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The primary objective of this study is to evaluate the maintenance of efficacy, as measured by Adult ADHD Rating Scale with Prompts (Adult ADHD-RS with prompts) and Clinical Global Impression - Severity (CGI-S) scores, through a randomized withdrawal design when subjects with ADHD have been on stable treatment with commercial SPD489 for a minimum of 6 months and are maintained on their screening dose of commercial SPD489.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPD489 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPD489 (Lisdexamfetamine dimesylate) | Drug | 1 capsule (either 30, 50, or 70mg strength) per day for 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Treatment Failures at up to 6 Weeks | Treatment failure defined as > or equal to 50% increase in the ADHD-RS with adult prompts total score and a > or equal to 2 point increase in the CGI-S score. | Up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) With Adult Prompts Total Score at up to 6 Weeks | The ADHD-RS 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. | Up to 6 weeks |
| Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at up to 6 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 |
|---|---|---|---|
| 22780921 | Result | Brams M, Weisler R, Findling RL, Gasior M, Hamdani M, Ferreira-Cornwell MC, Squires L. Maintenance of efficacy of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder: randomized withdrawal design. J Clin Psychiatry. 2012 Jul;73(7):977-83. doi: 10.4088/JCP.11m07430. Epub 2012 Jun 12. | |
| 25295648 | Derived |
| Label | URL |
|---|---|
| FDA Recall Information | View source |
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Subjects had been on stable treatment with commercial SPD489 (30, 50, or 70 mg/day) for at least 6 months. They then entered a 3-week open-label treatment phase on SPD489 (30, 50, or 70 mg/day). They then entered a 6-week double-blind randomized withdrawal phase where they were assigned to either SPD489 or placebo treatment group.
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| ID | Title | Description |
|---|---|---|
| FG000 | SPD489 | Subjects receive SPD489 at 30, 50, or 70 mg/day. |
| FG001 | Placebo | Subjects who previously were receiving SPD489 are now only getting placebo. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Open-label Treatment Phase |
|
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| Placebo | Drug | 1 capsule (identical to drug capsules) per day for 4 weeks during the double blind period. |
|
CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill) |
| Up to 6 weeks |
| El Centro |
| California |
| 92243 |
| United States |
| Peninsula Research Associates, Inc | Rolling Hills Estates | California | 90274 | United States |
| PCSD Feighner Research | San Diego | California | 92108 | United States |
| Elite Clinical Trials, Inc. | Wildomar | California | 92595 | United States |
| Colorado Clinica Trials, Inc. | Highlands Ranch | Colorado | 80130 | United States |
| Florida Clinical Research Center | Bradenton | Florida | 34208 | United States |
| Gulfcoast Clinical Research Center | Fort Myers | Florida | 33912 | United States |
| Clinical Neuroscience Solutions Inc | Jacksonville | Florida | 32216 | United States |
| Fidelity Clinical Research, Inc. | Lauderhill | Florida | 33319 | United States |
| CNS Healthcare | 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 | Roswell | Georgia | 30076 | United States |
| Joliet Center for Clinical Research | Joliet | Illinois | 60435 | United States |
| Capstone Clinical Research | Libertyville | Illinois | 60048 | United States |
| CIENTIFICA, Inc | Newton | Kansas | 67114 | United States |
| Psychiatric Associates | Overland Park | Kansas | 66211 | United States |
| Vince and Associates Clinical Research | Overland Park | Kansas | 66212 | United States |
| Clinical Trial Technology Inc. | Prairie Village | Kansas | 66206 | United States |
| Pedia Research LLC | Owensboro | Kentucky | 42301 | United States |
| Four Rivers Clinical Research | Paducah | Kentucky | 42003 | United States |
| Rockville | Maryland | 20852 | United States |
| Rochester Center for Behavioral Medicine | Rochester Hills | Michigan | 48307 | United States |
| The Behavioral Medicine Clinic of NW Michigan | Traverse City | Michigan | 49686 | United States |
| Behavioral Medical Center-Troy | Troy | Michigan | 48083 | United States |
| Midwest Research Group/ St. Charles Psychiatric Associates | Saint Charles | Missouri | 63301 | United States |
| Premier Psychiatric Research Institute, LLC | Lincoln | Nebraska | 68510 | United States |
| Center for Psychiatry and Behavioral Medicine Inc. | Las Vegas | Nevada | 89128 | United States |
| Center for Emotional Fitness | Cherry Hill | New Jersey | 08002 | United States |
| Global Medical Institutes, LLC. Princeton Medical Institute | Princeton | New Jersey | 08540 | United States |
| Richmond Behavioral Associates | Staten Island | New York | 10312 | United States |
| Richard H. Weisler, MD, PA & Associates | Raleigh | North Carolina | 27609 | United States |
| Prarie St. Johns/ Odyssey Research | Fargo | North Dakota | 58104 | United States |
| UHCMC/ Discovery and Wellness Center for Children | Cleveland | Ohio | 44106 | United States |
| IPS Research Company | Oklahoma City | Oklahoma | 73703 | United States |
| Calcagno Pediatrics | Gresham | Oregon | 97030 | United States |
| Introspect of Buxmont, Ltd. | Colmar | Pennsylvania | 18915 | United States |
| Youth and Family Research Program | Pittsburgh | Pennsylvania | 15213 | United States |
| Carolina Clinical Trials, Inc. | Charleston | South Carolina | 29407 | United States |
| CNS Healthcare | Memphis | Tennessee | 38119 | United States |
| FutureSearch Trials | Austin | Texas | 78756 | United States |
| FutureSearch Trials of Dallas, LP | Dallas | Texas | 75231 | United States |
| Bayou City Reserch, Ltd. | Houston | Texas | 77007 | United States |
| Westex Clinical Investigators | Lubbock | Texas | 79423 | United States |
| Cerebral Research, LLC | San Antonio | Texas | 78247 | United States |
| Aspen Clinical Research | Orem | Utah | 84058 | United States |
| Vermont Clinical Study Center | Burlington | Vermont | 05401 | United States |
| Neuropsychiatric Associates | Woodstock | Vermont | 05091 | United States |
| Psychiatric Alliance of the Blue Ridge | Charlottesville | Virginia | 22903 | United States |
| Dominion Clinical Research | Midlothian | Virginia | 23112 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98004 | United States |
| Eastside Therapeutic Resource | Kirkland | Washington | 98033 | United States |
| Dean Foundation | Middleton | Wisconsin | 53562 | United States |
| Weisler RH, Babcock T, Adeyi B, Brams M. Relationship of ADHD symptoms and global illness severity in adults treated with lisdexamfetamine dimesylate. Postgrad Med. 2014 Sep;126(5):31-41. doi: 10.3810/pgm.2014.09.2798. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Double-blind Randomized Withdrawal Phase |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SPD489 | Subjects receive SPD489 at 30, 50, or 70 mg/day. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Age, Customized | The demographics are based on the safety population defined as all subjects who entered the open-label treatment phase and took at least 1 dose of investigational product (SPD489). 123 subjects enrolled into the study, but 1 subject withdrew prior to receiving a dose of investigational product in the open-label treatment phase. Therefore, 122 subjects are in the safety population. | 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) With Adult Prompts Total Score at up to 6 Weeks | The ADHD-RS 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. | FAS | Posted | Least Squares Mean | Standard Error | Units on a scale | Up to 6 weeks |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at up to 6 Weeks | CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill) | FAS | Posted | Number | Percent of Participants | Up to 6 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percent of Treatment Failures at up to 6 Weeks | Treatment failure defined as > or equal to 50% increase in the ADHD-RS with adult prompts total score and a > or equal to 2 point increase in the CGI-S score. | Full Analysis Set (FAS) defined as all subjects who were randomized and received at least 1 dose of investigational product. | Posted | Number | Percent of participants | Up to 6 weeks |
|
|
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Safety Population defined as all subjects who entered the open-label treatment phase and took at least 1 dose of investigational product (SPD489).
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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 | SPD489 | Subjects receive SPD489 at 30, 50, or 70 mg/day. | 0 | 56 | 16 | 56 | ||
| EG001 | Placebo | Subjects who previously were receiving SPD489 are now only getting placebo. | 1 | 60 | 6 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal ideation | Psychiatric disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders |
| |||
| Insomnia | Psychiatric disorders |
| |||
| Upper respiratory tract infection | Infections and infestations |
|
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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| Protocol Violation |
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| Moved out of state |
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