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The study will evaluate the efficacy of LDX treatment group compared to placebo on the change from Baseline ADHD-RS-IV score at endpoint.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lisdexamfetamine Dimesylate (LDX) 30 mg | Active Comparator |
| |
| LDX 50 mg | Active Comparator |
| |
| LDX 70 mg | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LDX 30 mg | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Study Centers, LLC | Little Rock | Arkansas | 72205 | United States | ||
| Valley Clinical Research, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21421179 | Result | 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. |
| Label | URL |
|---|---|
| FDA recall information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lisdexamfetamine Dimesylate (LDX) 30 mg | Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
|
| LDX 50 mg | Drug | 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 | Drug | 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 | Drug | Placebo will be identical to test product. |
|
| 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 |
| 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 |
| LDX 50 mg |
Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (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. |
| FG002 | LDX 70 mg | Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (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. |
| FG003 | Placebo | Placebo |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lisdexamfetamine Dimesylate (LDX) 30 mg | Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (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. |
| BG001 | LDX 50 mg | Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (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. |
| BG002 | LDX 70 mg | Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (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. |
| BG003 | Placebo | Placebo |
| BG004 | Total | Total of all reporting groups |
| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Full Analysis Set (FAS) is defined as all subjects who took at least one dose of study medication and had a valid Baseline and at least one post-Baseline follow-up assessment of the primary outcome measure (ADHD-RS-IV Total Score) | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline and 1, 2, 3 and 4 weeks |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | FAS | Posted | Number | Participants | 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. | FAS | Posted | Mean | Standard Deviation | Units on a scale | Baseline and 4 weeks |
|
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Safety Population defined as all subjects who took at least one dose of study medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lisdexamfetamine Dimesylate (LDX) 30 mg | Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (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. | 0 | 78 | 51 | 78 | ||
| EG001 | LDX 50 mg | Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (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. | 0 | 77 | 53 | 77 | ||
| EG002 | LDX 70 mg | Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (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. | 0 | 78 | 56 | 78 | ||
| EG003 | Placebo | Placebo | 0 | 77 | 38 | 77 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Decreased appetite | Metabolism and nutrition disorders |
| |||
| Headache | Nervous system disorders |
| |||
| Insomnia | Psychiatric disorders |
| |||
| Weight decreased | Investigations |
| |||
| Irritability | General disorders |
| |||
| Fatigue | General disorders |
| |||
| Dizziness | Nervous system disorders |
| |||
| Upper respiratory tract infection | Infections and infestations |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Vomiting | Gastrointestinal disorders |
| |||
| Dry mouth | Gastrointestinal disorders |
| |||
| Nasopharyngitis | Infections and infestations |
| |||
| Nasal congestion | Respiratory, thoracic and mediastinal disorders |
|
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 |
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| ID | Term |
|---|---|
| D000069478 | Lisdexamfetamine Dimesylate |
| ID | Term |
|---|---|
| D003913 | Dextroamphetamine |
| D000661 | Amphetamine |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| 95 |
| Superiority or Other (legacy) |
| ANCOVA | <0.0001 | 95 | Superiority or Other (legacy) |
| OG003 | Placebo | Placebo |
|
|
|
| OG003 | Placebo | Placebo |
|
|