Dasotraline Pediatric ADHD Study

• Sponsor: Sunovion (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02428088
• Collaborator: (none)
• Enrollment: 330
• Locations: 43
• Arms: 3
• Duration (Months): 15
• Patients Per Site: 7.7
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

This is a 6 week efficacy and safety study of Dasotraline in subjects 6 to 12 years old with ADHD.

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Hyperactivity Disorder	Drug: Dasotraline; Drug: Dasotraline; Drug: Placebo Comparator	Phase 2/Phase 3

Detailed Description

This is a randomized, double blind, multicenter, placebo-controlled, parallel group, outpatient study evaluating the efficacy and safety of dasotraline in subjects 6 to 12 years of age with ADHD using 2 doses of dasotraline (2 mg/day and 4 mg/day) versus placebo over a 6 week treatment period. The study will consist of screening, treatment, and end of study visits.

Study Design

• Study Type: Interventional
• Actual Enrollment: 330 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A 6-week, Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-group Efficacy and Safety Study of Dasotraline Versus Placebo in Subjects 6 to 12 Years of Age With Attention Deficit Hyperactivity Disorder (ADHD)
• Study Start Date: Apr 1, 2015
• Actual Primary Completion Date: Jul 1, 2016
• Actual Study Completion Date: Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dasotraline 2 mg Dasotraline 2 mg	Drug: Dasotraline; Dasotraline 2 mg once daily; Other Names: SEP-225289
Experimental: Dasotraline 4 mg Dasotraline 4 mg	Drug: Dasotraline; Dasotraline 4 mg once daily; Other Names: SEP-225289
Placebo Comparator: Placebo Placebo	Drug: Placebo Comparator; Placebo once daily

Outcome Measures

Primary Outcome Measures

1. Change from baseline at Week 6 in ADHD symptoms as measured by ADHD RS IV HV. [Baseline, 6 Weeks]

Secondary Outcome Measures

1. Change from baseline in ADHD symptoms as measured by in ADHD RS IV HV at Weeks 1, 2, 3, 4, and 5. [Baseline, Weeks 1,2,3,4,5]

2. Change from baseline in the inattentiveness and hyperactivity subscales of the ADHD RS IV HV at Weeks 1, 2, 3, 4, 5, and 6. [Baseline, Weeks 1,2,3,4,5,6]

3. The percentage of responders at Weeks 1, 2, 3, 4, 5, and 6. A responder is defined as a subject with a ≥ 30% improvement in ADHD symptoms compared with baseline as measured by the ADHD RS IV HV. [Baseline, Weeks 1,2,3,4,5,6]

4. Change from baseline in CGI-S scale at Weeks 1, 2, 3, 4, 5, and 6. [Baseline, Weeks 1,2,3,4,5,6]

5. Change from baseline in Conners 3 P total score and subscale scores (Oppositional, Cognitive problems, Hyperactivity, and ADHD Index) at Weeks 1, 2, 3, 4, 5, and 6. [Baseline, Weeks 1,2,3,4,5,6]

6. Change from baseline in Conners 3 T total score at Weeks 3 and 6. [Baseline, Weeks 3, 6]

7. Change from baseline in WPREMB R total score and subscores at Weeks 1, 2, 3, 4, 5, and 6. [Baseline, Weeks 1,2,3,4,5,6]

8. The incidence of overall AEs, serious AEs (SAEs), and AEs (or SAEs) leading to discontinuations. [Baseline, 6 Weeks]

9. Absolute values and change from baseline in clinical laboratory evaluations (serum chemistry). [Baseline, 6 Weeks]

10. Absolute values and change from baseline in clinical laboratory evaluations (hematology). [Baseline, 6 Weeks]

11. Absolute values and change from baseline in clinical laboratory evaluations (lipid panel). [Baseline, 6 Weeks]

12. Absolute values and change from baseline in clinical laboratory evaluations (thyroid panel). [Baseline, 6 Weeks]

13. Absolute values and change from baseline in clinical laboratory evaluations (sex hormones). [Baseline, 6 Weeks]

14. Absolute values and change from baseline in clinical laboratory evaluations (urinalysis). [Baseline, 6 Weeks]

15. Absolute values and changes from baseline in 12 lead ECGs. [Baseline, 6 Weeks]

16. Absolute values and changes from baseline in vital signs. [Baseline, 6 Weeks]

17. Absolute values and changes from baseline in body weights. [Baseline, 6 Weeks]

18. Change from baseline in CSHQ total score and 8 subscale scores (bedtime resistance, sleep onset delay, sleep duration, sleep anxiety, night wakings, parasomnias, sleep disordered breathing, and daytime sleepiness) at Weeks 1, 2, 3, 4, 5, and 6. [Baseline, Weeks 1,2,3,4,5,6]

19. Change from baseline in Tanner staging at Week 6. [6 Weeks]

20. Frequency of suicidal ideation and suicidal behavior as assessed by the C SSRS. [6 Weeks]

21. Severity of suicidal ideation and suicidal behavior as assessed by the C SSRS. [6 Weeks]

22. Dasotraline plasma concentration for PK at Weeks 2, 4, and 6. [Baseline, Weeks 2,4,6]

23. Change from baseline in DHPG concentration at Weeks 2, 4, and 6. [Baseline, Weeks 2,4,6]

24. Change from baseline in NE concentration at Weeks 2, 4, and 6. [Baseline, Weeks 2,4,6]

25. Change from baseline in WFIRS P total score and 6 domain scores (family, learning and school, life skills, child's self-concept, social activities and risky activities) at Week 3 and 6. [Baseline, Weeks 3,6]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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 the subject's parent/legal guardian must be judged by the investigator to be willing and able to comply with the study procedures and visit schedules.

• Subject, male or female, must be between 6 and 12 years of age, inclusive, at the time of consent/assent and at Baseline.

• Subject meets Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM

1. criteria for a primary diagnosis of ADHD (inattentive, hyperactive, or combined presentation) at screening established by a comprehensive psychiatric evaluation that reviews DSM 5 criteria is confirmed using the K-SADS-PL at Screening.

• Subject has an ADHD RS IV HV score of ≥ 28.

• Subject has a CGI S score of ≥ 4.

• Subject, if female, must not be pregnant or breastfeeding, and if ≥ 8 years of age must have a negative pregnancy test.

• Female subject:

• must be unable to become pregnant (eg, premenarchal, surgically sterile, etc);

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 (see Appendix VII) 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 be using 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.

• 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, vital signs, 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 may be included only if the investigator determines the deviations to be not clinically relevant.

• Subject weighs at least 21 kg and is within 3rd to 97th percentile for gender specific body-mass-index (BMI)-for-age from the World Health Organization (WHO) growth charts (see Appendices II and IX).

• Subject's parent/legal guardian must report a history of the subject being able to swallow capsules.

• Subject and subject's parents/legal guardians 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.

Exclusion Criteria:

• Subject or parent/legal guardian has commitments during the study that would interfere with attending study visits.

• Subject currently has a diagnosis of asthma that has required daily treatment with bronchodilators or nebulizer treatments in the 30 days prior to screening and/or who may require daily treatments with these agents over the course of the trial. Intermittent use of bronchodilators is not exclusionary. Subjects who have a history of requiring persistent asthma treatment should be discussed wit the medical monitor prior to enrolment.

• 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. Note: Active medical conditions that are minor or well-controlled are not exclusionary if they do not affect risk to the subject or the study results. In cases in which the impact of the condition upon risk to the subject or study results is unclear, the Medical Monitor should be consulted. Any subject with a known cardiovascular disease or condition (even if controlled) must be discussed with the Medical Monitor during screening.

• Subject has a history or presence of abnormal ECGs, which in the investigator's opinion is clinically significant. Screening site ECGs will be centrally over-read, and eligibility will be determined by the investigator based on the results of the over-read report.

• Subject has any documented diagnosis of Bipolar I or II Disorder, major depressive disorder, conduct disorder, obsessive-compulsive disorder, disruptive mood dysregulation disorder (DMDD), intellectual disability, any history of psychosis, autism spectrum disorder, Tourette's Syndrome, confirmed genetic disorder with cognitive and/or behavioral disturbances. Note: Subjects with oppositional defiant disorder (ODD) are permitted to enroll in the study as long as ODD is not the primary focus of treatment.

• Subject has generalized anxiety disorder that has been the primary focus of treatment at any time during the 12 months prior to screening or that required pharmacotherapy any time in the 6 months prior to screening.

• Subject has failed 2 adequate courses of stimulant or non-stimulant treatment for ADHD, as judged by the investigator.

• Subject has evidence of any chronic disease of the central nervous system (CNS) such as tumors, inflammation, seizure disorder, vascular disorder, potential CNS related disorders that might occur in childhood (eg, Duchenne Muscular dystrophy, myasthenia gravis, or other neurologic or serious neuromuscular disorders), or history of persistent neurological symptoms attributable to serious head injury. Past history of febrile seizure, drug-induced seizure, or alcohol withdrawal seizure is exclusionary. Subject taking anticonvulsants for seizure control currently or within the past 2 years is not eligible for study participation.

• Subject has uncontrolled thyroid disorder indicated by free T4, free T3, or thyroid stimulating hormone (TSH) outside the limit of normal for the reference laboratory.

• 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 Lifetime/Recent assessment at screening.

• Subject has any history of attempted suicide, in the opinion of the investigator.

• 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 or has a history of allergic reaction or has a known or suspected sensitivity to any substance that is contained in the study drug formulations.

• Subject has history of intolerance to stimulants.

• Subject has taken any antipsychotic medication within 8 weeks prior to screening.

• Subject taking any medication, including health food supplements with purported psychotropic activity (for example, St. John's Wort), must have a minimum washout of 7 days prior to Day 1.

• Subject taking any antidepressant medication (eg, bupropion, selective serotonin reuptake inhibitor [SSRI]/ serotonin norepinephrine reuptake inhibitor [SNRI], monoamine oxidase [MAO] inhibitor, tricyclic, etc) must have a minimum washout of 7 days prior to Day 1.

• Subject is currently undergoing Cognitive Behavioral Therapy (CBT) for the treatment of ADHD, has initiated behavioral therapy (including school based interventions) less than 1 month prior to screening, or is receiving behavioral therapy and in the opinion of the investigator will not be able to follow a stable routine for the duration of the study.

• Subject or subject's family anticipates a move outside the geographic range of 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 melanomatous skin cancer.

• Subject has history of positive test for Hepatitis B surface antigen or Hepatitis C antibody and has liver function test results at screening above the upper limit of normal for the reference laboratory.

• Subject is known to have tested positive for human immunodeficiency virus (HIV).

• Subject has participated in any investigational study within 90 days prior to screening or is currently participating in another clinical trial.

• Subject has a history of substance or alcohol use disorder (excluding caffeine) within the 12 months prior to screening, as defined by the DSM 5 criteria, or is currently using tobacco or other nicotine-containing products, or has a positive urine drug screen (UDS) or breath alcohol test at screening. Note: Subjects with a positive UDS may be allowed to continue in the study, provided that the investigator determines that the positive test is as a result of taking prescription medicine(s) as prescribed.

• Subject requires treatment with any disallowed medications during the study.

• Subject has experienced significant blood loss within 60 days prior to screening.

• Subject has previously been enrolled in a clinical trial of dasotraline (SEP 225289).

• Subject's parent/legal guardian is an investigational site staff member or the 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Harmonex Neuroscience Research	Dothan	Alabama	United States	36303
2	Synergy Research	National City	California	United States	91950
3	California Clinical Trials	Paramount	California	United States	90723
4	PCSD-Feighner Research	San Diego	California	United States	92108
5	Elite Clinical Trials, Inc.	Wildomar	California	United States	92595
6	MCB Clinical Research Centers, LLC	Colorado Springs	Colorado	United States	80910
7	Gulfcoast Clinical Research	Fort Myers	Florida	United States	33912
8	Sarkis Clinical Trials - Parent	Gainesville	Florida	United States	32607
9	Palm Springs Research Institute	Hialeah	Florida	United States	33012
10	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida	United States	32256
11	Florida Clinical Research Center, LLC	Maitland	Florida	United States	32751
12	Clinical Neuroscience Solutions	Orlando	Florida	United States	32806
13	Atlanta Center for Medical Research	Atlanta	Georgia	United States	30308
14	iResearch Atlanta, LLC	Decatur	Georgia	United States	30030
15	Capstone Clinical Research, Inc.	Libertyville	Illinois	United States	60048
16	Baber Research Group	Naperville	Illinois	United States	60563
17	Goldpoint Clinical Research	Indianapolis	Indiana	United States	46260
18	Pedia Research,LLC	Newburgh	Indiana	United States	47630
19	Psychiatric Associates	Overland Park	Kansas	United States	66211
20	Pedia Research,LLC	Owensboro	Kentucky	United States	42301
21	Hugo W. Moser Research Institute at Kennedy Krieger	Baltimore	Maryland	United States	21205
22	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
23	Neurobehaviorial Medicine Group, PLLC	Bloomfield Hills	Michigan	United States	48302
24	Rochester Center for Behavioral Medicine	Rochester Hills	Michigan	United States	48307
25	Midwest Research Group	Saint Charles	Missouri	United States	63304
26	Center for Psychiatry and Behavioral Medicine, Inc.	Las Vegas	Nevada	United States	89128
27	Pharmaceutical Research Associates, Inc.	Marlton	New Jersey	United States	08053
28	Richmond Behavioral Associates	Staten Island	New York	United States	10312
29	Duke University Medical Center - Duke Child and Family Study Center	Durham	North Carolina	United States	27705
30	University of Cincinnati/Department of Psychiatry and Behavioral Neuroscience	Cincinnati	Ohio	United States	45219
31	University Hospitals Cleveland Medical Center	Cleveland	Ohio	United States	44106
32	North Star Medical Research, LLC	Middleburg Heights	Ohio	United States	44130
33	IPS Research Company	Oklahoma City	Oklahoma	United States	73103
34	Cutting Edge Research Group	Oklahoma City	Oklahoma	United States	73116
35	Cyn3rgy Research	Gresham	Oregon	United States	97030
36	BioBehavioral Research of Austin P.C.	Austin	Texas	United States	78759
37	Pillar Clinical Research, LLC	Dallas	Texas	United States	75228
38	Bayou City Research Corporation	Houston	Texas	United States	77007
39	Houston Clinical Trials, LLC	Houston	Texas	United States	77098
40	Clinical Trials of Texas, Inc.	San Antonio	Texas	United States	78229
41	Road Runner Research	San Antonio	Texas	United States	78258
42	Family Psychiatry of The Woodlands, P.A.	The Woodlands	Texas	United States	77381
43	Aspen Clinical Research	Orem	Utah	United States	84058

Sponsors and Collaborators

• Sunovion

Investigators

• Study Director: Dasotraline Medical Director, MD, Sunovion

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sunovion
• ClinicalTrials.gov Identifier: NCT02428088
• Other Study ID Numbers: SEP360-202
• First Posted: Apr 28, 2015
• Last Update Posted: Mar 18, 2021
• Last Verified: Mar 1, 2021

• Additional relevant MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity

Study Results

No Results Posted as of Mar 18, 2021