Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Assess the efficacy & tolerability of Vyvanse when children aged 6-12 years diagnosed with ADHD are dosed to optimal effect.
Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (lisdexamfetamine dimesylate) in Children aged 6-12 Diagnosed with ADHD
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vyvanse (lisdexamfetamine dimesylate) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 1, 2, 3, 4, 5, 6, and 7 weeks |
Not provided
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Melmed Center | Scottsdale | Arizona | United States | |||
| Valley Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20035583 | Result | 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. | |
| 21173426 | Result |
| Label | URL |
|---|---|
| FDA recall information | View source |
Not provided
The study had three phases; 1)screening and wash-out; 2) dose-optimization (5 weeks) and maintenance (2 weeks); 3) 30-day safety follow-up. Dosing ranged from 20-70 mg once daily of Vyvanse.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Vyvanse | Lisdexamfetamine dimesylate (LDX) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Screening and Washout Phase |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | 7 weeks |
| 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. | 7 weeks |
| 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. | Baseline and 7 weeks |
| 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. | Baseline and 7 weeks |
| El Centro |
| California |
| United States |
| Peninsula Research Assoc, Inc | Rolling Hills Estates | California | United States |
| UCSF-Langely Porter Psych Institute | San Francisco | California | United States |
| Encompass Clinical Research | Spring Valley | California | United States |
| Shire Clinical Research Site | Wildomar | California | United States |
| Sarkis Clinical Trials | Gainesville | Florida | United States |
| Shire Clinical Research Site | Hialeah | Florida | United States |
| CNS Research Institute, Inc | Jacksonville | Florida | United States |
| CORE Research, Inc | Maitland | Florida | United States |
| Miami Research Associates | Miami | Florida | United States |
| Clinical Neuroscience Solutions, Inc | Orlando | Florida | United States |
| Janus Center for Psychiatric Research | West Palm Beach | Florida | United States |
| Children's Development Center | Winter Park | Florida | United States |
| Capstone Clinical Research | Libertyville | Illinois | United States |
| Indiana University School of Medicine | Indianapolis | Indiana | United States |
| Shire Clinical Research Site | Terre Haute | Indiana | United States |
| Shire Clinical Research Site | Newton | Kansas | United States |
| Psychiatric Associates | Overland Park | Kansas | United States |
| Kentucky Pediatric/Adult Research | Bardstown | Kentucky | United States |
| Shire Clinical Research Site | Lexington | Kentucky | United States |
| Pedia Research | Owensboro | Kentucky | United States |
| Four Rivers Clinical Research, Inc. | Paducah | Kentucky | United States |
| Shire Clinical Research Site | Troy | Michigan | United States |
| University of Rochester, School of Medicine and Dentistry | Rochester | New York | United States |
| Piedmont Neuropsychiatry | Charlotte | North Carolina | United States |
| University Commons Office Park | Durham | North Carolina | United States |
| University Hospitals of Cleveland | Cleveland | Ohio | United States |
| BHI, Inc. | Moore | Oklahoma | United States |
| Shire Clinical Research Site | Oklahoma City | Oklahoma | United States |
| Oregon Center for Clinical Investigations, Inc | Eugene | Oregon | United States |
| Oregon Center For Clinical Investigations, Inc. | Portland | Oregon | United States |
| Summit Research Network | Portland | Oregon | United States |
| Oregon Center for Clinical Investigations, Inc. | Salem | Oregon | United States |
| ADHD Program, Western Psychiatric Institute and Clinic | Pittsburgh | Pennsylvania | United States |
| The Jackson Clinic | Jackson | Tennessee | United States |
| Clinical Neuroscience Solutions, Inc | Memphis | Tennessee | United States |
| FutureSearch Trials | Austin | Texas | United States |
| Claghorn-Lesem Research Clinic Inc. | Bellaire | Texas | United States |
| Red Oak Psychiatry Associates P.A. | Houston | Texas | United States |
| R/D Clinical Research, Inc. | Lake Jackson | Texas | United States |
| ADHD Clinic of San Antonio | San Antonio | Texas | United States |
| NeuroScience, Inc | Herndon | Virginia | United States |
| Dominion Clinical Research | Midlothian | Virginia | United States |
| International Clinical Research Associates, LLC | Richmond | Virginia | United States |
| Eastside Therapeutic Resource | Kirkland | Washington | United States |
| 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. |
| 21186969 | Result | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Dose-optimization and Maintenance Phase |
|
|
| 30-day Safety Follow-up |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Vyvanse | Lisdexamfetamine dimesylate (LDX) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | 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. | ITT | Posted | Mean | Standard Error | Units on a scale | Baseline and 1, 2, 3, 4, 5, 6, and 7 weeks |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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. | Intent-to-treat (ITT). ITT population defined as all subjects who took at least one dose of drug and had at least one ADHD-RS-IV total score available. | Posted | Mean | Standard Error | Units on a scale | Baseline and 7 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT | Posted | Number | Participants | 7 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT | Posted | Number | Participants | 7 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Baseline and 7 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Baseline and 7 weeks |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vyvanse | Lisdexamfetamine dimesylate (LDX) | 2 | 317 | 269 | 317 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Syncope | Cardiac disorders | Non-systematic Assessment |
| ||
| Sinus arrest | Cardiac disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Irritability | General disorders | Non-systematic Assessment |
| ||
| Weight decreased | Investigations | Non-systematic Assessment |
| ||
| Decreased appetite | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Affect liability | Psychiatric disorders | Non-systematic Assessment |
| ||
| Initial insomnia | Nervous system disorders | Non-systematic Assessment |
| ||
| Insomnia | Nervous system disorders | Non-systematic Assessment |
|
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069478 | Lisdexamfetamine Dimesylate |
| ID | Term |
|---|---|
| D003913 | Dextroamphetamine |
| D000661 | Amphetamine |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Withdrawal by Subject |
|
| Lack of protocol compliance |
|
| Title | Measurements |
|---|---|
|
| Week 4 |
|
| Week 5 |
|
| Week 6 |
|
| Week 7 |
|
| 95 |
| Superiority or Other (legacy) |
| Week 3 | t-test, 1 sided | < 0.0001 | 95 | Superiority or Other (legacy) |
| Week 4 | t-test, 1 sided | < 0.0001 | 95 | Superiority or Other (legacy) |
| Week 5 | t-test, 1 sided | < 0.0001 | 95 | Superiority or Other (legacy) |
| Week 6 | t-test, 1 sided | < 0.0001 | 95 | Superiority or Other (legacy) |
| Week 7 | t-test, 1 sided | < 0.0001 | 95 | Superiority or Other (legacy) |
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|
|
|