NCT04016779已完成3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Flexible-Dose Study of the Efficacy and Safety of SPN-812 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 374
- 试验地点
- 33
- 主要终点
- Efficacy of SPN-812 on Symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) as Assessed by the Adult ADHD Investigator Symptom Rating Scale (AISRS) Total Score
研究概览
简要总结
This study will evaluate the efficacy and safety of SPN-812 (Viloxazine extended-release capsules; 200-600 mg) in adults 18-65 years of age with Attention-Deficit/Hyperactivity Disorder (ADHD).
详细描述
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, 2-arm, parallel-group, flexible dose trial assessing the efficacy and safety of SPN-812 (Viloxazine extended-release capsules; 200-600 mg) as monotherapy for the treatment of adults 18-65 years old with Attention-Deficit/Hyperactivity Disorder (ADHD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is male or female, aged 18 to ≤ 65 years at screening.
- •Is able to read and understand the Informed Consent Form (ICF).
- •Written informed consent obtained from the subject (a signed ICF).
- •Weight within the normal or overweight ranges according to accepted values of the Body Mass Index Chart (18.0 to 35 kg/m2).
- •Is able to swallow capsules whole, without crushing, chewing or cutting.
- •Is willing and able to attend study appointments within the specified time windows.
- •Has a primary diagnosis of ADHD according to the DSM-5 classification, with diagnosis made at least 6 months prior to screening and confirmed with Structured Clinical Interview for DSM-5 Clinical Trials version (SCID-5-CT).
- •Has an AISRS Adult ADHD (Attention-Deficit/Hyperactivity Disorder) Investigator Symptom Rating Scale total score of ≥ 26 at the Screening Visit and at the Baseline Visit (V2, Day 1).
- •Has a CGI-S score of ≥ 4 (moderately ill or worse) at the Screening Visit (V1) and Baseline Visit (V2, Day 1).
- •Females of childbearing potential (FOCP) must be either sexually inactive (abstinent) or, if sexually active, must agree to use one of the following acceptable birth control methods beginning 30 days prior to the first dose of SM and throughout the study:
- •Simultaneous use of male condom and intra-uterine contraceptive device placed at least 4 weeks prior to first SM administration
- •Surgically sterile male partner
- •Simultaneous use of male condom and diaphragm with spermicide
- •Established hormonal contraceptive
- •Females are considered not to be of childbearing potential if they are either post-menopausal (amenorrhea for at least 2 years and serum follicle stimulating hormone (FSH) level of >40 IU/L) or permanently sterilized (e.g., bilateral tubal ligation, hysterectomy, bilateral oophorectomy for 6 months minimum prior to screening).
- •Males must:
- •Use 2 methods of contraception in combination if his female partner is of childbearing potential; this combination of contraceptive methods must be used from the Baseline Visit to ≥ 1 month after the last dose of SM, or
- •Have been surgically sterilized prior to the Screening Visit.
排除标准
- •Has previously enrolled in a SPN-812 study.
- •Is currently participating in another clinical trial or has participated in a clinical trial within 60 days prior to the first Screening Visit.
- •Is a member of the study personnel or of their immediate families, or is a subordinate (or immediate family member of a subordinate) to any of the study personnel.
- •Female subjects who are pregnant, lactating and/or sexually active and not agreeing to use one of the acceptable birth control methods throughout the study.
- •Has history of severe drug allergy or hypersensitivity, or known hypersensitivity, to the study medication or excipients.
- •Has history of moderate or severe head trauma or other neurological disorder or systemic medical disease that, in the Investigator's opinion, is likely to affect central nervous system functioning. This would include subjects with:
- •A current diagnosis of a major neurological disorder; or
- •Seizures, seizure disorder or seizure-like events; or a history of seizure disorder within the immediate family (siblings, parents); or
- •Encephalopathy
- •Has any history of schizophrenia, schizoaffective disorder, bipolar disorder, borderline personality disorder, antisocial personality disorder, narcissistic personality disorder, autism, post-traumatic stress disorder or obsessive-compulsive disorder.
- •Has any current psychiatric disorder (per DSM-5 criteria) other than ADHD with the following exceptions: ADHD is primary diagnosis with comorbidity/secondary diagnoses of major depression disorder (MDD), nicotine dependence, social anxiety disorder, generalized anxiety disorder, or phobias, and subject is not receiving pharmacological treatment for the comorbidity/secondary diagnoses (e.g., antidepressant for MDD) at time of screening nor for the duration of study.
- •Has a Symptoms of Depression Questionnaire (SDQ) mean score >3.0 at screening.
- •Has a Hamilton Anxiety Rating Scale (HAM-A) score of > 21 at screening.
- •Has organic mental disorders, or mental disorders due to a general medical condition (per DSM-5 criteria).
- •Has a current diagnosis or history of substance use disorder including alcohol use disorder (excluding nicotine and caffeine) (per DSM-5 criteria) within the 12 months prior to screening; or is assessed by the Investigator as having regularly consumed alcohol exceeding 21 units for males and 14 units for females per week (1 unit equals 340 mL of beer, 115 mL of wine, or 43 mL of spirits) within the 12 months prior to screening.
- •Is currently using, or has a positive result on the drug screening at the Screening Visit for drugs of abuse (alcohol, opiates, methadone, cocaine, methamphetamine [including ecstasy], phencyclidine, propoxyphene, methylphenidate, barbiturates, and benzodiazepines). If subject's serum drug screen for ethanol is positive at Screening (V1) and the investigator determines subject does not have alcohol use disorder, then the subject may have a repeat serum drug screen for ethanol performed before baseline within the allotted screening period (results must be received prior to V2 baseline). If second serum drug screen for ethanol is positive, subject is excluded from participating in the study, however, if second serum drug screen for ethanol is negative, subject may proceed to V
- •Is a (known or self-identified) current habitual/chronic cannabis user (medicinal or recreational); or
- •Has a positive urine drug screen for cannabis at the Screening Visit and is considered, per the Investigator's judgement, to be a habitual/chronic cannabis user; or
- •Has a positive urine drug screen for cannabis at both the screening and follow-up drug screen at the Baseline Visit, even though the subject is not considered, per the Investigator's judgement, to be a habitual/chronic cannabis user.
- •Note: Subjects who have a positive urine drug screen for cannabis at the Screening Visit but who are not considered to be a habitual/chronic cannabis user per the Investigator's judgement may, with Sponsor approval, undergo an additional urine drug screen at least 4 weeks after the original urine drug screen at Baseline Visit, prior to randomization. Subjects must agree to refrain from cannabis use throughout study.
- •Has treatment-resistant ADHD based on a history of receipt of >2 approved ADHD medications that failed to adequately improve the subject's symptoms. A subject who is naïve to ADHD treatment is not excluded from study participation.
- •Has any other disorder for which its treatment takes priority over treatment of ADHD or is likely to interfere with study treatment, impair treatment compliance, or interfere with interpretation of study results.
- •Has history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin that has not been in remission for > 5 years prior to the first dose of SM.
- •Has or has had one or more of the following conditions considered clinically significant/relevant by the Investigator in the context of the study:
- •cardiovascular disease
- •congestive heart failure
- •cardiac hypertrophy
- •arrhythmia
- •bradycardia (pulse < 50 bpm)
- •tachycardia (pulse > 100 bpm)
- •respiratory disease
- •hepatic impairment or renal insufficiency
- •metabolic disorder
- •endocrine disorder
- •gastrointestinal disorder
- •hematological disorder
- •infectious disorder
- •any clinically significant immunological condition
- •dermatological disorder
- •Exhibits clinically significant abnormal vital signs at screening.
- •Has one or more screening clinical laboratory test values outside the reference range that, in the opinion of the Investigator, are clinically significant, or any of the following:
- •Serum creatinine > 1.5 times the upper limit of normal (ULN);
- •Serum total bilirubin > 1.5 times ULN;
- •Serum alanine aminotransferase or aspartate aminotransferase > 2 times ULN.
- •Has any of the following cardiology findings at screening:
- •Abnormal ECG that is, in the Investigator's opinion, clinically significant;
- •PR interval > 220 ms;
- •QRS interval > 130 ms;
- •QTcF interval > 450 ms (for men) or > 470 ms (for women) (QT corrected using Fridericia's method);
- •Second- or third-degree atrioventricular block;
- 另有 8 项未显示
研究组 & 干预措施
SPN-812
Experimental
SPN-812, qd, oral capsule
干预措施: SPN-812 (Drug)
Placebo
Placebo Comparator
Placebo, qd, oral capsule
干预措施: Placebo (Drug)
结局指标
主要结局
Efficacy of SPN-812 on Symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) as Assessed by the Adult ADHD Investigator Symptom Rating Scale (AISRS) Total Score
时间窗: Baseline and Week 6
The Primary Endpoint was the change from baseline in the Adult ADHD Investigator Symptom Rating Scale (AISRS) Total score at Week 6. The AISRS is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology in adults. The AISRS consists of 18 items that directly correspond to the 18 symptoms of ADHD per the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). The scale is subdivided into two subscales: Inattention (9 items) and Hyperactivity/Impulsivity (9 items). The clinician/investigator rates the subject on each item using a 4-point scale, where 0=none, 1=mild, 2=moderate, and 3=severe. A Total score is calculated by summating the ratings of all 18 items (range: 0-54; the higher the score, the more severe the ADHD symptoms). A lower change from baseline AISRS Total score (\<0) represents a better outcome.
次要结局
- Effect of SPN-812 on Clinical Response Rate as Assessed by the Clinical Global Impression - Improvement (CGI-I) Scale(Week 6)
- Effect of SPN-812 on Hyperactivity/Impulsivity Symptoms as Assessed by the Hyperactivity/Impulsivity Subscale of the Adult ADHD Investigator Symptom Rating Scale (AISRS)(Baseline and Week 6)
- Effect of SPN-812 on the Clinical Response Rate as Assessed by the Clinical Global Impression - Severity of Illness (CGI-S) Scale(Week 6)
- Effect of SPN-812 on the "Emotional Control" Scale of the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)(Baseline and Week 6)
- Effect of SPN-812 on Symptoms of Anxiety as Assessed by the Generalized Anxiety Disorder 7-Item (GAD-7) Scale(Baseline and Week 6)
- Effect of SPN-812 on the Behavioral Regulation Index (BRI) of the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)(Baseline and Week 6)
- Effect of SPN-812 on the "Self-Monitor" Scale of the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)(Baseline and Week 6)
- Effect of SPN-812 on 30% Clinical Response Rate as Assessed by the Adult ADHD Investigator Symptom Rating Scale (AISRS)(Baseline and Week 6)
- Effect of SPN-812 on the Clinical Global Impression - Severity of Illness (CGI-S) Scale(Baseline and Week 6)
- Effect of SPN-812 on the Clinical Global Impression - Improvement (CGI-I) Scale(Week 6)
- Effect of SPN-812 on Inattention Symptoms as Assessed by the Inattention Subscale of the Adult ADHD Investigator Symptom Rating Scale (AISRS)(Baseline and Week 6)
- Effect of SPN-812 on 50% Clinical Response Rate as Assessed by the Adult ADHD Investigator Symptom Rating Scale (AISRS).(Baseline and Week 6)
- Effect of SPN-812 on the Global Executive Composite (GEC) of the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)(Baseline and Week 6)
- Effect of SPN-812 on the "Inhibit" Scale of the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)(Baseline and Week 6)
- Effect of SPN-812 on the "Shift" Scale of the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)(Baseline and Week 6)
- Effect of SPN-812 on the Metacognitive Index (MI) of the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)(Baseline and week 6)
- Effect of SPN-812 on the "Initiate" Scale of the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)(Baseline and Week 6)
- Effect of SPN-812 on the "Plan/Organize" Scale of the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)(Baseline and Week 6)
- Effect of SPN-812 on the "Task Monitor" Scale of the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)(Baseline and Week 6)
- Effect of SPN-812 on the "Organization of Materials" Scale of the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)(Baseline and Week 6)
- Effect of SPN-812 on the "Working Memory" Scale of the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)(Baseline and Week 6)
研究者
研究点 (33)
Loading locations...
相似试验
招募中
4 期
Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHDAttention-Deficit/Hyperactivity DisorderNCT04781140Supernus Pharmaceuticals, Inc.286
进行中（未招募）
3 期
Masupirdine for the Treatment of Agitation in Dementia of the Alzheimer's TypeAgitationAlzheimer's Type DementiaNCT05397639Suven Life Sciences Limited375
终止
2 期
Evaluation of the Efficacy and Safety of VX-814 in Subjects With the PiZZ GenotypeAlpha 1-Antitrypsin DeficiencyNCT04167345Vertex Pharmaceuticals Incorporated48
已完成
3 期
Fixed-Dose Trial in Early Parkinson's Disease (PD)Parkinson DiseaseNCT04201093AbbVie529
已完成
3 期
Efficacy and Safety of Adult Human Mesenchymal Stem Cells to Treat Steroid Refractory Acute Graft Versus Host Disease (GVHD)Graft Versus Host DiseaseNCT00366145Mesoblast, Inc.260