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

Primary Purpose

Attention Deficit Hyperactivity Disorder (ADHD)

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
LDX 30 mg
LDX 50 mg
LDX 70 mg
Placebo
Sponsored by
Shire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder (ADHD)

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinical Study Centers, LLC
  • Valley Clinical Research, Inc.
  • Peninsula Research Associates, Inc
  • Psychiatric Centers at San Diego (PCSD-Feighner Research Institute)
  • Elite Clinical Trials, Inc
  • Florida Clinical Research Center, LLC
  • Sarkis Clinical Trials
  • Amedica Research Institute, Inc.
  • Clinical Neuroscience Solutions, Inc.
  • Clinical Neuroscience Solutions, Inc.
  • Miami Research Associates
  • Janus Center for Psychiatric Research
  • Atlanta Center for Medical Research
  • Northwest Behavioral Research Center
  • Capstone Clinical Research
  • Clinco Inc.
  • Cientifica, Inc at Prairie View
  • Psychiatric Associates
  • Vince and Associates Clinical Research, Inc.
  • Pedia Research, LLC
  • Four Rivers Clinical Research, Inc.
  • Louisiana Research Associates, Inc
  • Bart Sangal, MD
  • Center for Psychiatry and Behavioral Medicine, Inc
  • Children's Specialized Hospital
  • Bioscience Research, LLC
  • Triangle Neuropsychiatry, PLLC
  • Innovis Health/Odyssey Research
  • University Hospitals of Cleveland Division of Child Adolescent Psychiatry
  • IPS Research Company
  • OCCI
  • Summit Research Network
  • OCCI Inc
  • CRI Worldwide
  • Youth and Family Research Program/WP IC ADHD Research Program
  • Valerie Arnold
  • FutureSearch Trials
  • Bayou City Research, Ltd
  • Red Oak Psychiatry Associates, PA
  • ADHD Clinic of San Antonio
  • Vermont Clinical Study Center
  • Neuropsychiatric Associates
  • Neuroscience, Inc
  • Dominion Clinical Research
  • Northwest Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Lisdexamfetamine Dimesylate (LDX) 30 mg

LDX 50 mg

LDX 70 mg

Placebo

Arm Description

Outcomes

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
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
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
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.

Full Information

First Posted
August 12, 2008
Last Updated
June 8, 2021
Sponsor
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT00735371
Brief Title
Efficacy and Safety of Lisdexamfetamine Dimesylate (LDX) in Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
October 8, 2008 (Actual)
Primary Completion Date
April 6, 2009 (Actual)
Study Completion Date
April 6, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder (ADHD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
314 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lisdexamfetamine Dimesylate (LDX) 30 mg
Arm Type
Active Comparator
Arm Title
LDX 50 mg
Arm Type
Active Comparator
Arm Title
LDX 70 mg
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
LDX 30 mg
Other Intervention Name(s)
Vyvanse
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
LDX 50 mg
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
LDX 70 mg
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be identical to test product.
Primary Outcome Measure Information:
Title
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 4 Weeks
Description
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.
Time Frame
Baseline and 1, 2, 3 and 4 weeks
Secondary Outcome Measure Information:
Title
Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores
Description
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.
Time Frame
1, 2, 3 and 4 Weeks
Title
Youth Quality of Life-Research Version (YQOL-R) Total Score
Description
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.
Time Frame
Baseline and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Study Centers, LLC
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Valley Clinical Research, Inc.
City
El Centro
State/Province
California
ZIP/Postal Code
92243
Country
United States
Facility Name
Peninsula Research Associates, Inc
City
Rolling Hills Estates
State/Province
California
ZIP/Postal Code
90274
Country
United States
Facility Name
Psychiatric Centers at San Diego (PCSD-Feighner Research Institute)
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Elite Clinical Trials, Inc
City
Wildomar
State/Province
California
ZIP/Postal Code
92595
Country
United States
Facility Name
Florida Clinical Research Center, LLC
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
Sarkis Clinical Trials
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Amedica Research Institute, Inc.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806-1122
Country
United States
Facility Name
Miami Research Associates
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Janus Center for Psychiatric Research
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Northwest Behavioral Research Center
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Capstone Clinical Research
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
Facility Name
Clinco Inc.
City
Terre Haute
State/Province
Indiana
ZIP/Postal Code
47802
Country
United States
Facility Name
Cientifica, Inc at Prairie View
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Psychiatric Associates
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Vince and Associates Clinical Research, Inc.
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Facility Name
Pedia Research, LLC
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42301
Country
United States
Facility Name
Four Rivers Clinical Research, Inc.
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
Louisiana Research Associates, Inc
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70114
Country
United States
Facility Name
Bart Sangal, MD
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
Center for Psychiatry and Behavioral Medicine, Inc
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Children's Specialized Hospital
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Bioscience Research, LLC
City
Mount Kisco
State/Province
New York
ZIP/Postal Code
10549
Country
United States
Facility Name
Triangle Neuropsychiatry, PLLC
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27707
Country
United States
Facility Name
Innovis Health/Odyssey Research
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
University Hospitals of Cleveland Division of Child Adolescent Psychiatry
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
IPS Research Company
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
OCCI
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Summit Research Network
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
OCCI Inc
City
Salem
State/Province
Oregon
ZIP/Postal Code
97301
Country
United States
Facility Name
CRI Worldwide
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
Youth and Family Research Program/WP IC ADHD Research Program
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Valerie Arnold
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
FutureSearch Trials
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Bayou City Research, Ltd
City
Houston
State/Province
Texas
ZIP/Postal Code
77007
Country
United States
Facility Name
Red Oak Psychiatry Associates, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
ADHD Clinic of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78247
Country
United States
Facility Name
Vermont Clinical Study Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Neuropsychiatric Associates
City
Woodstock
State/Province
Vermont
ZIP/Postal Code
05091
Country
United States
Facility Name
Neuroscience, Inc
City
Herndon
State/Province
Virginia
ZIP/Postal Code
20170
Country
United States
Facility Name
Dominion Clinical Research
City
Midlothian
State/Province
Virginia
ZIP/Postal Code
23112
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21421179
Citation
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.
Results Reference
result
Links:
URL
http://www.vyvanse.com/pdf/prescribing_information.pdf
Description
FDA-approved label
URL
http://www.fda.gov/opacom/7alerts.html
Description
FDA recall information

Learn more about this trial

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

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