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

Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00735371
• Other study ID #: SPD489-305
• Status: Completed
• Phase: Phase 3
• Start date: October 8, 2008
• Est. completion date: April 6, 2009

Study information

• Verified date: June 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 314
• Est. completion date: April 6, 2009
• Est. primary completion date: April 6, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder (ADHD)
• Hyperkinesis

Intervention

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.
• 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.
• 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
Placebo will be identical to test product.

Locations

Country	Name	City	State
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	FutureSearch Trials	Austin	Texas
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Florida Clinical Research Center, LLC	Bradenton	Florida
United States	Vermont Clinical Study Center	Burlington	Vermont
United States	University Hospitals of Cleveland Division of Child Adolescent Psychiatry	Cleveland	Ohio
United States	Triangle Neuropsychiatry, PLLC	Durham	North Carolina
United States	Valley Clinical Research, Inc.	El Centro	California
United States	OCCI	Eugene	Oregon
United States	Innovis Health/Odyssey Research	Fargo	North Dakota
United States	Sarkis Clinical Trials	Gainesville	Florida
United States	Neuroscience, Inc	Herndon	Virginia
United States	Amedica Research Institute, Inc.	Hialeah	Florida
United States	Bayou City Research, Ltd	Houston	Texas
United States	Red Oak Psychiatry Associates, PA	Houston	Texas
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	Center for Psychiatry and Behavioral Medicine, Inc	Las Vegas	Nevada
United States	Capstone Clinical Research	Libertyville	Illinois
United States	Clinical Study Centers, LLC	Little Rock	Arkansas
United States	Northwest Behavioral Research Center	Marietta	Georgia
United States	Valerie Arnold	Memphis	Tennessee
United States	Dominion Clinical Research	Midlothian	Virginia
United States	Bioscience Research, LLC	Mount Kisco	New York
United States	Louisiana Research Associates, Inc	New Orleans	Louisiana
United States	Cientifica, Inc at Prairie View	Newton	Kansas
United States	IPS Research Company	Oklahoma City	Oklahoma
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	Psychiatric Associates	Overland Park	Kansas
United States	Vince and Associates Clinical Research, Inc.	Overland Park	Kansas
United States	Pedia Research, LLC	Owensboro	Kentucky
United States	Four Rivers Clinical Research, Inc.	Paducah	Kentucky
United States	CRI Worldwide	Philadelphia	Pennsylvania
United States	Youth and Family Research Program/WP IC ADHD Research Program	Pittsburgh	Pennsylvania
United States	Summit Research Network	Portland	Oregon
United States	Peninsula Research Associates, Inc	Rolling Hills Estates	California
United States	OCCI Inc	Salem	Oregon
United States	ADHD Clinic of San Antonio	San Antonio	Texas
United States	Psychiatric Centers at San Diego (PCSD-Feighner Research Institute)	San Diego	California
United States	Miami Research Associates	South Miami	Florida
United States	Clinco Inc.	Terre Haute	Indiana
United States	Children's Specialized Hospital	Toms River	New Jersey
United States	Bart Sangal, MD	Troy	Michigan
United States	Janus Center for Psychiatric Research	West Palm Beach	Florida
United States	Elite Clinical Trials, Inc	Wildomar	California
United States	Neuropsychiatric Associates	Woodstock	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

United States, 

References & 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) — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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

External Links

•   FDA recall information
•   FDA-approved label