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This is an open label 26 week extension study for subjects who completed SEP360-202.
This is an open-label, flexibly-dosed, 26 week extension study in children and adolescents with ADHD who have completed 6 weeks of double-blind treatment in the core study (SEP360 202). This study will evaluate the long-term safety and tolerability of dasotraline in this population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dasotraline | Experimental | Dasotraline 2, 4, 6 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dasotraline | Drug | Dasotraline 2 mg, 4 mg, 6 mg, once daily, flexibly dosed |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Incidence of Overall Adverse Events, AEs , Serious Adverse Envents,(or SAEs), and AEs (or SAEs) Leading to Discontinuation | Overall adverse events, AEs , serious adverse envents,(or SAEs), and AEs (or SAEs) leading to discontinuation. | 26 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline, in Attention Deficit Hyperactivity Disorder Rating Scale, Version IV, Home Version, (ADHD RS IV HV) Total Score. | The ADHD RS-IV HV is a validated scale that consists of 18 items designed to reflect current symptomatology of ADHD based on Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria and is also consistent with DSM-5 criteria. Each item is scored from a range of zero (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from zero to 54. The 18 items may be grouped into 2 subscales: hyperactivity/impulsivity (even number items 2 through 18) and inattentiveness (odd number items 1 through 17). |
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Inclusion Criteria:
-OR-
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dasotraline Medical Director | Sumitomo Pharma America, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harmonex Neuroscience Research, Inc | Dothan | Alabama | 36303 | United States | ||
| ProScience Research Group |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dasotraline | Dasotraline 2, 4, 6 mg, flexibly dosed |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 20, 2016 | Jan 3, 2020 |
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Open label
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| 26 Weeks |
| Change From Baseline, in Clinical Global Impression-Severity of Illness (CGI S) Score. | The CGI-S scale, modified captures the clinician's rating of observed and reported ADHD symptoms, behavior, and function over the past 7 days. The CGI-S is rated on the following 7-point scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill subjects. | 26 weeks |
| Culver City |
| California |
| 90230 |
| United States |
| Elite Clinical Trials, Inc. | Wildomar | California | 92595 | United States |
| MCB Clinical Research Centers, LLC | Colorado Springs | Colorado | 80910 | United States |
| Sarkis Clinical Trials | Gainesville | Florida | 32607 | United States |
| Indago Research Health Center, Inc. | Hialeah | Florida | 33012 | United States |
| Clinical Neuroscience Solutions, Inc | Jacksonville | Florida | 32256 | United States |
| Florida Clinical Research Center, LLC | Maitland | Florida | 32751 | United States |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32801 | United States |
| Miami Research Associates, LLC | South Miami | Florida | 33143 | United States |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | United States |
| iResearch Atlanta, LLC | Decatur | Georgia | 30030 | United States |
| Capstone Clinical Research | Libertyville | Illinois | 60418 | United States |
| Baber Research Group, Inc. | Naperville | Illinois | 630-896-3530 | United States |
| Goldpoint Clinical Research, LLC. | Indianapolis | Indiana | 46260 | United States |
| Pedia Research,LLC | Newburgh | Indiana | 47630 | United States |
| Psychiatric Associates | Overland Park | Kansas | 66211 | United States |
| Pedia Research,LLC | Owensboro | Kentucky | 42301 | United States |
| Neurobehavioral Medicine Group, Clinical Trials Division | Bloomfield Hills | Michigan | 48302 | United States |
| Clinical Trials group at the Rochester Center for Behavioral Medicine | Rochester Hills | Michigan | 48307 | United States |
| St. Charles Psychiatric Associates - Midwest Research Group | Saint Charles | Missouri | 63304 | United States |
| Center for Psychiatry and Behavioral Medicine, Inc. | Las Vegas | Nevada | 89128 | United States |
| Pharmaceutical Research Associates, Inc. | Marlton | New Jersey | 08053 | United States |
| Richarmond Behavioral Associates | Staten Island | New York | 10312 | United States |
| University of Cincinnati/Department of Psychiatry and Behavioral Neuroscience | Cincinnati | Ohio | 45219 | United States |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
| IPS Research Company | Oklahoma City | Oklahoma | 73103 | United States |
| Cutting Edge Research Group | Oklahoma City | Oklahoma | 73116 | United States |
| Cyn3rgy Research | Gresham | Oregon | 97030 | United States |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | 29464 | United States |
| BioBehavioral Research of Austin P.C. | Austin | Texas | 78759 | United States |
| Bayou City Research, Ltd. | Houston | Texas | 77007 | United States |
| Houston Clinical Trials, LLC | Houston | Texas | 77098 | United States |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | United States |
| Road Runner Research, Ltd. | San Antonio | Texas | 78258 | United States |
| Family Psychiatry of the Woodlands | The Woodlands | Texas | 77381 | United States |
| Safety Population |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dasotraline | Dasotraline 2, 4, 6 mg, flexibly dosed |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | United States | Number | participants |
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| 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 | The Incidence of Overall Adverse Events, AEs , Serious Adverse Envents,(or SAEs), and AEs (or SAEs) Leading to Discontinuation | Overall adverse events, AEs , serious adverse envents,(or SAEs), and AEs (or SAEs) leading to discontinuation. | safety population | Posted | Number | adverse events | 26 Weeks |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline, in Attention Deficit Hyperactivity Disorder Rating Scale, Version IV, Home Version, (ADHD RS IV HV) Total Score. | The ADHD RS-IV HV is a validated scale that consists of 18 items designed to reflect current symptomatology of ADHD based on Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria and is also consistent with DSM-5 criteria. Each item is scored from a range of zero (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from zero to 54. The 18 items may be grouped into 2 subscales: hyperactivity/impulsivity (even number items 2 through 18) and inattentiveness (odd number items 1 through 17). | safety population | Posted | Mean | Standard Deviation | units on a scale | 26 Weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline, in Clinical Global Impression-Severity of Illness (CGI S) Score. | The CGI-S scale, modified captures the clinician's rating of observed and reported ADHD symptoms, behavior, and function over the past 7 days. The CGI-S is rated on the following 7-point scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill subjects. | safety population | Posted | Mean | Standard Deviation | units on a scale | 26 weeks |
|
|
26 weeks
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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 | Dasotraline | Dasotraline 2, 4, 6 mg, flexibly dosed | 0 | 236 | 3 | 236 | 94 | 236 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyelonephritis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Psychomotor hyperactivity | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Panic attack | Product Issues | MedDRA 19.0 | Systematic Assessment |
| |
| Substance-induced psychotic disorder | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Suicidal ideatin | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Weight decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Decreased apppetite | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Anxiety | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Initial insomnia | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Irritability | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
|
In the event the Study is part of a multi-center study, the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| CNS Medical Director | Sunovion Pharmaceuticals Inc. | 1-866-503-6351 | ClinicalTrialDisclosure@sunovion.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 9, 2017 | Jan 3, 2020 | SAP_001.pdf |
| 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 |
|---|---|
| C000609455 | 4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydronaphthalen-1-amine |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
|
| Subjects with any serious treatment-related TEAE |
|
| treatment-related TEAE leading to discontinuation |
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