Open-label Safety Study in Adults With ADHD

Adult Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

A Phase 3, 12-Month, Multicenter, Open-label, Flexibly-dosed, Safety Study of SEP 225289 in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02160262
• Other study ID #: SEP360-304
• Status: Completed
• Phase: Phase 3
• First received: June 8, 2014
• Last updated: May 1, 2017
• Start date: June 2014
• Est. completion date: May 2016

Study information

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

Clinical Trial Summary

To evaluate the long-term safety and tolerability of SEP 225289 in adult subjects with Attention Deficit Hyperactivity Disorder (ADHD)

Description:

To evaluate the long-term safety and tolerability of SEP 225289 in adult subjects with ADHD by the incidence of adverse events (AEs; or serious AEs), AEs (or SAEs) leading to discontinuation

Recruitment information / eligibility

• Status: Completed
• Enrollment: 724
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Subject meets DSM 5 criteria for a primary diagnosis of ADHD (inattentive, hyperactive, or combined presentation) established by a comprehensive psychiatric evaluation that reviews DSM 5 criteria. Diagnosis is confirmed by CAADID Part 2 with checklist for DSM 5.

• Subject has an ADHD RS IV with adult prompts score of = 22 at screening and baseline.

• Subject has agreed to participate by providing written informed consent and is willing and able to comply with the protocol, in the opinion of the investigator.

• Subject is 18 to 55 years old, inclusive, at the time of informed consent.

• Subject is male or a non-pregnant, non lactating female.

• Female subjects must have a negative serum pregnancy test; 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 throughout the study period.

• Subject has a negative breath alcohol test and a negative urine drug screen (UDS) for any illicit drug at screening.

• Subject is judged by the investigator to be suitable for participation in a 12 month clinical trial involving open-label dasotraline treatment.

• Subject can read well enough to understand the informed consent form and other subject materials.

Exclusion Criteria:

• Subject has a psychiatric disorder other than ADHD that has been the primary focus of treatment at any time during the 12 months prior to 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, or a personality disorder per DSM 5 criteria.

• 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 5 criteria.

• 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.

• Subject has a currently active medical condition (other than ADHD) that, in the opinion of the investigator, could interfere with the ability of the subject to participate in the study.

• Subject is currently taking or has taken within the previous 6 months an anticonvulsant medication (eg, phenytoin, carbamazepine, lamotrigine, valproic acid, etc); antipsychotic medication; or lithium (any lithium preparation or formulation).

• Subject is currently taking an alpha 2 adrenergic receptor agonist (including clonidine and guanfacine), or serotonin-norepinephrine reuptake inhibitor (SNRI; eg, venlafaxine), or dopamine-norepinephrine reuptake inhibitor (DNRI; eg, bupropion), or monoamine oxidase [MAO] inhibitor. Note: Subjects who discontinue these medications and wash-out from them for a minimum of 7 days prior to the first dose of study drug will be allowed to enroll in the study.

• Subject is currently undergoing Cognitive Behavioral Therapy (CBT).

• Subject has a Body Mass Index (BMI) less than 18 or greater than 35 kg/m2 (see Appendix V).

• 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 1 year prior to 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 for the reference lab.

• 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 serum chemistry results show an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value = 2 times the upper limit of normal (ULN), or a blood urea nitrogen (BUN) value = 1.5 times the ULN for the reference laboratory.

• 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.

• 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 has previously been randomized in a clinical trial of dasotraline.

• Subject is likely to be noncompliant in the investigator's opinion.

• 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, 6 mg, 8 mg, flexibly dosed, once daily

Locations

Country	Name	City	State
United States	Institute for Advanced Medical Research	Alpharetta	Georgia
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Kennedy Krieger Institute	Baltimore	Maryland
United States	Southern California Research LLC	Beverly Hills	California
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Florida Clinical Research Center LLC	Bradenton	Florida
United States	Neuro-Behavioral Clinical Research	Canton	Ohio
United States	Center for Emotional Fitness	Cherry Hill	New Jersey
United States	MCB Clinical Research Centers, LLC	Colorado Springs	Colorado
United States	FutureSearch Trials of Dallas, LP	Dallas	Texas
United States	Pillar Clinical Research, LLC	Dallas	Texas
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	iResearch Atlanta, LLC	Decatur	Georgia
United States	Duke University Medical Center	Durham	North Carolina
United States	Pharmacology Research Institute	Encino	California
United States	Synergy Clinical Research of Escondido	Escondido	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	Broward Research Group, Inc.	Hollywood	Florida
United States	Houston Clinical Trials, LLC	Houston	Texas
United States	Goldpoint Clinical Research	Indianapolis	Indiana
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	Geroge M. Joseph MD, PA	Jacksonville Beach	Florida
United States	Alpine Clinic	Lafayette	Indiana
United States	Lake Charles Clinical Trials LLC	Lake Charles	Louisiana
United States	Center for Psychiatry and Behavioral Medicine, Inc.	Las Vegas	Nevada
United States	Compass Research North, LLC	Leesburg	Florida
United States	Premeir Psychiatric Research Institute, LLC	Lincoln	Nebraska
United States	Pharmacology Research Institute	Los Alamitos	California
United States	Florida Clinical Research Center, LLC	Maitland	Florida
United States	Suburban Research Associates	Media	Pennsylvania
United States	Acumentality	Melbourne	Florida
United States	Clinical Neuroscience Solutions	Memphis	Tennessee
United States	Research Strategies of Memphis, LLC	Memphis	Tennessee
United States	Dean Foundation	Middleton	Wisconsin
United States	Eastside Therapeutic Resource	Middleton	Wisconsin
United States	Bioscience Research	Mount Kisco	New York
United States	Coastal Carolina Research Center	Mount Pleasant	South Carolina
United States	Fieve Clinical Research	New York	New York
United States	Medical & Behavioral Health Research	New York	New York
United States	NYU School of Medicine	New York	New York
United States	The Medical Research Network, LLC	New York	New York
United States	Village Clinical Research Inc.	New York	New York
United States	Keystone Clinical Studies, LLC	Norristown	Pennsylvania
United States	Psychiatric Care & Research Center	O'Fallon	Missouri
United States	Excell Research, Inc	Oceanside	California
United States	Cutting Edge Research Group	Oklahoma City	Oklahoma
United States	IPS Research Company	Oklahoma City	Oklahoma
United States	Clinical Neuroscience Solutions, Inc	Orlando	Florida
United States	Psychiatric Associates	Overland Park	Kansas
United States	Oregon Center for Clinical Investigations, Inc.	Portland	Oregon
United States	Summit Research Network	Portland	Oregon
United States	Rochester Center for Behavioral Medicine	Rochester Hills	Michigan
United States	Midwest Research Group	Saint Charles	Missouri
United States	Clinical Trials of Texas, Inc	San Antonio	Texas
United States	Artemis Institute for Clinical Research	San Diego	California
United States	Summit Research Network (Seattle) LLC	Seattle	Washington
United States	Carman Research	Smyrna	Georgia
United States	Richmond Behavioral Associates	Staten Island	New York
United States	Woodhull Medical & Mental Health Center	Staten Island	New York
United States	Stedman Clinical Trials	Tampa	Florida
United States	Family Psychiatry of the Woodlands	The Woodlands	Texas
United States	Sleep Diagnosists and Treatment Centers	West Chester	Pennsylvania
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	The incidence of AEs (or SAEs), and AEs (or SAEs) leading to discontinuation.		12 months
Secondary	Clinical evaluations (vital signs, physical examination, body weight, and 12 lead ECG)		12 Months
Secondary	Clinical laboratory evaluations (serum chemistry, hematology, lipid panel, thyroid panel, and urinalysis)		12 months
Secondary	Drug Effects Questionnaire (DEQ)		12 months
Secondary	Frequency and severity of suicidal ideation and suicidal behavior using the Columbia - Suicide Severity Rating Scale (C SSRS)		12 months
Secondary	Change from baseline in ADHD RS IV with adult prompts total score		12 months
Secondary	Change from baseline in Clinical Global Impression - Severity (CGI S) score		12 months
Secondary	Change from baseline in the ADHD RS IV with adult prompts inattentiveness and hyperactivity-impulsivity subscale scores		12 months
Secondary	Change from baseline in AIM A in global domain scores (Performance and Daily Functioning, Impact of Symptoms: Daily Interference, Impact of Symptoms: Bother/Concern, Relationships/Communication, Living with ADHD, and General Well-being)		12 months
Secondary	Change from baseline in Sheehan Disability Scale (SDS) total score		12 months
Secondary	Change from baseline in Sheehan Disability Scale (SDS) domain scores: work/school, family life, social life		12 months
Secondary	Change from baseline in Behavior Rating Inventory of Executive Function®-Adult Version (BRIEF®) A Global Executive Composite raw score and Behavioral Regulation Index (BRI) raw score and Metacognition Index (MI) raw score.		12 months
Secondary	Change from baseline in Pittsburgh Sleep Quality Index (PSQI) global score and 7 component scores.		12 months
Secondary	Change from baseline in BRIEF-A Global Executive Composite T-score and BRI T-score and MI T-score.		12 months
Secondary	Symptoms of withdrawal using Physician Withdrawal Checklist (PWC) scores, Study Medication Withdrawal Questionnaire (SMWQ) scores, Montgomery-Asberg Depression Rating Scale (MADRS) scores, Hamilton Anxiety Rating Scale (HAM-A) scores		12 months