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Open-label Safety Study in Adults With ADHD

Sponsor
Sunovion (Industry)
Overall Status
Completed
CT.gov ID
NCT02160262
Collaborator
(none)
724
Enrollment
65
Locations
1
Arm
23
Duration (Months)
11.1
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed 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

Study Design

Study Type:
Interventional
Actual Enrollment :
724 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Study Start Date :
Jun 1, 2014
Actual Primary Completion Date :
May 1, 2016
Actual Study Completion Date :
May 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dasotraline

Dasotraline 4 mg, 6 mg, 8 mg, flexibly dosed

Drug: Dasotraline
Dasotraline 4 mg, 6 mg, 8 mg, flexibly dosed, once daily

Outcome Measures

Primary Outcome Measures

  1. The incidence of AEs (or SAEs), and AEs (or SAEs) leading to discontinuation. [12 months]

Secondary Outcome Measures

  1. Clinical evaluations (vital signs, physical examination, body weight, and 12 lead ECG) [12 Months]

  2. Clinical laboratory evaluations (serum chemistry, hematology, lipid panel, thyroid panel, and urinalysis) [12 months]

  3. Drug Effects Questionnaire (DEQ) [12 months]

  4. Frequency and severity of suicidal ideation and suicidal behavior using the Columbia - Suicide Severity Rating Scale (C SSRS) [12 months]

  5. Change from baseline in ADHD RS IV with adult prompts total score [12 months]

  6. Change from baseline in Clinical Global Impression - Severity (CGI S) score [12 months]

  7. Change from baseline in the ADHD RS IV with adult prompts inattentiveness and hyperactivity-impulsivity subscale scores [12 months]

  8. 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]

  9. Change from baseline in Sheehan Disability Scale (SDS) total score [12 months]

  10. Change from baseline in Sheehan Disability Scale (SDS) domain scores: work/school, family life, social life [12 months]

  11. 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]

  12. Change from baseline in Pittsburgh Sleep Quality Index (PSQI) global score and 7 component scores. [12 months]

  13. Change from baseline in BRIEF-A Global Executive Composite T-score and BRI T-score and MI T-score. [12 months]

  14. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Southern California Research LLC Beverly Hills California United States 90210
2 Pharmacology Research Institute Encino California United States 91316
3 Synergy Clinical Research of Escondido Escondido California United States 92025
4 Collaborative Neuroscience Network, LLC Garden Grove California United States 92845
5 Pharmacology Research Institute Los Alamitos California United States 90720
6 Excell Research, Inc Oceanside California United States 92056
7 Artemis Institute for Clinical Research San Diego California United States 92103
8 MCB Clinical Research Centers, LLC Colorado Springs Colorado United States 80910
9 Florida Clinical Research Center LLC Bradenton Florida United States 34208
10 Gulfcoast Clinical Research Fort Myers Florida United States 33912
11 Broward Research Group, Inc. Hollywood Florida United States 33026
12 Geroge M. Joseph MD, PA Jacksonville Beach Florida United States 32350
13 Clinical Neuroscience Solutions, Inc. Jacksonville Florida United States 32256
14 Compass Research North, LLC Leesburg Florida United States 34748
15 Florida Clinical Research Center, LLC Maitland Florida United States 32751
16 Acumentality Melbourne Florida United States 32901
17 Clinical Neuroscience Solutions, Inc Orlando Florida United States 32801
18 Stedman Clinical Trials Tampa Florida United States 33613
19 Institute for Advanced Medical Research Alpharetta Georgia United States 30005
20 Atlanta Center for Medical Research Atlanta Georgia United States 30308
21 iResearch Atlanta, LLC Decatur Georgia United States 30030
22 Carman Research Smyrna Georgia United States 30080
23 Goldpoint Clinical Research Indianapolis Indiana United States 46260
24 Alpine Clinic Lafayette Indiana United States 47905
25 Psychiatric Associates Overland Park Kansas United States 90720
26 Lake Charles Clinical Trials LLC Lake Charles Louisiana United States 70601
27 Kennedy Krieger Institute Baltimore Maryland United States 21205
28 Massachusetts General Hospital Boston Massachusetts United States 02114
29 Rochester Center for Behavioral Medicine Rochester Hills Michigan United States 48307
30 Psychiatric Care & Research Center O'Fallon Missouri United States 63368
31 Midwest Research Group Saint Charles Missouri United States 63304
32 Premeir Psychiatric Research Institute, LLC Lincoln Nebraska United States 68526
33 Center for Psychiatry and Behavioral Medicine, Inc. Las Vegas Nevada United States 89128
34 Center for Emotional Fitness Cherry Hill New Jersey United States 08002
35 Bioscience Research Mount Kisco New York United States 10549
36 Village Clinical Research Inc. New York New York United States 10003
37 NYU School of Medicine New York New York United States 10016
38 Medical & Behavioral Health Research New York New York United States 10023
39 The Medical Research Network, LLC New York New York United States 10128
40 Fieve Clinical Research New York New York United States 10168
41 Woodhull Medical & Mental Health Center Staten Island New York United States 10305
42 Richmond Behavioral Associates Staten Island New York United States 10312
43 Duke University Medical Center Durham North Carolina United States 27705
44 Neuro-Behavioral Clinical Research Canton Ohio United States 44718
45 Midwest Clinical Research Center Dayton Ohio United States 32350
46 IPS Research Company Oklahoma City Oklahoma United States 73103
47 Cutting Edge Research Group Oklahoma City Oklahoma United States 73116
48 Summit Research Network Portland Oregon United States 97210
49 Oregon Center for Clinical Investigations, Inc. Portland Oregon United States 97214
50 Suburban Research Associates Media Pennsylvania United States 19063
51 Keystone Clinical Studies, LLC Norristown Pennsylvania United States 19403
52 Sleep Diagnosists and Treatment Centers West Chester Pennsylvania United States 19380
53 Coastal Carolina Research Center Mount Pleasant South Carolina United States 29464
54 Clinical Neuroscience Solutions Memphis Tennessee United States 38119
55 Research Strategies of Memphis, LLC Memphis Tennessee United States 38119
56 FutureSearch Trials of Dallas, LP Dallas Texas United States 75231
57 Pillar Clinical Research, LLC Dallas Texas United States 75243
58 Houston Clinical Trials, LLC Houston Texas United States 77098
59 Clinical Trials of Texas, Inc San Antonio Texas United States 78229
60 Family Psychiatry of the Woodlands The Woodlands Texas United States 77381
61 Neuropsychiatric Associates Woodstock Vermont United States 05091
62 NeuroScience, Inc Herndon Virginia United States 20170
63 Summit Research Network (Seattle) LLC Seattle Washington United States 98104
64 Dean Foundation Middleton Wisconsin United States 53562
65 Eastside Therapeutic Resource Middleton Wisconsin United States 53562

Sponsors and Collaborators

  • Sunovion

Investigators

  • Study Director: SEP289 Medical Director, Sunovion

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sunovion
ClinicalTrials.gov Identifier:
NCT02160262
Other Study ID Numbers:
  • SEP360-304
First Posted:
Jun 10, 2014
Last Update Posted:
May 2, 2017
Last Verified:
May 1, 2017
Additional relevant MeSH terms:
Hyperkinesis
Attention Deficit Disorder with Hyperactivity

Study Results

No Results Posted as of May 2, 2017