Back to resultsDose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (Lisdexamfetamine Dimesylate) in Children Aged 6-12 Diagnosed With ADHD
Primary Purpose
Attention Deficit Hyperactivity Disorder (ADHD)
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Vyvanse (lisdexamfetamine dimesylate)
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder (ADHD)
Eligibility Criteria
Inclusion Criteria
- Subject is a male or female aged 6-12 years inclusive at the time of consent.
- Females of Child-bearing Potential (FOCP) must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test at Screening and a negative urine pregnancy test at Baseline and agree to comply with any applicable contraceptive requirements of the protocol.
- primary diagnosis of ADHD based on a detailed psychiatric evaluation.
- Subjects must have a baseline ADHD-RS-IV total score ≥28.
- Subject is functioning at an age-appropriate level intellectually.
- comply with all the testing and requirements.
- Subject is able to swallow a capsule.
- Subject has blood pressure measurements within the 95th percentile for age, gender, and height.
Exclusion Criteria
- Subject has a current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as Post Traumatic Stress Disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder or other symptomatic manifestations.
- Subject has Conduct Disorder.
- Subject has a documented allergy, hypersensitivity, or intolerance to amphetamines.
- Subject has failed to respond to one or more adequate courses (dose and duration) of amphetamine therapy.
- The subject has a recent history (within the past 6 months) of suspected substance abuse or dependence.
- Subject has a positive urine drug result.
- Subject weighs less than 50 pounds (22.7kg).
- Subject is significantly overweight.
- Subject has a history of seizures (exclusive of febrile seizures), a tic disorder, a current diagnosis and/or family history of Tourette's Disorder.
- Subject has any reported history of abnormal thyroid function.
- Subject has taken another investigational product or taken part in a clinical trial within 30 days prior to Screening.
- Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or an infectious process requiring antibiotics), disability, or other condition that might confound the results of safety assessments.
- The female subject is pregnant or lactating.
- Subject is well-controlled on their current ADHD medication with acceptable tolerability.
Sites / Locations
- Melmed Center
- Valley Clinical Research
- Peninsula Research Assoc, Inc
- UCSF-Langely Porter Psych Institute
- Encompass Clinical Research
- Shire Clinical Research Site
- Sarkis Clinical Trials
- Shire Clinical Research Site
- CNS Research Institute, Inc
- CORE Research, Inc
- Miami Research Associates
- Clinical Neuroscience Solutions, Inc
- Janus Center for Psychiatric Research
- Children's Development Center
- Capstone Clinical Research
- Indiana University School of Medicine
- Shire Clinical Research Site
- Shire Clinical Research Site
- Psychiatric Associates
- Kentucky Pediatric/Adult Research
- Shire Clinical Research Site
- Pedia Research
- Four Rivers Clinical Research, Inc.
- Shire Clinical Research Site
- University of Rochester, School of Medicine and Dentistry
- Piedmont Neuropsychiatry
- University Commons Office Park
- University Hospitals of Cleveland
- BHI, Inc.
- Shire Clinical Research Site
- Oregon Center for Clinical Investigations, Inc
- Oregon Center For Clinical Investigations, Inc.
- Summit Research Network
- Oregon Center for Clinical Investigations, Inc.
- ADHD Program, Western Psychiatric Institute and Clinic
- The Jackson Clinic
- Clinical Neuroscience Solutions, Inc
- FutureSearch Trials
- Claghorn-Lesem Research Clinic Inc.
- Red Oak Psychiatry Associates P.A.
- R/D Clinical Research, Inc.
- ADHD Clinic of San Antonio
- NeuroScience, Inc
- Dominion Clinical Research
- International Clinical Research Associates, LLC
- Eastside Therapeutic Resource
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Change From Baseline in Total Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Score at 7 Weeks
Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. 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
Weekly Change From Baseline in Total ADHD-RS-IV Score
Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. 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.
Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I)
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 or 2 on the scale.
Number of Participants With Improvement onParent Global Assessment (PGA)
Parent Global Assessment (PGA) 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.
Change From Baseline in Expression and Emotional Scale for Children (EESC) Scores at 7 Weeks
Expression and Emotional Scale for Children (EESC) consists of 29 items rated on a scale from 1 (not true at all) to 5 (very much true). Lower scores reflect better emotional outcomes.
Changes From Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Scores at 7 Weeks
Behavior Rating Inventory of Executive Function (BRIEF) is an 86-item questionnaire composed of three scales (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). Lower scores reflect better functioning.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00500071
Brief Title
Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (Lisdexamfetamine Dimesylate) in Children Aged 6-12 Diagnosed With ADHD
Official Title
A Prospective, Open-Label, Multi-Center, Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (Lisdexamfetamine Dimesylate) 20-70mg in Children Aged 6-12 Diagnosed With ADHD
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 28, 2007 (Actual)
Primary Completion Date
January 2, 2008 (Actual)
Study Completion Date
January 2, 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire
4. Oversight
5. Study Description
Brief Summary
Assess the efficacy & tolerability of Vyvanse when children aged 6-12 years diagnosed with ADHD are dosed to optimal effect.
Detailed Description
Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (lisdexamfetamine dimesylate) in Children aged 6-12 Diagnosed with ADHD
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 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
318 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Vyvanse (lisdexamfetamine dimesylate)
Intervention Description
Vyvanse™ 20mg once daily at 7 a.m.; dose increased weekly by 10mg until an acceptable response is achieved. Titration may proceed to a maximum daily dose 70mg/day.
Primary Outcome Measure Information:
Title
Change From Baseline in Total Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Score at 7 Weeks
Description
Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. 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 7 weeks
Secondary Outcome Measure Information:
Title
Weekly Change From Baseline in Total ADHD-RS-IV Score
Description
Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. 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, 4, 5, 6, and 7 weeks
Title
Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I)
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 or 2 on the scale.
Time Frame
7 weeks
Title
Number of Participants With Improvement onParent Global Assessment (PGA)
Description
Parent Global Assessment (PGA) 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
7 weeks
Title
Change From Baseline in Expression and Emotional Scale for Children (EESC) Scores at 7 Weeks
Description
Expression and Emotional Scale for Children (EESC) consists of 29 items rated on a scale from 1 (not true at all) to 5 (very much true). Lower scores reflect better emotional outcomes.
Time Frame
Baseline and 7 weeks
Title
Changes From Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Scores at 7 Weeks
Description
Behavior Rating Inventory of Executive Function (BRIEF) is an 86-item questionnaire composed of three scales (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). Lower scores reflect better functioning.
Time Frame
Baseline and 7 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Subject is a male or female aged 6-12 years inclusive at the time of consent.
Females of Child-bearing Potential (FOCP) must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test at Screening and a negative urine pregnancy test at Baseline and agree to comply with any applicable contraceptive requirements of the protocol.
primary diagnosis of ADHD based on a detailed psychiatric evaluation.
Subjects must have a baseline ADHD-RS-IV total score ≥28.
Subject is functioning at an age-appropriate level intellectually.
comply with all the testing and requirements.
Subject is able to swallow a capsule.
Subject has blood pressure measurements within the 95th percentile for age, gender, and height.
Exclusion Criteria
Subject has a current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as Post Traumatic Stress Disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder or other symptomatic manifestations.
Subject has Conduct Disorder.
Subject has a documented allergy, hypersensitivity, or intolerance to amphetamines.
Subject has failed to respond to one or more adequate courses (dose and duration) of amphetamine therapy.
The subject has a recent history (within the past 6 months) of suspected substance abuse or dependence.
Subject has a positive urine drug result.
Subject weighs less than 50 pounds (22.7kg).
Subject is significantly overweight.
Subject has a history of seizures (exclusive of febrile seizures), a tic disorder, a current diagnosis and/or family history of Tourette's Disorder.
Subject has any reported history of abnormal thyroid function.
Subject has taken another investigational product or taken part in a clinical trial within 30 days prior to Screening.
Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or an infectious process requiring antibiotics), disability, or other condition that might confound the results of safety assessments.
The female subject is pregnant or lactating.
Subject is well-controlled on their current ADHD medication with acceptable tolerability.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Melmed Center
City
Scottsdale
State/Province
Arizona
Country
United States
Facility Name
Valley Clinical Research
City
El Centro
State/Province
California
Country
United States
Facility Name
Peninsula Research Assoc, Inc
City
Rolling Hills Estates
State/Province
California
Country
United States
Facility Name
UCSF-Langely Porter Psych Institute
City
San Francisco
State/Province
California
Country
United States
Facility Name
Encompass Clinical Research
City
Spring Valley
State/Province
California
Country
United States
Facility Name
Shire Clinical Research Site
City
Wildomar
State/Province
California
Country
United States
Facility Name
Sarkis Clinical Trials
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
Shire Clinical Research Site
City
Hialeah
State/Province
Florida
Country
United States
Facility Name
CNS Research Institute, Inc
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
CORE Research, Inc
City
Maitland
State/Province
Florida
Country
United States
Facility Name
Miami Research Associates
City
Miami
State/Province
Florida
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Janus Center for Psychiatric Research
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
Children's Development Center
City
Winter Park
State/Province
Florida
Country
United States
Facility Name
Capstone Clinical Research
City
Libertyville
State/Province
Illinois
Country
United States
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Shire Clinical Research Site
City
Terre Haute
State/Province
Indiana
Country
United States
Facility Name
Shire Clinical Research Site
City
Newton
State/Province
Kansas
Country
United States
Facility Name
Psychiatric Associates
City
Overland Park
State/Province
Kansas
Country
United States
Facility Name
Kentucky Pediatric/Adult Research
City
Bardstown
State/Province
Kentucky
Country
United States
Facility Name
Shire Clinical Research Site
City
Lexington
State/Province
Kentucky
Country
United States
Facility Name
Pedia Research
City
Owensboro
State/Province
Kentucky
Country
United States
Facility Name
Four Rivers Clinical Research, Inc.
City
Paducah
State/Province
Kentucky
Country
United States
Facility Name
Shire Clinical Research Site
City
Troy
State/Province
Michigan
Country
United States
Facility Name
University of Rochester, School of Medicine and Dentistry
City
Rochester
State/Province
New York
Country
United States
Facility Name
Piedmont Neuropsychiatry
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
University Commons Office Park
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
BHI, Inc.
City
Moore
State/Province
Oklahoma
Country
United States
Facility Name
Shire Clinical Research Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Oregon Center for Clinical Investigations, Inc
City
Eugene
State/Province
Oregon
Country
United States
Facility Name
Oregon Center For Clinical Investigations, Inc.
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Summit Research Network
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Oregon Center for Clinical Investigations, Inc.
City
Salem
State/Province
Oregon
Country
United States
Facility Name
ADHD Program, Western Psychiatric Institute and Clinic
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
The Jackson Clinic
City
Jackson
State/Province
Tennessee
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
FutureSearch Trials
City
Austin
State/Province
Texas
Country
United States
Facility Name
Claghorn-Lesem Research Clinic Inc.
City
Bellaire
State/Province
Texas
Country
United States
Facility Name
Red Oak Psychiatry Associates P.A.
City
Houston
State/Province
Texas
Country
United States
Facility Name
R/D Clinical Research, Inc.
City
Lake Jackson
State/Province
Texas
Country
United States
Facility Name
ADHD Clinic of San Antonio
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
NeuroScience, Inc
City
Herndon
State/Province
Virginia
Country
United States
Facility Name
Dominion Clinical Research
City
Midlothian
State/Province
Virginia
Country
United States
Facility Name
International Clinical Research Associates, LLC
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Eastside Therapeutic Resource
City
Kirkland
State/Province
Washington
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20035583
Citation
Findling RL, Ginsberg LD, Jain R, Gao J. Effectiveness, safety, and tolerability of lisdexamfetamine dimesylate in children with attention-deficit/hyperactivity disorder: an open-label, dose-optimization study. J Child Adolesc Psychopharmacol. 2009 Dec;19(6):649-62. doi: 10.1089/cap.2008.0165.
Results Reference
result
PubMed Identifier
21173426
Citation
Katic A, Ginsberg L, Jain R, Adeyi B, Dirks B, Babcock T, Scheckner B, Richards C, Lasser R, Turgay A, Findling RL. Clinically relevant changes in emotional expression in children with ADHD treated with lisdexamfetamine dimesylate. J Atten Disord. 2012 Jul;16(5):384-97. doi: 10.1177/1087054710389990. Epub 2010 Dec 20.
Results Reference
result
PubMed Identifier
21186969
Citation
Turgay A, Ginsberg L, Sarkis E, Jain R, Adeyi B, Gao J, Dirks B, Babcock T, Scheckner B, Richards C, Lasser R, Findling RL. Executive function deficits in children with attention-deficit/hyperactivity disorder and improvement with lisdexamfetamine dimesylate in an open-label study. J Child Adolesc Psychopharmacol. 2010 Dec;20(6):503-11. doi: 10.1089/cap.2009.0110.
Results Reference
result
Links:
URL
http://www.fda.gov/opacom/7alerts.html
Description
FDA recall information
URL
http://www.vyvanse.com/pdf/prescribing_information.pdf
Description
FDA-approved label
Learn more about this trial
Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (Lisdexamfetamine Dimesylate) in Children Aged 6-12 Diagnosed With ADHD
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