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Open-label Safety Study in Adults With ADHD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02160262
Recruitment Status : Completed
First Posted : June 10, 2014
Last Update Posted : May 2, 2017
Information provided by (Responsible Party):

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
Adult Attention Deficit Hyperactivity Disorder Drug: Dasotraline 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

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Study Type : Interventional  (Clinical Trial)
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 : June 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. The incidence of AEs (or SAEs), and AEs (or SAEs) leading to discontinuation. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Clinical evaluations (vital signs, physical examination, body weight, and 12 lead ECG) [ Time Frame: 12 Months ]
  2. Clinical laboratory evaluations (serum chemistry, hematology, lipid panel, thyroid panel, and urinalysis) [ Time Frame: 12 months ]
  3. Drug Effects Questionnaire (DEQ) [ Time Frame: 12 months ]
  4. Frequency and severity of suicidal ideation and suicidal behavior using the Columbia - Suicide Severity Rating Scale (C SSRS) [ Time Frame: 12 months ]
  5. Change from baseline in ADHD RS IV with adult prompts total score [ Time Frame: 12 months ]
  6. Change from baseline in Clinical Global Impression - Severity (CGI S) score [ Time Frame: 12 months ]
  7. Change from baseline in the ADHD RS IV with adult prompts inattentiveness and hyperactivity-impulsivity subscale scores [ Time Frame: 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) [ Time Frame: 12 months ]
  9. Change from baseline in Sheehan Disability Scale (SDS) total score [ Time Frame: 12 months ]
  10. Change from baseline in Sheehan Disability Scale (SDS) domain scores: work/school, family life, social life [ Time Frame: 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. [ Time Frame: 12 months ]
  12. Change from baseline in Pittsburgh Sleep Quality Index (PSQI) global score and 7 component scores. [ Time Frame: 12 months ]
  13. Change from baseline in BRIEF-A Global Executive Composite T-score and BRI T-score and MI T-score. [ Time Frame: 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 [ Time Frame: 12 months ]

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02160262

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Sponsors and Collaborators
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Study Director: SEP289 Medical Director Sunovion
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Responsible Party: Sunovion Identifier: NCT02160262    
Other Study ID Numbers: SEP360-304
First Posted: June 10, 2014    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases