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)
1 other identifier
interventional
314
1 country
45
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2008
Shorter than P25 for phase_3
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2008
CompletedFirst Posted
Study publicly available on registry
August 14, 2008
CompletedStudy Start
First participant enrolled
October 8, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 6, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 6, 2009
CompletedResults Posted
Study results publicly available
February 23, 2010
CompletedJune 14, 2021
June 1, 2021
6 months
August 12, 2008
February 1, 2010
June 8, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores
1, 2, 3 and 4 Weeks
Youth Quality of Life-Research Version (YQOL-R) Total Score
Baseline and 4 weeks
Study Arms (4)
Lisdexamfetamine Dimesylate (LDX) 30 mg
ACTIVE COMPARATORLDX 50 mg
ACTIVE COMPARATORLDX 70 mg
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (45)
Clinical Study Centers, LLC
Little Rock, Arkansas, 72205, United States
Valley Clinical Research, Inc.
El Centro, California, 92243, United States
Peninsula Research Associates, Inc
Rolling Hills Estates, California, 90274, United States
Psychiatric Centers at San Diego (PCSD-Feighner Research Institute)
San Diego, California, 92108, United States
Elite Clinical Trials, Inc
Wildomar, California, 92595, United States
Florida Clinical Research Center, LLC
Bradenton, Florida, 34208, United States
Sarkis Clinical Trials
Gainesville, Florida, 32607, United States
Amedica Research Institute, Inc.
Hialeah, Florida, 33013, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32216, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32806-1122, United States
Miami Research Associates
South Miami, Florida, 33143, United States
Janus Center for Psychiatric Research
West Palm Beach, Florida, 33407, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30308, United States
Northwest Behavioral Research Center
Marietta, Georgia, 30060, United States
Capstone Clinical Research
Libertyville, Illinois, 60048, United States
Clinco Inc.
Terre Haute, Indiana, 47802, United States
Cientifica, Inc at Prairie View
Newton, Kansas, 67114, United States
Psychiatric Associates
Overland Park, Kansas, 66211, United States
Vince and Associates Clinical Research, Inc.
Overland Park, Kansas, 66212, United States
Pedia Research, LLC
Owensboro, Kentucky, 42301, United States
Four Rivers Clinical Research, Inc.
Paducah, Kentucky, 42003, United States
Louisiana Research Associates, Inc
New Orleans, Louisiana, 70114, United States
Bart Sangal, MD
Troy, Michigan, 48085, United States
Center for Psychiatry and Behavioral Medicine, Inc
Las Vegas, Nevada, 89128, United States
Children's Specialized Hospital
Toms River, New Jersey, 08755, United States
Bioscience Research, LLC
Mount Kisco, New York, 10549, United States
Triangle Neuropsychiatry, PLLC
Durham, North Carolina, 27707, United States
Innovis Health/Odyssey Research
Fargo, North Dakota, 58104, United States
University Hospitals of Cleveland Division of Child Adolescent Psychiatry
Cleveland, Ohio, 44106, United States
IPS Research Company
Oklahoma City, Oklahoma, 73103, United States
OCCI
Eugene, Oregon, 97401, United States
Summit Research Network
Portland, Oregon, 97210, United States
OCCI Inc
Salem, Oregon, 97301, United States
CRI Worldwide
Philadelphia, Pennsylvania, 19139, United States
Youth and Family Research Program/WP IC ADHD Research Program
Pittsburgh, Pennsylvania, 15213, United States
Valerie Arnold
Memphis, Tennessee, 38119, United States
FutureSearch Trials
Austin, Texas, 78756, United States
Bayou City Research, Ltd
Houston, Texas, 77007, United States
Red Oak Psychiatry Associates, PA
Houston, Texas, 77090, United States
ADHD Clinic of San Antonio
San Antonio, Texas, 78247, United States
Vermont Clinical Study Center
Burlington, Vermont, 05401, United States
Neuropsychiatric Associates
Woodstock, Vermont, 05091, United States
Neuroscience, Inc
Herndon, Virginia, 20170, United States
Dominion Clinical Research
Midlothian, Virginia, 23112, United States
Northwest Clinical Research Center
Bellevue, Washington, 98004, United States
Related Publications (1)
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.
PMID: 21421179RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Shire
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2008
First Posted
August 14, 2008
Study Start
October 8, 2008
Primary Completion
April 6, 2009
Study Completion
April 6, 2009
Last Updated
June 14, 2021
Results First Posted
February 23, 2010
Record last verified: 2021-06