Attention Deficit Hyperactivity DisorderPhase 3NCT02457819
Dasotraline Pediatric Extension Study
A Phase 3 study testing Dasotraline in people with Attention Deficit Hyperactivity Disorder, run by Sumitomo Pharma America, Inc. at 36 sites in United States.
Trial summary
This is an open label 26 week extension study for subjects who completed SEP360-202. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Dasotraline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- 36 sitesUnited States
- Study dates
- 30 Jun 2015to 2 Feb 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- At least one of the subject's parent/legal guardian must give written informed consent, including privacy authorization, prior to study participation. The subject will complete an informed assent prior to study participation.
- Subject and subject's parent/legal guardian are judged by the investigator to be willing and able to comply with the study procedures and visit schedules.
- Subject has completed all required assessments for Week 6 of the core study.
- Subject has not taken any medication other than the study drug for the purpose of controlling ADHD symptoms during the core study.
- Subject, if female, must not be pregnant or breastfeeding.
- Female subject: must be unable to become pregnant (eg, premenarchal, surgically sterile, etc);
Show all 12Show fewer
- -OR-
- practice true abstinence (consistent with lifestyle) and must agree to remain abstinent from signing informed consent/assent to at least 14 days after the last dose of study drug has been taken; -OR-
- is sexually active and willing to use a medically effective method of birth control from signing informed consent/assent to at least 14 days after the last dose of study drug has been taken.
- Male subject must be willing to remain sexually abstinent (consistent with lifestyle) or use an effective method of birth control, from signing informed consent/assent to at least 14 days after the last dose of study drug has been taken.
- Any subject whose weight is less than or equal to 21 kg at the OL Baseline visit should be discussed with the medical monitor prior to enrollment.
- Subject and subject's parent/legal guardian must be able to fully comprehend the informed consent/assent form (as applicable), understand all study procedures, and be able to communicate satisfactorily with the Investigator and study coordinator.
Who cannot join
- -Subject is considered by the investigator to be at imminent risk of suicide, injury to self or to others, or damage to property.
- Subject answers "yes" to "Suicidal Ideation" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) for any lifetime history on the C SSRS Children's "Since Last Visit" assessment at OL Baseline.
- Subject has a clinically significant abnormality including physical examination, vital signs, ECG, or laboratory tests that the investigator in consultation with the medical monitor considers to be inappropriate to allow participation in the study.
- Subject has a positive urine drug screen (UDS) or breath alcohol test at OL Baseline.
- Subject or parents/legal guardian has commitments during the study that would interfere with attending study visits.
- Subject is at high risk of non-compliance in the investigator's opinion.
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
United States36 sites
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
BioBehavioral Research of Austin P.C.
Austin, Texas, 78759
Neurobehavioral Medicine Group, Clinical Trials Division
Bloomfield Hills, Michigan, 48302
University of Cincinnati/Department of Psychiatry and Behavioral Neuroscience
Cincinnati, Ohio, 45219
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
MCB Clinical Research Centers, LLC
Colorado Springs, Colorado, 80910
ProScience Research Group
Culver City, California, 90230
iResearch Atlanta, LLC
Decatur, Georgia, 30030
Harmonex Neuroscience Research, Inc
Dothan, Alabama, 36303
Sarkis Clinical Trials
Gainesville, Florida, 32607
Cyn3rgy Research
Gresham, Oregon, 97030
Indago Research Health Center, Inc.
Hialeah, Florida, 33012
Bayou City Research, Ltd.
Houston, Texas, 77007
Houston Clinical Trials, LLC
Houston, Texas, 77098
Goldpoint Clinical Research, LLC.
Indianapolis, Indiana, 46260
Clinical Neuroscience Solutions, Inc
Jacksonville, Florida, 32256
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, 89128
Capstone Clinical Research
Libertyville, Illinois, 60418
Florida Clinical Research Center, LLC
Maitland, Florida, 32751
Pharmaceutical Research Associates, Inc.
Marlton, New Jersey, 08053
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Baber Research Group, Inc.
Naperville, Illinois, 630-896-3530
Pedia Research,LLC
Newburgh, Indiana, 47630
IPS Research Company
Oklahoma City, Oklahoma, 73103
Cutting Edge Research Group
Oklahoma City, Oklahoma, 73116
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801
Psychiatric Associates
Overland Park, Kansas, 66211
Pedia Research,LLC
Owensboro, Kentucky, 42301
Clinical Trials group at the Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, 48307
St. Charles Psychiatric Associates - Midwest Research Group
Saint Charles, Missouri, 63304
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
Road Runner Research, Ltd.
San Antonio, Texas, 78258
Miami Research Associates, LLC
South Miami, Florida, 33143
Richarmond Behavioral Associates
Staten Island, New York, 10312
Family Psychiatry of the Woodlands
The Woodlands, Texas, 77381
Elite Clinical Trials, Inc.
Wildomar, California, 92595
About this study
Official title: An Open-label, Flexibly-dosed, 26-Week Extension Safety Study of Dasotraline in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
This is an open label 26 week extension study for subjects who completed SEP360-202.
Read the detailed description
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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Dasotraline
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DasotralineDrug
Dasotraline 2 mg, 4 mg, 6 mg, once daily, flexibly dosed
| Study group | Role | What they receive |
|---|---|---|
| Dasotraline | Experimental | Dasotraline 2, 4, 6 mg Receives: Drug: Dasotraline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 26 Weeks
Secondary outcomes (2)
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).
Measured: 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.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study start30 Jun 2015
- Primary completion2 Feb 2017
- Study completion2 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dasotraline Medical Director, Study director, Sumitomo Pharma America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02457819
- Sponsor's protocol ID
- SEP360-310
- Status last verified
- Jan 2020
- First submitted
- 20 May 2015
- Last updated
- 28 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Flexibly-dosed, 26-Week Extension Safety Study of Dasotraline in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT02457819
- Acronym / sponsor ID
- SEP360-310
- Conditions
- Attention Deficit Hyperactivity Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2015 (actual)
- Primary completion
- 2 Feb 2017 (actual)
- Study completion
- 2 Feb 2017 (actual)
- First posted
- 29 May 2015 (estimated)
- Results
- Posted 18 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open label 26 week extension study for subjects who completed SEP360-202.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dasotraline | Experimental | Drug: DasotralineDasotraline 2, 4, 6 mg |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- At least one of the subject's parent/legal guardian must give written informed consent, including privacy authorization, prior to study participation. The subject will complete an informed assent prior to study participation.
- Subject and subject's parent/legal guardian are judged by the investigator to be willing and able to comply with the study procedures and visit schedules.
- Subject has completed all required assessments for Week 6 of the core study.
- Subject has not taken any medication other than the study drug for the purpose of controlling ADHD symptoms during the core study.
- Subject, if female, must not be pregnant or breastfeeding.
Key exclusion criteria (6 listed)
- -Subject is considered by the investigator to be at imminent risk of suicide, injury to self or to others, or damage to property.
- Subject answers "yes" to "Suicidal Ideation" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) for any lifetime history on the C SSRS Children's "Since Last Visit" assessment at OL Baseline.
- Subject has a clinically significant abnormality including physical examination, vital signs, ECG, or laboratory tests that the investigator in consultation with the medical monitor considers to be inappropriate to allow participation in the study.
- Subject has a positive urine drug screen (UDS) or breath alcohol test at OL Baseline.
- Subject or parents/legal guardian has commitments during the study that would interfere with attending study visits.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DasotralineDasotraline 2 mg, 4 mg, 6 mg, once daily, flexibly dosed | Drug | Dasotraline |
Primary outcome
The Incidence of Overall Adverse Events, AEs , Serious Adverse Envents,(or SAEs), and AEs (or SAEs) Leading to Discontinuation
Time frame: 26 Weeks
Overall adverse events, AEs , serious adverse envents,(or SAEs), and AEs (or SAEs) leading to discontinuation.
2 secondary outcomes
Change From Baseline, in Attention Deficit Hyperactivity Disorder Rating Scale, Version IV, Home Version, (ADHD RS IV HV) Total Score.
Time frame: 26 Weeks
Change From Baseline, in Clinical Global Impression-Severity of Illness (CGI S) Score.
Time frame: 26 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dasotraline Medical Director study director
Sumitomo Pharma America, Inc.
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dasotraline in people with Attention Deficit Hyperactivity Disorder, run by Sumitomo Pharma America, Inc. at 36 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Incidence of Overall Adverse Events, AEs , Serious Adverse Envents,(or SAEs), and AEs (or SAEs) Leading to Discontinuation (time frame: 26 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2020.