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The primary objective of this study is to evaluate the long-term safety of LDX administered as a daily morning dose (30, 50, and 70 mg/day) in the treatment of adolescents (13-17 years of age inclusive at the time of consent).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LDX | Experimental | Lisdexamfetamine Dimesylate (LDX) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lisdexamfetamine Dimesylate (LDX) | Drug | optimal dose of 30, 50 or 70 mg once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline (From the Antecedent Study, SPD489-305) in the Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at up to 52 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 up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants With Improvement in 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 (very much improved) or 2 (much improved) on the scale. | up to 52 weeks |
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Exclusion
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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 |
|---|---|---|---|
| 23410138 | Result | Findling RL, Cutler AJ, Saylor K, Gasior M, Hamdani M, Ferreira-Cornwell MC, Childress AC. A long-term open-label safety and effectiveness trial of lisdexamfetamine dimesylate in adolescents with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2013 Feb;23(1):11-21. doi: 10.1089/cap.2011.0088. |
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269 subjects were enrolled, but 4 were not dosed during the study and thus excluded from the Safety Population.
Subjects had to have satisfied all entry criteria for the antecedent study (SPD489-305, NCT00735371) and completed a minimum of 3 weeks of double-blind treatment and reached Visit 3 of the antecedent study (SPD489-305), without experiencing any clinically significant adverse events that would preclude exposure to LDX.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lisdexamfetamine Dimesylate (LDX) | Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Change From Baseline (From the Antecedent Study, SPD489-305) in the Youth Quality of Life Instrument-Research Version (YQOL-R) Total Score at up to 52 Weeks |
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 Up to 52 weeks |
| El Centro |
| California |
| 92243 |
| United States |
| Penninsula 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 | 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 | 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 (Oregon Center for Clinical Investigations, Inc.) | Salem | Oregon | 97301 | United States |
| CRI Worldwide | Philadelphia | Pennsylvania | 19139 | United States |
| Youth and Family Research Program/WPIC ADHD Research Program | Pittsburgh | Pennsylvania | 15213 | United States |
| CNS Healthcare | Memphis | Tennessee | 38119 | United States |
| Future Search Trials | Austin | Texas | 78756 | United States |
| Bayou City Research, Ltd. | Houston | Texas | 77007 | United States |
| Red Oak Psychiatry Associates P.A. | 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Lisdexamfetamine Dimesylate (LDX) | Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Baseline characteristics were calculated from the Safety Population (n = 265) defined as all randomized subjects who received at least 1 dose of investigational product. Baseline and demographic characteristics are calculated from entry into the antecedent study (SPD489-305, NCT00735371). | Mean | Standard Deviation | years |
| |||||||||||||||||||||
| Age, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| 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 (From the Antecedent Study, SPD489-305) in the Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at up to 52 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) defined as all subjects who took at least 1 dose of investigational product and have a valid baseline and at least 1 valid follow-up assessment of the primary outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and up to 52 weeks |
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| Secondary | Percent of Participants With Improvement in 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 (very much improved) or 2 (much improved) on the scale. | FAS | Posted | Number | Percent of participants | up to 52 weeks |
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| Secondary | Change From Baseline (From the Antecedent Study, SPD489-305) in the Youth Quality of Life Instrument-Research Version (YQOL-R) Total Score at up to 52 Weeks | 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 Up to 52 weeks |
|
|
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Safety population is defined as all subjects who take at least 1 dose of investigational product. In the Serious Adverse Events, the same subject reported multiple adverse events.
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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) | Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day). | 10 | 265 | 230 | 265 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hydrocele | Congenital, familial and genetic disorders |
| |||
| Pneumonia | Infections and infestations |
| |||
| Joint Sprain | Injury, poisoning and procedural complications |
| |||
| Pelvic Fracture | Injury, poisoning and procedural complications |
| |||
| Traumatic Liver Injury | Injury, poisoning and procedural complications |
| |||
| Wrist Fracture | Injury, poisoning and procedural complications |
| |||
| Syncope | Nervous system disorders |
| |||
| Syncope Vasovagal | Nervous system disorders |
| |||
| Ectopic Pregnancy | Pregnancy, puerperium and perinatal conditions |
| |||
| Aggression | Psychiatric disorders |
| |||
| Testicular Torsion | Reproductive system and breast disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry Mouth | Gastrointestinal disorders |
| |||
| Irritability | General disorders |
| |||
| Influenza | Infections and infestations |
| |||
| Nasopharyngitis | Infections and infestations |
| |||
| Upper Respiratory Tract Infection | Infections and infestations |
| |||
| Weight Decreased | Investigations |
| |||
| Decreased Appetite | Metabolism and nutrition disorders |
| |||
| Dizziness | Nervous system disorders |
| |||
| Headache | Nervous system disorders |
| |||
| Insomnia | Psychiatric disorders |
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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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