Dasotraline Adult ADHD Study

Adult Attention Deficit Hyperactivity Disorder Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02276209
• Other study ID #: SEP360-301
• Status: Completed
• Phase: Phase 3
• First received: October 21, 2014
• Last updated: August 24, 2017
• Start date: December 2014
• Est. completion date: September 2016

Study information

• Verified date: August 2017
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 636
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adult Attention Deficit Hyperactivity Disorder
• Attention Deficit Disorder with Hyperactivity
• Hyperkinesis

Intervention

Drug:
• Dasotraline
Dasotraline 4 mg once daily
• Dasotraline
Dasotraline 6 mg once daily

Other:
• Placebo
Placebo once daily

Locations

Country	Name	City	State
United States	The Institute for Advanced Medical Research	Alpharetta	Georgia
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	FutureSearch Clinical Trials, LP	Austin	Texas
United States	Kennedy Krieger Institute	Baltimore	Maryland
United States	Southern California Research LLC	Beverly Hills	California
United States	Neurobehavioral Medicine Group	Bloomfield Hills	Michigan
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Medical University of SC (MUSC)	Charleston	South Carolina
United States	Center for Emotional Fitness	Cherry Hill	New Jersey
United States	University of Cincinnati, Department of Psychiatry	Cincinnati	Ohio
United States	MCB Clinical Research Centers, LLC	Colorado Springs	Colorado
United States	CNS Clinical Research Group	Coral Springs	Florida
United States	ConnecticutClinicalResearch	Cromwell	Connecticut
United States	FutureSearch Trials of Dallas, LP	Dallas	Texas
United States	Pillar Clinical Research, LLC	Dallas	Texas
United States	iResearch Atlanta, LLC	Decatur	Georgia
United States	Duke Child and Family Study Center	Durham	North Carolina
United States	Triangle Neuropsychiatry	Durham	North Carolina
United States	Pharmacology Research Institute	Encino	California
United States	Gulfcoast Clinical Research	Fort Myers	Florida
United States	Collaborative Neuroscience Network, LLC	Garden Grove	California
United States	NeuroScience, Inc	Herndon	Virginia
United States	Bayou City Research Corporation	Houston	Texas
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	Alpine Clinic	Lafayette	Indiana
United States	Lake Charles Clinical Trials	Lake Charles	Louisiana
United States	Capstone Clinical Research, Inc.	Libertyville	Illinois
United States	Premier Psychiatric Research Institute, LLC	Lincoln	Nebraska
United States	Preferred Research Partners	Little Rock	Arkansas
United States	Florida Clinical Research Center, LLC	Maitland	Florida
United States	Miami Research Associates	Miami	Florida
United States	Dean Foundation for Health, Research and Education	Middleton	Wisconsin
United States	Coastal Carolina Research Center	Mount Pleasant	South Carolina
United States	Eastside Comprehensive Medical Center, LLC	New York	New York
United States	NYU School of Medicine	New York	New York
United States	Village Clinical Research Inc.	New York	New York
United States	Keystone Clinical Studies, LLC	Norristown	Pennsylvania
United States	North County Clinical Research	Oceanside	California
United States	IPS Research Company	Oklahoma City	Oklahoma
United States	Paradigm Research Professionals	Oklahoma City	Oklahoma
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	NoesisPharma,LLC	Phoenix	Arizona
United States	Oregon Center for Clinical Investigations, Inc.	Portland	Oregon
United States	SummitResearchNetwork	Portland	Oregon
United States	Finger Lakes Clinical Research	Rochester	New York
United States	Rochester Center for Behavioral Medicine	Rochester Hills	Michigan
United States	Northwest Behavioral Research Center	Roswell	Georgia
United States	Midwest Research Group	Saint Charles	Missouri
United States	Saint Charles Psychiatric Associates/Midwest Research Group	Saint Charles	Missouri
United States	Oregon Center for Clinical Investigations, Inc.	Salem	Oregon
United States	Clinical Trials of Texas, Inc	San Antonio	Texas
United States	Road Runner Research	San Antonio	Texas
United States	University ot California, San Francisco	San Francisco	California
United States	Summit Research Network LLC	Seattle	Washington
United States	Carman Research	Smyrna	Georgia
United States	Meridien Research	Tampa	Florida
United States	Family Psychiatry of the Woodlands	The Woodlands	Texas
United States	Elite Clinical Trials, Inc.	Wildomar	California
United States	Neuropsychiatric Associates	Woodstock	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Change from baseline in Clinical Global Impression - Severity scale (CGI S) scale at Weeks 1, 2, 4, 6, and 8.		8 Weeks
Secondary	Change from baseline in Sheehan Depression Scale (SDS) total score at Weeks 4 and 8.		8 Weeks
Secondary	Change from baseline in Sheehan Depression Scale (SDS) domain scores: work/school, family life, social life at Weeks 4 and 8.		8 Weeks
Secondary	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
Secondary	Change from baseline in ADHD Impact Module - Adult AIM A in global domain scores at Weeks 4 and 8.		8 Weeks
Secondary	Time sensitive ADHD Symptom Scale (TASS) total score and subscale scores (Inattention and Hyperactive impulsive) at Weeks 3, 5, and 7.		8 Weeks
Secondary	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
Secondary	Adult ADHD Medication Smoothness of Effect Scale (AMSES) score at Weeks 2, 4, 6, and 8.		8 Weeks
Secondary	Change from baseline in Pittsburgh Sleep Quality Index (PSQI) global score and 7 component scores at Weeks 2, 4, and 8.		8 Weeks
Secondary	The incidence of overall AEs, serious AEs (SAEs), and AEs (or SAEs) leading to discontinuations.		8 Weeks
Secondary	Clinical laboratory evaluations (serum chemistry).		8 Weeks
Secondary	Clinical laboratory evaluations ( lipid panel).		8 Weeks
Secondary	Clinical laboratory evaluations (thyroid function panel).		8 Weeks
Secondary	Clinical laboratory evaluations (hematology).		8 Weeks
Secondary	Clinical laboratory evaluations (urinalysis).		8 Weeks
Secondary	Clinical evaluations (vital signs).		8 Weeks
Secondary	Clinical evaluations (orthostatic effects).		8 Weeks
Secondary	Clinical evaluations (physical examinations).		8 Weeks
Secondary	Clinical evaluations (body weight).		8 Weeks
Secondary	Clinical evaluations (12 lead ECGs).		8 Weeks
Secondary	Frequency and severity of suicidal ideation and suicidal behavior as assessed by the C SSRS.		8 Weeks
Secondary	Drug Effects Questionnaire (DEQ) scores at Weeks 1, 2, 4, 6, and 8.		8 Weeks
Secondary	Symptoms of withdrawal by Physician Withdrawal Checklist (PWC) scores at Week 8, 9, and 10.		10 Weeks
Secondary	Symptoms of withdrawal by Study Medication Withdrawal Questionnaire (SMWQ) scores at Weeks 9 and 10.		10 Weeks
Secondary	Symptoms of withdrawal by Hamilton Anxiety Rating Scale (HAM A) scores at Weeks 8, 9, and 10.		10 Weeks
Secondary	Symptoms of withdrawal by Montgomery-Asberg Depression Rating Scale (MADRS) scores at Weeks 8, 9, and 10.		10 Weeks