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Dasotraline Adult ADHD Study

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.
ClinicalTrials.gov Identifier: NCT02276209
Recruitment Status : Completed
First Posted : October 28, 2014
Last Update Posted : August 28, 2017
Sponsor:
Information provided by (Responsible Party):
Sunovion

Tracking Information
First Submitted Date  ICMJE October 21, 2014
First Posted Date  ICMJE October 28, 2014
Last Update Posted Date August 28, 2017
Study Start Date  ICMJE December 2014
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2014)
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. [ Time Frame: 8 Weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02276209 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2014)
  • 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. [ Time Frame: 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. [ Time Frame: 8 Weeks ]
  • Change from baseline in Clinical Global Impression - Severity scale (CGI S) scale at Weeks 1, 2, 4, 6, and 8. [ Time Frame: 8 Weeks ]
  • Change from baseline in Sheehan Depression Scale (SDS) total score at Weeks 4 and 8. [ Time Frame: 8 Weeks ]
  • Change from baseline in Sheehan Depression Scale (SDS) domain scores: work/school, family life, social life at Weeks 4 and 8. [ Time Frame: 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. [ Time Frame: 8 Weeks ]
  • Change from baseline in ADHD Impact Module - Adult AIM A in global domain scores at Weeks 4 and 8. [ Time Frame: 8 Weeks ]
  • Time sensitive ADHD Symptom Scale (TASS) total score and subscale scores (Inattention and Hyperactive impulsive) at Weeks 3, 5, and 7. [ Time Frame: 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. [ Time Frame: 8 Weeks ]
  • Adult ADHD Medication Smoothness of Effect Scale (AMSES) score at Weeks 2, 4, 6, and 8. [ Time Frame: 8 Weeks ]
  • Change from baseline in Pittsburgh Sleep Quality Index (PSQI) global score and 7 component scores at Weeks 2, 4, and 8. [ Time Frame: 8 Weeks ]
  • The incidence of overall AEs, serious AEs (SAEs), and AEs (or SAEs) leading to discontinuations. [ Time Frame: 8 Weeks ]
  • Clinical laboratory evaluations (serum chemistry). [ Time Frame: 8 Weeks ]
  • Clinical laboratory evaluations ( lipid panel). [ Time Frame: 8 Weeks ]
  • Clinical laboratory evaluations (thyroid function panel). [ Time Frame: 8 Weeks ]
  • Clinical laboratory evaluations (hematology). [ Time Frame: 8 Weeks ]
  • Clinical laboratory evaluations (urinalysis). [ Time Frame: 8 Weeks ]
  • Clinical evaluations (vital signs). [ Time Frame: 8 Weeks ]
  • Clinical evaluations (orthostatic effects). [ Time Frame: 8 Weeks ]
  • Clinical evaluations (physical examinations). [ Time Frame: 8 Weeks ]
  • Clinical evaluations (body weight). [ Time Frame: 8 Weeks ]
  • Clinical evaluations (12 lead ECGs). [ Time Frame: 8 Weeks ]
  • Frequency and severity of suicidal ideation and suicidal behavior as assessed by the C SSRS. [ Time Frame: 8 Weeks ]
  • Drug Effects Questionnaire (DEQ) scores at Weeks 1, 2, 4, 6, and 8. [ Time Frame: 8 Weeks ]
  • Symptoms of withdrawal by Physician Withdrawal Checklist (PWC) scores at Week 8, 9, and 10. [ Time Frame: 10 Weeks ]
  • Symptoms of withdrawal by Study Medication Withdrawal Questionnaire (SMWQ) scores at Weeks 9 and 10. [ Time Frame: 10 Weeks ]
  • Symptoms of withdrawal by Hamilton Anxiety Rating Scale (HAM A) scores at Weeks 8, 9, and 10. [ Time Frame: 10 Weeks ]
  • Symptoms of withdrawal by Montgomery-Asberg Depression Rating Scale (MADRS) scores at Weeks 8, 9, and 10. [ Time Frame: 10 Weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dasotraline Adult ADHD Study
Official Title  ICMJE 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)
Brief Summary This is a randomized, double blind, multicenter, parallel group, outpatient study evaluating the efficacy and safety of dasotraline in adults with ADHD.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Adult Attention Deficit Hyperactivity Disorder
Intervention  ICMJE
  • Drug: Dasotraline
    Dasotraline 4 mg once daily
  • Drug: Dasotraline
    Dasotraline 6 mg once daily
  • Other: Placebo
    Placebo once daily
Study Arms  ICMJE
  • Experimental: Dasotraline 4 mg
    Dasotraline 4 mg once daily
    Intervention: Drug: Dasotraline
  • Experimental: Dasotraline 6 mg
    Dasotraline 6 mg once daily
    Intervention: Drug: Dasotraline
  • Placebo Comparator: Placebo
    Placebo once daily
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 3, 2016)
636
Original Estimated Enrollment  ICMJE
 (submitted: October 23, 2014)
600
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02276209
Other Study ID Numbers  ICMJE SEP360-301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sunovion
Study Sponsor  ICMJE Sunovion
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: SEP-289 Medical Director, MD Sunovion
PRS Account Sunovion
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP