Pediatric Attention Deficit Hyperactivity DisorderPhase 1NCT02195167

Dasotraline SEP360-105 Pediatric PK/PD Study

A Phase 1 study testing Dasotraline 1 mg, 2 mg, 4 mg, 8 mg, 12 mg, 16 mg, 20 mg, 24 mg, 28 mg, 32 mg once daily in people with Pediatric Attention Deficit Hyperactivity Disorder, run by Sumitomo Pharma America, Inc. at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Pediatric PK study of SEP-225289 (Dasotraline) Read more about this study

Who is it for?: Ages 6 to 17 years
Conditions the study is for: Pediatric Attention Deficit Hyperactivity Disorder
What is being tested?: Dasotraline 1 mg, 2 mg, 4 mg, 8 mg, 12 mg, 16 mg, 20 mg, 24 mg, 28 mg, 32 mg once daily
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 105 participants
Where: 12 sitesUnited States
Study dates: Jul 2014to Mar 2015
Phase: Phase 1
Are there results?: None posted in the registry

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 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Subject, male or female, must be between 6 and 17 years of age, inclusive, at the time of consent. Note: Subjects who are 17 years of age at time of consent must not have a birthday within the following 4 weeks in order to be eligible for the study.
Subject meets Diagnostic and Statistical Manual of Mental Disorders Fourth Edition; Text Revision (DSM-IV-TR) criteria for a primary diagnosis of ADHD (inattentive, hyperactive, or combined subtype) established by a comprehensive psychiatric evaluation that reviews DSM-IV-TR criteria prior to Screening. Diagnosis is confirmed at Screening using Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
Subject's parents/legal guardians must give written informed consent, including privacy authorization, prior to study participation. The subject will complete an informed assent prior to study participation. Note: Informed consent will be obtained from both parents unless one parent is deceased, unknown, incompetent, or when one parent has legal responsibility for the care and custody of the child.
Subject and the subject's parents/legal guardians must be judged by the investigator to be willing and able to comply with the study procedures and visit schedules, including venipuncture, overnight stay (recommended for parent/legal guardian to remain overnight with the subject), and follow-up visits.
Subject, if female, must not be pregnant or breastfeeding, and if ≥ 8 years of age must have a negative serum pregnancy test at screening.
Female subjects of childbearing potential and male subjects with female partners of childbearing potential must agree to use an effective and medically acceptable form of birth control throughout the study period.

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Subject must be in general good health (defined as the absence of any clinically relevant abnormalities as determined by the investigator) based on screening physical and neurological examinations, medical history, and clinical laboratory values (hematology, chemistry, and urinalysis). Note: If any of the hematology, chemistry, or urinalysis results are not within the laboratory's reference range, then the subject can be included only if the investigator determines the deviations to be not clinically relevant.
Subject is within 3rd to 97th percentile for gender specific body mass index (BMI)-for-age from the World Health Organization (WHO) growth charts (Appendix VI) and weighs at least 25 kg.
Subject must report a history of being able to swallow capsules.
Subject and subject's parents/legal guardians must be able to fully comprehend the informed consent/assent form, understand all study procedures, and be able to communicate satisfactorily with the investigator and study coordinator.

Who cannot join

Subject or parents/legal guardians have daily commitments during the study that would interfere with attending study visits.
Subject has any clinically significant unstable medical abnormality, chronic disease, or a history of a clinically significant abnormality of the cardiovascular,gastrointestinal, respiratory, hepatic, or renal systems, or a disorder or history of a condition (eg, malabsorption, gastrointestinal surgery) that may interfere with drug absorption, distribution, metabolism, or excretion.
Subject has a history or presence of abnormal ECGs, which in the investigator's opinion is clinically significant. Screening ECGs will be centrally over-read, and eligibility will be determined based on the over-read report.
Subject has a documented history of Bipolar I or II Disorder, major depression, conduct disorder, oppositional defiant disorder, generalized anxiety disorder (other than obsessive-compulsive disorder) or any history of psychosis, that has been the primary focus of treatment at any time during the 12 months prior to screening.
Subject has organic brain disease, for example, traumatic brain injury residua, or a history of febrile seizures. Subjects taking anticonvulsants for seizure control currently or within the past 2 years are not eligible for study participation.
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) on the C-SSRS Children's Lifetime/Recent assessment at screening. Subjects who have significant findings for suicidal ideation upon completion of the C-SSRS must be referred to the investigator for follow-up evaluation.

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Subject has any history of attempted suicide.
Subject does not tolerate venipuncture or has poor venous access that would cause difficulty for collecting blood samples.
Subject has a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions.
Subject has history of exposure to stimulants with intolerable side effects.
Subject has taken any antipsychotic medication within 8 weeks of Visit 1 (Screening).
Subject is taking any psychotropic medication, including health-food supplements with purported central nervous system activity (eg, St. John's Wort, melatonin), must have a washout equal to a minimum of 5 half lives of that medication prior to Visit 2. If the half life of a medication is unknown, for example, herbal products, then the subject should have a 28 day medication washout.
Subject is currently taking an antidepressant medication (eg, bupropion, selective serotonin reuptake inhibitor [SSRI]/ serotonin norepinephrine reuptake inhibitor [SNRI], monoamine oxidase [MAO] blocker, tricyclic, etc).
Subject or subject's family anticipates a move outside the geographic range of the investigative site during the study period, or plans extended travel inconsistent with the recommended visit interval during study duration.
Subject has a history of, or current malignancy except for non melanoma skin cancer.
Subject has a positive screening test for Hepatitis B surface antigen, Hepatitis C antibody, or human immunodeficiency virus (HIV)-1 or HIV-2.
Subject has participated in any investigational study within 30 days prior to screening or is currently participating in another clinical trial.
Subject has a history of substance abuse or drug dependence (excluding nicotine and caffeine) within the 12 months prior to screening, as defined by the DSM IV TR criteria or has a positive urine drug screen (UDS), cotinine test, or breath alcohol test at Visit 1.
Subject is taking any disallowed medications for chronic treatment.
Subject has experienced significant blood loss within 60 days or has donated plasma within 72 hours prior to Visit 1 or intends to donate blood or undergo elective surgery within 30 days following Visit 2.
Subject has a history of allergic reaction or has a known or suspected sensitivity to any substance that is contained in the study drug formulation.
Subject is a relative of an investigational site staff member.
Subject is, in the opinion of the investigator, unsuitable in any other way to participate in this study.

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

Atlanta Center for Medical Research
Atlanta, Georgia, 30308
MCB Clinical Research Centers, LLC
Colorado Springs, Colorado, 80910
iResearch Atlanta, LLC
Decatur, Georgia, 30030
Palm Springs Research Institute
Hialeah, Florida, 33012
Woodland International Research Group
Little Rock, Arkansas, 72211
Louisiana Research Associates, Inc
New Orleans, Louisiana, 70114
IPS Research Company
Oklahoma City, Oklahoma, 73103
Cutting Edge Research Group
Oklahoma City, Oklahoma, 73116
Aspen Clinical Research
Orem, Utah, 84058
Wake Research
Raleigh, North Carolina, 27612
Clinical Trials of Texas, Inc. (CTT)
San Antonio, Texas, 78229
Road Runner Research
San Antonio, Texas, 78258

Other trials in United States

About this study

Official title: A Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Evaluation of Single Oral Doses of SEP-225289 in Subjects 6 to 17 Years of Age With Attention Deficit Hyperactivity Disorder

Pediatric PK study of SEP-225289 (Dasotraline)

Read the detailed description

To characterize the pharmacokinetics (PK) and assess safety and tolerability of a range of single oral doses of SEP-225289 in subjects 6 to 17 years old with ADHD

Conditions: Pediatric Attention Deficit Hyperactivity Disorder
Being tested: Dasotraline 1 mg, 2 mg, 4 mg, 8 mg, 12 mg, 16 mg, 20 mg, 24 mg, 28 mg, 32 mg once daily

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dasotraline 1 mg, 2 mg, 4 mg, 8 mg, 12 mg, 16 mg, 20 mg, 24 mg, 28 mg, 32 mg once dailyDrug
Dasotraline 1 mg, 2 mg, 4 mg, 8 mg, 12 mg, 16 mg, 20 mg, 24 mg, 28 mg, 32 mg once daily. The planned dose for the first cohort is 1mg. There will be no more than a 2-fold increase in dose increase in dose between consecutive dose cohorts up to 8 mg, and dose cohorts beyond the 8 mg level will increment no more than 4mg. The maximum dose will not exceed 32mg." The language should precede the text that is currently there

Study groups in NCT02195167
Study group	Role	What they receive
Dasotraline	Experimental	Dasotraline 1 mg, 2 mg, 4 mg, 8 mg, 12 mg, 16 mg, 20 mg, 24 mg, 28 mg, 32 mg once daily. The planned dose for the first cohort is 1mg. There will be no more than a 2-fold increase in dose increase in dose between consecutive dose cohorts up to 8 mg, and dose cohorts beyond the 8 mg level will increment no more than 4mg. The maximum dose will not exceed 32mg." The language should precede the text that is currently there Receives: Drug: Dasotraline 1 mg, 2 mg, 4 mg, 8 mg, 12 mg, 16 mg, 20 mg, 24 mg, 28 mg, 32 mg once daily

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum concentration (Cmax), tmax, t1/2, area under the concentration from time zero to infinite time (AUC0-inf), and AUC0-last.
Measured: 0-51 Days
Incidence of AEs, SAEs, and discontinuation due to AE
Measured: 0-51 Days
Clinical Global Impressions-Severity of Illness (CGI-S) score and Columbia Suicide Severity Rating Scale (C-SSRS) evaluation.
Measured: 0-51 Days
Absolute values-changes from baseline in clinical laboratory tests, vital signs, orthostatic changes, and 12-lead electrocardiograms (ECGs).
Measured: 0-51 Days

Secondary outcomes (2)

Apparent clearance (CL/F), apparent volume of distribution (Vz/F), and terminal elimination rate constant (λz).
Measured: 0-51 Days
Time to maximal reduction of plasma DHPG, percent maximal reduction of plasma DHPG concentration relative to baseline, minimal observed plasma DHPG concentration postdose, and time to minimal observed plasma DHPG concentration postdose.
Measured: 0-51 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2014Mar 2015

First posted21 Jul 2014 (estimated)
Study startJul 2014
Primary completionMar 2015
Study completionMar 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pediatric 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 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 105 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02195167
Sponsor's protocol ID: SEP360-105
Status last verified: Mar 2015
First submitted: 17 Jul 2014
Last updated: 31 Mar 2015
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pediatric Attention Deficit Hyperactivity Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Evaluation of Single Oral Doses of SEP-225289 in Subjects 6 to 17 Years of Age With Attention Deficit Hyperactivity Disorder
ClinicalTrials.gov ID: NCT02195167
Acronym / sponsor ID: SEP360-105
Conditions: Pediatric Attention Deficit Hyperactivity Disorder
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 105 participants (actual)
Lead sponsor: Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
Study start: Jul 2014
Primary completion: Mar 2015 (actual)
Study completion: Mar 2015 (actual)
First posted: 21 Jul 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Pediatric PK study of SEP-225289 (Dasotraline)

Detailed description

To characterize the pharmacokinetics (PK) and assess safety and tolerability of a range of single oral doses of SEP-225289 in subjects 6 to 17 years old with ADHD

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: Dasotraline 1 mg, 2 mg, 4 mg, 8 mg, 12 mg, 16 mg, 20 mg, 24 mg, 28 mg, 32 mg once dailyDasotraline 1 mg, 2 mg, 4 mg, 8 mg, 12 mg, 16 mg, 20 mg, 24 mg, 28 mg, 32 mg once daily. The planned dose for the first cohort is 1mg. There will be no more than a 2-fold increase in dose increase in dose between consecutive dose cohorts up to 8 mg, and dose cohorts beyond the 8 mg level will increment no more than 4mg. The maximum dose will not exceed 32mg." The language should precede the text that is currently there

Who may qualify

Ages: 6 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (10 listed)

Subject, male or female, must be between 6 and 17 years of age, inclusive, at the time of consent. Note: Subjects who are 17 years of age at time of consent must not have a birthday within the following 4 weeks in order to be eligible for the study.
Subject meets Diagnostic and Statistical Manual of Mental Disorders Fourth Edition; Text Revision (DSM-IV-TR) criteria for a primary diagnosis of ADHD (inattentive, hyperactive, or combined subtype) established by a comprehensive psychiatric evaluation that reviews DSM-IV-TR criteria prior to Screening. Diagnosis is confirmed at Screening using Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
Subject's parents/legal guardians must give written informed consent, including privacy authorization, prior to study participation. The subject will complete an informed assent prior to study participation. Note: Informed consent will be obtained from both parents unless one parent is deceased, unknown, incompetent, or when one parent has legal responsibility for the care and custody of the child.
Subject and the subject's parents/legal guardians must be judged by the investigator to be willing and able to comply with the study procedures and visit schedules, including venipuncture, overnight stay (recommended for parent/legal guardian to remain overnight with the subject), and follow-up visits.
Subject, if female, must not be pregnant or breastfeeding, and if ≥ 8 years of age must have a negative serum pregnancy test at screening.

Key exclusion criteria (23 listed)

Subject or parents/legal guardians have daily commitments during the study that would interfere with attending study visits.
Subject has any clinically significant unstable medical abnormality, chronic disease, or a history of a clinically significant abnormality of the cardiovascular,gastrointestinal, respiratory, hepatic, or renal systems, or a disorder or history of a condition (eg, malabsorption, gastrointestinal surgery) that may interfere with drug absorption, distribution, metabolism, or excretion.
Subject has a history or presence of abnormal ECGs, which in the investigator's opinion is clinically significant. Screening ECGs will be centrally over-read, and eligibility will be determined based on the over-read report.
Subject has a documented history of Bipolar I or II Disorder, major depression, conduct disorder, oppositional defiant disorder, generalized anxiety disorder (other than obsessive-compulsive disorder) or any history of psychosis, that has been the primary focus of treatment at any time during the 12 months prior to screening.
Subject has organic brain disease, for example, traumatic brain injury residua, or a history of febrile seizures. Subjects taking anticonvulsants for seizure control currently or within the past 2 years are not eligible for study participation.

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
Dasotraline 1 mg, 2 mg, 4 mg, 8 mg, 12 mg, 16 mg, 20 mg, 24 mg, 28 mg, 32 mg once dailyDasotraline 1 mg, 2 mg, 4 mg, 8 mg, 12 mg, 16 mg, 20 mg, 24 mg, 28 mg, 32 mg once daily. The planned dose for the first cohort is 1mg. There will be no more than a 2-fold increase in dose increase in dose between consecutive dose cohorts up to 8 mg, and dose cohorts beyond the 8 mg level will increment no more than 4mg. The maximum dose will not exceed 32mg." The language should precede the text that is currently there	Drug	Dasotraline

Primary outcome

Maximum concentration (Cmax), tmax, t1/2, area under the concentration from time zero to infinite time (AUC0-inf), and AUC0-last.
Time frame: 0-51 Days
Incidence of AEs, SAEs, and discontinuation due to AE
Time frame: 0-51 Days
Clinical Global Impressions-Severity of Illness (CGI-S) score and Columbia Suicide Severity Rating Scale (C-SSRS) evaluation.
Time frame: 0-51 Days
Absolute values-changes from baseline in clinical laboratory tests, vital signs, orthostatic changes, and 12-lead electrocardiograms (ECGs).
Time frame: 0-51 Days

2 secondary outcomes

Apparent clearance (CL/F), apparent volume of distribution (Vz/F), and terminal elimination rate constant (λz).
Time frame: 0-51 Days
Time to maximal reduction of plasma DHPG, percent maximal reduction of plasma DHPG concentration relative to baseline, minimal observed plasma DHPG concentration postdose, and time to minimal observed plasma DHPG concentration postdose.
Time frame: 0-51 Days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.

Related trials for Pediatric Attention Deficit Hyperactivity Disorder

RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
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Recruiting
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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, MD study director

Sumitomo Pharma America, Inc.

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 10 inclusion and 23 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 31 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Maximum concentration (Cmax), tmax, t1/2, area under the concentration from time zero to infinite time (AUC0-inf), and AUC0-last. (time frame: 0-51 Days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02195167.

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 31 Mar 2015.