2012
Last Update Posted Date June 12, 2014
Study Start Date  ICMJE October 2008
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2012)
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 7 Weeks [ Time Frame: Baseline and up to 7 weeks ]
The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. A decrease in score indicates an improvement in ADHD symptomology.
Original Primary Outcome Measures  ICMJE
 (submitted: September 30, 2008)
ADHD Rating Scale [ Time Frame: Weekly for 7 weeks of treatment ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2012)
  • Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores [ Time Frame: Up to 7 weeks ]
    Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
  • Change From Baseline in Conner's Parent Rating Scale - Revised (CPRS-R) Total Score at up to 7 Weeks [ Time Frame: Baseline and up to 7 weeks ]
    The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.
  • Health Utilities Index-2 (HUI-2) Scores at up to 7 Weeks [ Time Frame: Baseline and up to 7 weeks ]
    HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status.
  • Change From Baseline in the Child Health and Illness Profile, Child Edition: Parent Report Form (CHIP-CE:PRF) Global T-score at up to 7 Weeks [ Time Frame: Baseline and up to 7 weeks ]
    The CHIP-CE:PRF evaluates health-related quality of life. It is composed of 5 domains (satisfaction, comfort, resilience, avoidance, and achievement) consisting of a total of 76 items. The global score is an average of the scores for the 5 domains. The majority of items assess frequency of events using a 5-point response format. There is no range for a total score. Raw scale scores are used to generate T-scores. Higher scores indicate better health.
  • Change From Baseline in Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at up to 7 Weeks [ Time Frame: Baseline and up to 7 weeks ]
    The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.
  • Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at up to 7 Weeks [ Time Frame: Baseline and up to 7 weeks ]
    The BPRS-C characterizes psychopathology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology.
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Up to 7 weeks ]
    C-SSRS is a 19-item semi-structured interview designed to capture suicide-related thoughts and behaviors.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2008)
CPRS-R CGI-I WFIRS-P CHIP-CE/PRF HUI-2 Safety [ Time Frame: Weekly for safety, CPRS-R, CGI-I. At week 4 and week 7 for HUI, Week 7 for CHIP-CE/PRF and WFIRS-P ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized, Double-blind Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17
Official Title  ICMJE A Phase III, Randomised, Double-Blind, Multicentre, Parallel-Group, Placebo- and Active-Controlled, Dose-Optimisation Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)
Brief Summary The main aim of this study is to see if giving LDX to children and adolescents aged 6-17 years with ADHD decreases symptoms of ADHD.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE ADHD
Intervention  ICMJE
  • Drug: Lisdexamfetamine Dimesylate (LDX)
    30, 50 or 70mg capsule once per day (Overencapsulated)
    Other Name: Vyvanse™
  • Drug: Methylphenidate Hydrochloride
    18, 36, or 54mg tablet one per day (Overencapsulated)
    Other Name: Concerta®, OROS MPH
  • Drug: Placebo
    Placebo capsule once per day (Overencapsulated)
Study Arms  ICMJE
  • Experimental: Lisdexamfetamine Dimesylate (LDX)
    Overencapsulated LDX 30, 50, or 70mg
    Intervention: Drug: Lisdexamfetamine Dimesylate (LDX)
  • Active Comparator: Methylphenidate Hydrochloride
    Overencapsulated Concerta 18, 36, or 54mg
    Intervention: Drug: Methylphenidate Hydrochloride
  • Placebo Comparator: Placebo
    Overencapsulated Placebo
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 4, 2011)
336
Original Estimated Enrollment  ICMJE
 (submitted: September 30, 2008)
333
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject is a male or female aged 6-17 years inclusive at the time of consent.
  2. Subject must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR) criteria for a primary diagnosis of ADHD based on a detailed psychiatric evaluation.
  3. Subject must have a Baseline ADHD-RS-IV total score ≥28.
  4. Subject has blood pressure measurements within the 95th percentile for age, gender, and height at Screening and Baseline.
  5. Subject is able to swallow a capsule.

Exclusion Criteria:

  1. Subject has failed to respond to more than one adequate course (dose and duration) of stimulant therapy. One course must have been a long-acting formulation.
  2. Subject has a conduct disorder. Oppositional Defiant Disorder is not exclusionary.
  3. Subject is currently considered a suicide risk, has previously made a suicide attempt or has a prior history of, or is currently, demonstrating active suicidal ideation.
  4. Subject has glaucoma.
  5. Subject weighs less than 22.7kg (50lbs).
  6. Subject is significantly overweight based on Centre for Disease Control and Prevention Body Mass Index (BMI)-for-age gender specific charts at Screening. Significantly overweight is defined as a BMI >97th percentile for this study.
  7. Subject has a documented allergy, hypersensitivity, or intolerance to amphetamine or methylphenidate.
  8. Subject has a documented allergy, hypersensitivity, or intolerance to any excipients in the test or reference products.
  9. Subject has a history of seizures (other than infantile febrile seizures), a tic disorder, or a current diagnosis and/or a known family history of Tourette's Disorder.
  10. Subject has a known history of symptomatic cardiovascular disease, advance arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.
  11. Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
  12. Subject is well controlled on their current ADHD medication with acceptable tolerability.
  13. Subject has a pre-existing severe gastrointestinal tract narrowing (pathologic or iatrogenic).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France,   Germany,   Hungary,   Italy,   Netherlands,   Poland,   Spain,   Sweden,   United Kingdom
Removed Location Countries Romania,   Turkey
 
Administrative Information
NCT Number  ICMJE NCT00763971
Other Study ID Numbers  ICMJE SPD489-325
2008-000679-90 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shire
Study Sponsor  ICMJE Shire
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shire
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP