Dasotraline Pediatric Extension Study

• Sponsor: Sunovion (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02457819
• Collaborator: (none)
• Enrollment: 237
• Locations: 36
• Arm: 1
• Actual Duration (Months): 19.2
• Patients Per Site: 6.6
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This is an open label 26 week extension study for subjects who completed SEP360-202.

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Hyperactivity Disorder	Drug: Dasotraline	Phase 3

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

• Study Type: Interventional
• Actual Enrollment: 237 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Masking Description: Open label
• Primary Purpose: Treatment
• Official Title: An Open-label, Flexibly-dosed, 26-Week Extension Safety Study of Dasotraline in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
• Actual Study Start Date: Jun 30, 2015
• Actual Primary Completion Date: Feb 2, 2017
• Actual Study Completion Date: Feb 2, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dasotraline Dasotraline 2, 4, 6 mg	Drug: Dasotraline; Dasotraline 2 mg, 4 mg, 6 mg, once daily, flexibly dosed

Outcome Measures

Primary Outcome Measures

1. The Incidence of Overall Adverse Events, AEs , Serious Adverse Envents,(or SAEs), and AEs (or SAEs) Leading to Discontinuation [26 Weeks]

   Overall adverse events, AEs , serious adverse envents,(or SAEs), and AEs (or SAEs) leading to discontinuation.

Secondary Outcome Measures

1. Change From Baseline, in Attention Deficit Hyperactivity Disorder Rating Scale, Version IV, Home Version, (ADHD RS IV HV) Total Score. [26 Weeks]

   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).

2. Change From Baseline, in Clinical Global Impression-Severity of Illness (CGI S) Score. [26 weeks]

   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.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• 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);

-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.

Exclusion Criteria:

• -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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Harmonex Neuroscience Research, Inc	Dothan	Alabama	United States	36303
2	ProScience Research Group	Culver City	California	United States	90230
3	Elite Clinical Trials, Inc.	Wildomar	California	United States	92595
4	MCB Clinical Research Centers, LLC	Colorado Springs	Colorado	United States	80910
5	Sarkis Clinical Trials	Gainesville	Florida	United States	32607
6	Indago Research Health Center, Inc.	Hialeah	Florida	United States	33012
7	Clinical Neuroscience Solutions, Inc	Jacksonville	Florida	United States	32256
8	Florida Clinical Research Center, LLC	Maitland	Florida	United States	32751
9	Clinical Neuroscience Solutions, Inc.	Orlando	Florida	United States	32801
10	Miami Research Associates, LLC	South Miami	Florida	United States	33143
11	Atlanta Center for Medical Research	Atlanta	Georgia	United States	30331
12	iResearch Atlanta, LLC	Decatur	Georgia	United States	30030
13	Capstone Clinical Research	Libertyville	Illinois	United States	60418
14	Baber Research Group, Inc.	Naperville	Illinois	United States	630-896-3530
15	Goldpoint Clinical Research, LLC.	Indianapolis	Indiana	United States	46260
16	Pedia Research,LLC	Newburgh	Indiana	United States	47630
17	Psychiatric Associates	Overland Park	Kansas	United States	66211
18	Pedia Research,LLC	Owensboro	Kentucky	United States	42301
19	Neurobehavioral Medicine Group, Clinical Trials Division	Bloomfield Hills	Michigan	United States	48302
20	Clinical Trials group at the Rochester Center for Behavioral Medicine	Rochester Hills	Michigan	United States	48307
21	St. Charles Psychiatric Associates - Midwest Research Group	Saint Charles	Missouri	United States	63304
22	Center for Psychiatry and Behavioral Medicine, Inc.	Las Vegas	Nevada	United States	89128
23	Pharmaceutical Research Associates, Inc.	Marlton	New Jersey	United States	08053
24	Richarmond Behavioral Associates	Staten Island	New York	United States	10312
25	University of Cincinnati/Department of Psychiatry and Behavioral Neuroscience	Cincinnati	Ohio	United States	45219
26	University Hospitals Case Medical Center	Cleveland	Ohio	United States	44106
27	IPS Research Company	Oklahoma City	Oklahoma	United States	73103
28	Cutting Edge Research Group	Oklahoma City	Oklahoma	United States	73116
29	Cyn3rgy Research	Gresham	Oregon	United States	97030
30	Coastal Carolina Research Center	Mount Pleasant	South Carolina	United States	29464
31	BioBehavioral Research of Austin P.C.	Austin	Texas	United States	78759
32	Bayou City Research, Ltd.	Houston	Texas	United States	77007
33	Houston Clinical Trials, LLC	Houston	Texas	United States	77098
34	Clinical Trials of Texas, Inc.	San Antonio	Texas	United States	78229
35	Road Runner Research, Ltd.	San Antonio	Texas	United States	78258
36	Family Psychiatry of the Woodlands	The Woodlands	Texas	United States	77381

Sponsors and Collaborators

• Sunovion

Investigators

• Study Director: Dasotraline Medical Director, Sunovion

Study Documents (Full-Text)

• Study Protocol - Jan 20, 2016
• Statistical Analysis Plan - Mar 9, 2017

More Information

Publications

None provided.

• Responsible Party: Sunovion
• ClinicalTrials.gov Identifier: NCT02457819
• Other Study ID Numbers: SEP360-310
• First Posted: May 29, 2015
• Last Update Posted: Jan 28, 2020
• Last Verified: Jan 1, 2020

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

Study Results

Participant Flow

Arm/Group Title	Dasotraline
Arm/Group Description	Dasotraline 2, 4, 6 mg, flexibly dosed
Period Title: Overall Study
STARTED	237
Safety Population	236
COMPLETED	138
NOT COMPLETED	99

Baseline Characteristics

Arm/Group Title	Dasotraline
Arm/Group Description	Dasotraline 2, 4, 6 mg, flexibly dosed
Overall Participants	236
Age (Count of Participants)
<=18 years	236 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	76 32.2%
Male	160 67.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	37 15.7%
Not Hispanic or Latino	199 84.3%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.4%
Asian	2 0.8%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	71 30.1%
White	146 61.9%
More than one race	7 3%
Unknown or Not Reported	9 3.8%
Region of Enrollment (participants) [Number]
United States	236 100%

Outcome Measures

1. Primary Outcome

Title	The Incidence of Overall Adverse Events, AEs , Serious Adverse Envents,(or SAEs), and AEs (or SAEs) Leading to Discontinuation
Description	Overall adverse events, AEs , serious adverse envents,(or SAEs), and AEs (or SAEs) leading to discontinuation.
Time Frame	26 Weeks

Outcome Measure Data

Analysis Population Description

safety population

Arm/Group Title	Dasotraline
Arm/Group Description	Dasotraline 2, 4, 6 mg, flexibly dosed
Measure Participants	236
Subjects with any TEAE	144
Subjects with any TEAE leading to discontinuation	30
Subjects with any serious TEAE	3
Subjects with any serious treatment-related TEAE	1
treatment-related TEAE leading to discontinuation	1

2. Secondary Outcome

Title	Change From Baseline, in Attention Deficit Hyperactivity Disorder Rating Scale, Version IV, Home Version, (ADHD RS IV HV) Total Score.
Description	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).
Time Frame	26 Weeks

Outcome Measure Data

Analysis Population Description

safety population

Arm/Group Title	Dasotraline
Arm/Group Description	Dasotraline 2, 4, 6 mg, flexibly dosed
Measure Participants	138
Mean (Standard Deviation) [units on a scale]	-7.1 (10.19)

3. Secondary Outcome

Title	Change From Baseline, in Clinical Global Impression-Severity of Illness (CGI S) Score.
Description	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.
Time Frame	26 weeks

Outcome Measure Data

Analysis Population Description

safety population

Arm/Group Title	Dasotraline
Arm/Group Description	Dasotraline 2, 4, 6 mg, flexibly dosed
Measure Participants	139
Mean (Standard Deviation) [units on a scale]	-0.6 (1.11)

Adverse Events

Time Frame	26 weeks
Arm/Group Title	Dasotraline
Arm/Group Description	Dasotraline 2, 4, 6 mg, flexibly dosed
All Cause Mortality
	Dasotraline
	Affected / at Risk (%)	# Events
Total	0/236 (0%)
Serious Adverse Events
	Dasotraline
	Affected / at Risk (%)	# Events
Total	3/236 (1.3%)
Infections and infestations
Pyelonephritis	1/236 (0.4%)	1
Nervous system disorders
Psychomotor hyperactivity	1/236 (0.4%)	1
Product Issues
Panic attack	1/236 (0.4%)	1
Psychiatric disorders
Anxiety	1/236 (0.4%)	1
Substance-induced psychotic disorder	1/236 (0.4%)	1
Suicidal ideatin	1/236 (0.4%)	1
Skin and subcutaneous tissue disorders
Rash macular	1/236 (0.4%)	1
Other (Not Including Serious) Adverse Events
	Dasotraline
	Affected / at Risk (%)	# Events
Total	94/236 (39.8%)
Investigations
Weight decreased	29/236 (12.3%)	30
Metabolism and nutrition disorders
Decreased apppetite	49/236 (20.8%)	56
Nervous system disorders
Headache	26/236 (11%)	31
Anxiety	13/236 (5.5%)	15
Initial insomnia	26/236 (11%)	30
Irritability	20/236 (8.5%)	22

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.