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Efficacy and Safety of Lisdexamfetamine Dimesylate (LDX) in Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)

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ClinicalTrials.gov Identifier: NCT00735371
Recruitment Status : Completed
First Posted : August 14, 2008
Results First Posted : February 23, 2010
Last Update Posted : March 20, 2017
Sponsor:
Information provided by:
Shire

Tracking Information
First Submitted Date  ICMJE August 12, 2008
First Posted Date  ICMJE August 14, 2008
Results First Submitted Date  ICMJE February 1, 2010
Results First Posted Date  ICMJE February 23, 2010
Last Update Posted Date March 20, 2017
Study Start Date  ICMJE October 2008
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2010)
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 4 Weeks [ Time Frame: Baseline and 1, 2, 3 and 4 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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 13, 2008)
ADHD-RS-IV [ Time Frame: The ADHD-RS-IV will be administered at every visit starting at baseline ]
Change History Complete list of historical versions of study NCT00735371 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2010)
  • Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores [ Time Frame: 1, 2, 3 and 4 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.
  • Youth Quality of Life-Research Version (YQOL-R) Total Score [ Time Frame: Baseline and 4 weeks ]
    The Youth Quality of Life-research version (YQOL-R) is a validated 56-item generic instrument for comparing quality of life of adolescents across condition groups that scores each question on a scale from 0 (never) to 4 (very often). The YQOL scores are transformed to a 0-100 scale for easy interpretability. Higher scores indicate better quality of life.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2008)
CGI-I, Safety, YQOL-R [ Time Frame: The CGI will be administered at every visit starting at Baseline. Safety will be administered at every visit starting Screening. The YQOL-R will be administered at Baseline and Day 28. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Lisdexamfetamine Dimesylate (LDX) in Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
Official Title  ICMJE A Phase III, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled, Forced-dose Titration, Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Adolescents Aged 13-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)
Brief Summary The study will evaluate the efficacy of LDX treatment group compared to placebo on the change from Baseline ADHD-RS-IV score at endpoint.
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 Attention Deficit Hyperactivity Disorder (ADHD)
Intervention  ICMJE
  • Drug: LDX 30 mg
    Eligible subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of LDX (30, 50, or 70mg/day) or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period. The test product is LDX, available in 30, 50, and 70mg capsules. All test products will appear identical to placebo to protect the study blind.
    Other Name: Vyvanse
  • Drug: LDX 50 mg
    Eligible subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of LDX (30, 50, or 70mg/day) or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period. The test product is LDX, available in 30, 50, and 70mg capsules. All test products will appear identical to placebo to protect the study blind.
  • Drug: LDX 70 mg
    Eligible subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of LDX (30, 50, or 70mg/day) or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period. The test product is LDX, available in 30, 50, and 70mg capsules. All test products will appear identical to placebo to protect the study blind.
  • Drug: Placebo
    Placebo will be identical to test product.
Study Arms  ICMJE
  • Active Comparator: Lisdexamfetamine Dimesylate (LDX) 30 mg
    Intervention: Drug: LDX 30 mg
  • Active Comparator: LDX 50 mg
    Intervention: Drug: LDX 50 mg
  • Active Comparator: LDX 70 mg
    Intervention: Drug: LDX 70 mg
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Findling RL, Childress AC, Cutler AJ, Gasior M, Hamdani M, Ferreira-Cornwell MC, Squires L. Efficacy and safety of lisdexamfetamine dimesylate in adolescents with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2011 Apr;50(4):395-405. doi: 10.1016/j.jaac.2011.01.007. Epub 2011 Mar 3.

*   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: April 3, 2009)
314
Original Estimated Enrollment  ICMJE
 (submitted: August 13, 2008)
300
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Meet DSM-IV-TR criteria for a primary diagnosis of ADHD
  • Baseline ADHD-RS-IV score >=28
  • BP w/in 95th percentile for age, gender, and height

Exclusion Criteria:

  • Subject has controlled or uncontrolled comorbid psychiatric diagnosis
  • Subject has conduct disorder
  • Suicidal
  • Under or overweight
  • Concurrent chronic or acute illness that might confound results.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00735371
Other Study ID Numbers  ICMJE SPD489-305
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Timothy Whitaker, MD/Clinical Research & Development -VP of Global Clinical Medicine, Shire Pharmaceutical Development
Study Sponsor  ICMJE Shire
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert Findling, MD Case Western Reserve University School of Medicine
PRS Account Shire
Verification Date February 2017

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