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
  Purpose

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


Condition Intervention Phase
ADHD
Drug: LDX 30 mg
Drug: LDX 50 mg
Drug: LDX 70 mg
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 314
Study Start Date: October 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lisdexamfetamine Dimesylate (LDX) 30 mg 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
Active Comparator: LDX 50 mg 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.
Active Comparator: LDX 70 mg 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.
Placebo Comparator: Placebo Drug: Placebo
Placebo will be identical to test product.

  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00735371

  Show 45 Study Locations
Sponsors and Collaborators
Shire
Investigators
Principal Investigator: Robert Findling, MD Case Western Reserve University School of Medicine
  More Information

Additional Information:
Publications:
Findling RL, Childress AC, Cutler AJ, et al. Efficacy and Safety of Lisdexamfetamine Dimesylate in Adolescents with Attention-Deficit/Hyperactivity Disorder. J. Am. Acad. Child Adolesc. Psychiatry 50(4):395-405,2011.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Timothy Whitaker, MD/Clinical Research & Development -VP of Global Clinical Medicine, Shire Pharmaceutical Development
ClinicalTrials.gov Identifier: NCT00735371     History of Changes
Other Study ID Numbers: SPD489-305
Study First Received: August 12, 2008
Results First Received: February 1, 2010
Last Updated: June 21, 2011
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dextroamphetamine
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014