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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
• Intervention / Treatment: Drug: LDX 30 mg; Drug: LDX 50 mg; Drug: LDX 70 mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 314
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Clinical Study Centers, LLC
  • California
    • El Centro, California, United States, 92243
      • Valley Clinical Research, Inc.
    • Rolling Hills Estates, California, United States, 90274
      • Peninsula Research Associates, Inc
    • San Diego, California, United States, 92108
      • Psychiatric Centers at San Diego (PCSD-Feighner Research Institute)
    • Wildomar, California, United States, 92595
      • Elite Clinical Trials, Inc
  • Florida
    • Bradenton, Florida, United States, 34208
      • Florida Clinical Research Center, LLC
    • Gainesville, Florida, United States, 32607
      • Sarkis Clinical Trials
    • Hialeah, Florida, United States, 33013
      • Amedica Research Institute, Inc.
    • Jacksonville, Florida, United States, 32216
      • Clinical Neuroscience Solutions, Inc.
    • Orlando, Florida, United States, 32806-1122
      • Clinical Neuroscience Solutions, Inc.
    • South Miami, Florida, United States, 33143
      • Miami Research Associates
    • West Palm Beach, Florida, United States, 33407
      • Janus Center For Psychiatric Research
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Atlanta Center for Medical Research
    • Marietta, Georgia, United States, 30060
      • Northwest Behavioral Research Center
  • Illinois
    • Libertyville, Illinois, United States, 60048
      • Capstone Clinical Research
  • Indiana
    • Terre Haute, Indiana, United States, 47802
      • Clinco Inc.
  • Kansas
    • Newton, Kansas, United States, 67114
      • Cientifica, Inc at Prairie View
    • Overland Park, Kansas, United States, 66211
      • Psychiatric Associates
    • Overland Park, Kansas, United States, 66212
      • Vince and Associates Clinical Research, Inc.
  • Kentucky
    • Owensboro, Kentucky, United States, 42301
      • Pedia Research, LLC
    • Paducah, Kentucky, United States, 42003
      • Four Rivers Clinical Research, Inc.
  • Louisiana
    • New Orleans, Louisiana, United States, 70114
      • Louisiana Research Associates, Inc
  • Michigan
    • Troy, Michigan, United States, 48085
      • Bart Sangal, MD
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Center For Psychiatry And Behavioral Medicine, Inc
  • New Jersey
    • Toms River, New Jersey, United States, 08755
      • Children's Specialized Hospital
  • New York
    • Mount Kisco, New York, United States, 10549
      • Bioscience Research, LLC
  • North Carolina
    • Durham, North Carolina, United States, 27707
      • Triangle Neuropsychiatry, PLLC
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Innovis Health/Odyssey Research
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals of Cleveland Division of Child Adolescent Psychiatry
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • IPS Research Company
  • Oregon
    • Eugene, Oregon, United States, 97401
      • OCCI
    • Portland, Oregon, United States, 97210
      • Summit Research Network
    • Salem, Oregon, United States, 97301
      • OCCI Inc
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19139
      • CRI Worldwide
    • Pittsburgh, Pennsylvania, United States, 15213
      • Youth and Family Research Program/WP IC ADHD Research Program
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Valerie Arnold
  • Texas
    • Austin, Texas, United States, 78756
      • FutureSearch Trials
    • Houston, Texas, United States, 77007
      • Bayou City Research, Ltd
    • Houston, Texas, United States, 77090
      • Red Oak Psychiatry Associates, PA
    • San Antonio, Texas, United States, 78247
      • ADHD Clinic of San Antonio
  • Vermont
    • Burlington, Vermont, United States, 05401
      • Vermont Clinical Study Center
    • Woodstock, Vermont, United States, 05091
      • Neuropsychiatric Associates
  • Virginia
    • Herndon, Virginia, United States, 20170
      • Neuroscience, Inc
    • Midlothian, Virginia, United States, 23112
      • Dominion Clinical Research
  • Washington
    • Bellevue, Washington, United States, 98004
      • Northwest Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo will be identical to test product.
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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 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.	Baseline and 1, 2, 3 and 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores	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.	1, 2, 3 and 4 Weeks
Youth Quality of Life-Research Version (YQOL-R) Total Score	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.	Baseline and 4 weeks

Collaborators and Investigators

• Sponsor: Shire

Publications and helpful links

General 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.

Helpful Links

• FDA Recall Information
• FDA-approved Label

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2008
• Primary Completion (Actual): April 6, 2009
• Study Completion (Actual): April 6, 2009

Study Registration Dates

• First Submitted: August 12, 2008
• First Submitted That Met QC Criteria: August 13, 2008
• First Posted (Estimate): August 14, 2008

Study Record Updates

• Last Update Posted (Actual): June 14, 2021
• Last Update Submitted That Met QC Criteria: June 8, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Lisdexamfetamine Dimesylate
• Other Study ID Numbers: SPD489-305

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No