Dasotraline Adult ADHD Study

Sponsor

Sunovion (Industry)

Overall Status

Completed

CT.gov ID

NCT02276209

Collaborator

(none)

636

Enrollment

Locations

Arms

Duration (Months)

10.8

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a randomized, double blind, multicenter, parallel group, outpatient study evaluating the efficacy and safety of dasotraline in adults with ADHD.

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

Detailed Description

This is a randomized, double blind, multicenter, parallel group, outpatient study evaluating the efficacy and safety of dasotraline in adults with ADHD using 2 doses of dasotraline (4 mg/day or 6 mg/day) versus placebo over an 8 week treatment period (8 weeks of active treatment followed by a 2-week withdrawal phase).

Study Design

Study Type:

Interventional

Actual Enrollment :

636 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double Blind, Multicenter, Placebo Controlled, Parallel Group, Efficacy and Safety Study of 2 Doses of Dasotraline in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

Study Start Date :

Dec 1, 2014

Actual Primary Completion Date :

Sep 1, 2016

Actual Study Completion Date :

Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dasotraline 4 mg Dasotraline 4 mg once daily	Drug: Dasotraline Dasotraline 4 mg once daily
Experimental: Dasotraline 6 mg Dasotraline 6 mg once daily	Drug: Dasotraline Dasotraline 6 mg once daily
Placebo Comparator: Placebo Placebo once daily	Other: Placebo Placebo once daily

Arm

Intervention/Treatment

Experimental: Dasotraline 4 mg

Dasotraline 4 mg once daily

Drug: Dasotraline

Dasotraline 4 mg once daily

Experimental: Dasotraline 6 mg

Dasotraline 6 mg once daily

Drug: Dasotraline

Dasotraline 6 mg once daily

Placebo Comparator: Placebo

Placebo once daily

Other: Placebo

Placebo once daily

Outcome Measures

Primary Outcome Measures

Change from baseline at Week 8 in ADHD symptoms measured by the ADHD Rating Scale Version IV (ADHD RS IV) with adult prompts total score. [8 Weeks]

Secondary Outcome Measures

Change from baseline in ADHD symptoms measured with the ADHD Rating Scale Version IV (ADHD RS IV) with adult prompts total score at Weeks 1, 2, 4, and 6. [8 Weeks]
Change from baseline in the inattentiveness and hyperactivity-impulsivity subscale scores of the ADHD Rating Scale Version IV (ADHD RS IV) with adult prompts at Weeks 1, 2, 4, 6, and 8. [8 Weeks]
Change from baseline in Clinical Global Impression - Severity scale (CGI S) scale at Weeks 1, 2, 4, 6, and 8. [8 Weeks]
Change from baseline in Sheehan Depression Scale (SDS) total score at Weeks 4 and 8. [8 Weeks]
Change from baseline in Sheehan Depression Scale (SDS) domain scores: work/school, family life, social life at Weeks 4 and 8. [8 Weeks]
Change from baseline in Behavior Rating Inventory of Executive Function®-Adult Version (BRIEF A) Global Executive Composite score and Behavioral Regulation Index (BRI) and Metacognition Index (MI) at Weeks 4 and 8. [8 Weeks]
Change from baseline in ADHD Impact Module - Adult AIM A in global domain scores at Weeks 4 and 8. [8 Weeks]
Time sensitive ADHD Symptom Scale (TASS) total score and subscale scores (Inattention and Hyperactive impulsive) at Weeks 3, 5, and 7. [8 Weeks]
Change from baseline in Adult ADHD Self Report Scale (Version 1.1) (ASRS) total score and subscale scores (inattention, hyperactivity-impulsivity, executive function, emotional control, and impulsivity) at each week. [8 Weeks]
Adult ADHD Medication Smoothness of Effect Scale (AMSES) score at Weeks 2, 4, 6, and 8. [8 Weeks]
Change from baseline in Pittsburgh Sleep Quality Index (PSQI) global score and 7 component scores at Weeks 2, 4, and 8. [8 Weeks]
The incidence of overall AEs, serious AEs (SAEs), and AEs (or SAEs) leading to discontinuations. [8 Weeks]
Clinical laboratory evaluations (serum chemistry). [8 Weeks]
Clinical laboratory evaluations ( lipid panel). [8 Weeks]
Clinical laboratory evaluations (thyroid function panel). [8 Weeks]
Clinical laboratory evaluations (hematology). [8 Weeks]
Clinical laboratory evaluations (urinalysis). [8 Weeks]
Clinical evaluations (vital signs). [8 Weeks]
Clinical evaluations (orthostatic effects). [8 Weeks]
Clinical evaluations (physical examinations). [8 Weeks]
Clinical evaluations (body weight). [8 Weeks]
Clinical evaluations (12 lead ECGs). [8 Weeks]
Frequency and severity of suicidal ideation and suicidal behavior as assessed by the C SSRS. [8 Weeks]
Drug Effects Questionnaire (DEQ) scores at Weeks 1, 2, 4, 6, and 8. [8 Weeks]
Symptoms of withdrawal by Physician Withdrawal Checklist (PWC) scores at Week 8, 9, and 10. [10 Weeks]
Symptoms of withdrawal by Study Medication Withdrawal Questionnaire (SMWQ) scores at Weeks 9 and 10. [10 Weeks]
Symptoms of withdrawal by Hamilton Anxiety Rating Scale (HAM A) scores at Weeks 8, 9, and 10. [10 Weeks]
Symptoms of withdrawal by Montgomery-Asberg Depression Rating Scale (MADRS) scores at Weeks 8, 9, and 10. [10 Weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subject is male or female, 18 to 55 years old, inclusive, at the time of informed consent.
Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM 5) criteria for a primary diagnosis of ADHD (inattentive, hyperactive, or combined subtype) established by a comprehensive psychiatric evaluation that reviews psychiatric criteria. Diagnosis is confirmed by Adult ADHD Clinical Diagnostic Scale (ACDS). Note: The diagnosis of ADHD and appropriateness of inclusion in the trial will be independently confirmed by external expert review. Experts will review diagnostic and other screening instruments for each subject and approval is required before a subject can be randomized. The Mini International Neuropsychiatric Interview (MINI) will be administered to confirm the absence of any other comorbid psychiatric disorders.
Subject has an ADHD RS IV with adult prompts total score of ≥ 26 at screening and at Baseline.
Subject has a CGI S score of ≥ 4 at screening and at Baseline.
Subject has a negative breath alcohol test and a negative urine drug screen (UDS) for any illicit drug at screening.
If the subject has a positive drug screen for ADHD medications (eg, amphetamine) at screening, the subject must have a negative repeat UDS at least 7 days before baseline.
Subject is male or a non pregnant, non lactating female.
Female subjects must have a negative serum pregnancy test at screening; females who are post menopausal (defined as at least 12 months of spontaneous amenorrhea) and those who have undergone hysterectomy or bilateral oophorectomy will be exempted from the pregnancy test.
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, as defined in Section 10.4, throughout the study period. Note: Continued use of an effective and medically acceptable form of birth control is recommended for 30 days after study completion.
Subject must have a stable living arrangement that allows for consistent participation for the full duration of the study.
Subject must be able to comply with study medication administration and adhere to protocol requirements.
Subject can read well enough to understand the informed consent form and other subject materials.
Subjects must complete a practice trial for the TASS assessment at one timepoint during Screening.

Exclusion Criteria:

Subject has a ≥ 25% improvement on the ADHD RS IV total score between screening and baseline.
Subject has a psychiatric disorder other than ADHD that has been the primary focus of treatment at any time during the 12 months before screening.
Subject has a past history of, or current presentation consistent with, bipolar disorder (including bipolar I and bipolar II), schizophrenia, schizoaffective disorder, or any other psychotic disorder; a personality disorder per DSM 5 criteria.
Subject has a history of drug dependence or Substance Related Disorder (excluding nicotine and caffeine) within the 12 months before screening, as defined by DSM 5 criteria.

-- Subject has Hamilton Anxiety Rating Scale (HAM A) total score ≥ 21 at screening and baseline.

Subject has PSQI total score ≥ 8 at screening or baseline or moderate to severe insomnia as determined by the Investigator.
Subject has a history of non-response (per clinician judgment) to two adequate treatment regimens of stimulant or non-stimulant treatment for ADHD.
Subject has a history of epilepsy, seizures (except childhood febrile seizures), unexplained syncope or other unexplained blackouts (except single incident), or head trauma with loss of consciousness lasting more than 5 minutes, or a history of clinically significant multiple head traumas without loss of consciousness.
Subject has an acute or chronic medical condition (other than ADHD) that in the opinion of the investigator could confound clinical assessments or interfere with the ability of the subject to participate in the study.
Subject is currently taking or has taken within 6 weeks prior to screening an antidepressent medication; antipsychotic medication; or lithium (any lithium preparation or formulation).
Subject is currently taking or has taken within the previous 6 months an anticonvulsant medication (eg, phenytoin, carbamazepine, lamotrigine, valproic acid); antipsychotic medication; or lithium (any lithium preparation or formulation).
Subject is currently taking an alpha 2 adrenergic receptor agonist (including clonidine and guanfacine).
Subject has a life-time history of a pattern of abuse or diversion of stimulants.
Subject has a body mass index (BMI) less than 18 or greater than 35 kg/m2 at screening or baseline.
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 assessment at screening (in the past month). Subjects who answer "yes" to this question must be referred to the Investigator for follow up evaluation.
Subject has attempted suicide within 2 years before the screening period.
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 (ULN) for the reference laboratory.
Subject is known to have tested positive for human immunodeficiency virus (HIV).
Subject has a clinically significant abnormality on screening evaluation including physical examination, vital signs, ECG, or laboratory tests that the Investigator considers to be inappropriate to allow participation in the study.
The subject's screening ECG shows a corrected QT interval using Fridericia's formula (QTcF) of ≥ 450 msec for male subjects or ≥ 470 msec for female subjects. Eligibility will be based on the core laboratory ECG interpretation report.
The subject's screening hematology results show an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value ≥ 2 times the ULN, or a blood urea nitrogen (BUN) value ≥ 1.5 times the ULN for the reference range.
Subject has a history of allergic reaction or has a known or suspected sensitivity to any substance that is contained in the study medication formulation.
Subject is currently participating or has participated in a clinical trial within the last 90 days or has participated in more than 2 clinical trials within the past year. This includes studies using marketed compounds or devices. Note: Subjects will be checked for multiple study enrollments by site staff.
Subject has been incarcerated in a prison within 12 months prior to Screening.
Subject has previously been randomized in a clinical trial of dasotraline.
Subject is an investigational site staff member or the relative of an investigational site staff member.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NoesisPharma,LLC	Phoenix	Arizona	United States	85032
2	Preferred Research Partners	Little Rock	Arkansas	United States	72211
3	Southern California Research LLC	Beverly Hills	California	United States	90210
4	Pharmacology Research Institute	Encino	California	United States	91316
5	Collaborative Neuroscience Network, LLC	Garden Grove	California	United States	92845
6	North County Clinical Research	Oceanside	California	United States	92056
7	University ot California, San Francisco	San Francisco	California	United States	94143
8	Elite Clinical Trials, Inc.	Wildomar	California	United States	92595
9	MCB Clinical Research Centers, LLC	Colorado Springs	Colorado	United States	80910
10	ConnecticutClinicalResearch	Cromwell	Connecticut	United States	06416
11	CNS Clinical Research Group	Coral Springs	Florida	United States	33067
12	Gulfcoast Clinical Research	Fort Myers	Florida	United States	33912
13	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida	United States	32256
14	Florida Clinical Research Center, LLC	Maitland	Florida	United States	32751
15	Miami Research Associates	Miami	Florida	United States	33143
16	Clinical Neuroscience Solutions, Inc.	Orlando	Florida	United States	32801
17	Meridien Research	Tampa	Florida	United States	33606
18	The Institute for Advanced Medical Research	Alpharetta	Georgia	United States	30005
19	Atlanta Center for Medical Research	Atlanta	Georgia	United States	30331
20	iResearch Atlanta, LLC	Decatur	Georgia	United States	30030
21	Northwest Behavioral Research Center	Roswell	Georgia	United States	30076
22	Carman Research	Smyrna	Georgia	United States	30080
23	Capstone Clinical Research, Inc.	Libertyville	Illinois	United States	60048
24	Alpine Clinic	Lafayette	Indiana	United States	47905
25	Lake Charles Clinical Trials	Lake Charles	Louisiana	United States	70629
26	Kennedy Krieger Institute	Baltimore	Maryland	United States	21205
27	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
28	Neurobehavioral Medicine Group	Bloomfield Hills	Michigan	United States	48302
29	Rochester Center for Behavioral Medicine	Rochester Hills	Michigan	United States	48307
30	Saint Charles Psychiatric Associates/Midwest Research Group	Saint Charles	Missouri	United States	63301
31	Midwest Research Group	Saint Charles	Missouri	United States	63304
32	Premier Psychiatric Research Institute, LLC	Lincoln	Nebraska	United States	68526
33	Center for Emotional Fitness	Cherry Hill	New Jersey	United States	08002
34	Village Clinical Research Inc.	New York	New York	United States	10003
35	NYU School of Medicine	New York	New York	United States	10016
36	Eastside Comprehensive Medical Center, LLC	New York	New York	United States	10021
37	Finger Lakes Clinical Research	Rochester	New York	United States	14618
38	Duke Child and Family Study Center	Durham	North Carolina	United States	27705
39	Triangle Neuropsychiatry	Durham	North Carolina	United States	27707
40	University of Cincinnati, Department of Psychiatry	Cincinnati	Ohio	United States	45219
41	IPS Research Company	Oklahoma City	Oklahoma	United States	73103
42	Paradigm Research Professionals	Oklahoma City	Oklahoma	United States	73118
43	SummitResearchNetwork	Portland	Oregon	United States	97210
44	Oregon Center for Clinical Investigations, Inc.	Portland	Oregon	United States	97214
45	Oregon Center for Clinical Investigations, Inc.	Salem	Oregon	United States	97301
46	Keystone Clinical Studies, LLC	Norristown	Pennsylvania	United States	19403
47	Medical University of SC (MUSC)	Charleston	South Carolina	United States	29425
48	Coastal Carolina Research Center	Mount Pleasant	South Carolina	United States	29464
49	FutureSearch Clinical Trials, LP	Austin	Texas	United States	78731
50	FutureSearch Trials of Dallas, LP	Dallas	Texas	United States	75231
51	Pillar Clinical Research, LLC	Dallas	Texas	United States	75243
52	Bayou City Research Corporation	Houston	Texas	United States	77007
53	Clinical Trials of Texas, Inc	San Antonio	Texas	United States	78229
54	Road Runner Research	San Antonio	Texas	United States	78258
55	Family Psychiatry of the Woodlands	The Woodlands	Texas	United States	77381-4546
56	Neuropsychiatric Associates	Woodstock	Vermont	United States	05091
57	NeuroScience, Inc	Herndon	Virginia	United States	20170
58	Summit Research Network LLC	Seattle	Washington	United States	98104
59	Dean Foundation for Health, Research and Education	Middleton	Wisconsin	United States	53562

Sponsors and Collaborators

Sunovion

Investigators

Study Director: SEP-289 Medical Director, MD, Sunovion

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sunovion

ClinicalTrials.gov Identifier:

NCT02276209

Other Study ID Numbers:

SEP360-301

First Posted:

Oct 28, 2014

Last Update Posted:

Aug 28, 2017

Last Verified:

Aug 1, 2017

Additional relevant MeSH terms:

Hyperkinesis

Attention Deficit Disorder with Hyperactivity

Study Results

No Results Posted as of Aug 28, 2017