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

This study has been completed.
Sponsor:
Information provided by:
Shire
ClinicalTrials.gov Identifier:
NCT00735371
First received: August 12, 2008
Last updated: June 21, 2011
Last verified: June 2011

August 12, 2008
June 21, 2011
October 2008
April 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
ADHD-RS-IV [ Time Frame: The ADHD-RS-IV will be administered at every visit starting at baseline ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00735371 on ClinicalTrials.gov Archive Site
  • Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores [ Time Frame: 1, 2, 3 and 4 Weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
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. ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Efficacy and Safety of Lisdexamfetamine Dimesylate (LDX) in Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
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)

The study will evaluate the efficacy of LDX treatment group compared to placebo on the change from Baseline ADHD-RS-IV score at endpoint.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
ADHD
  • 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.
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
314
April 2009
April 2009   (final data collection date for primary outcome measure)

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.
Both
13 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00735371
SPD489-305
No
Timothy Whitaker, MD/Clinical Research & Development -VP of Global Clinical Medicine, Shire Pharmaceutical Development
Shire
Not Provided
Principal Investigator: Robert Findling, MD Case Western Reserve University School of Medicine
Shire
June 2011

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