NL-OMON55836招募中4 期
A Phase 4, Multicenter, 2-part Study Composed of a 1-Year Randomized, Double-blind, Parallel-group, Placebo-controlled, Active-comparator, Dose-optimization Evaluation followed by a 1-Year Open-label Evaluation to Assess the Safety and Efficacy of Guanfacine Hydrochloride Prolonged-release (SPD503) in Children and Adolescents aged 6 to 17 Years with Attention-Deficit/Hyperactivity Disorder - SPD503-401
Takeda0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 17（—）
入选标准
- •1. Subject is a male or female aged 6 to 17 years inclusive at the time of
- •consent/assent.
- •2. Subject must meet DSM-5 criteria for a primary diagnosis of ADHD based on a
- •detailed psychiatric evaluation using the Kiddie-Schedule for Affective
- •Disorders-Present and Lifetime Version (K-SADS-PL)at screening (Visit 1A).
- •3. Subject for whom prior stimulant therapy is not suitable, not tolerated, or
- •shown to be ineffective as determined by investigator clinical assessment and
- •review of the Prior Stimulant Medication Questionnaire (PSMQ) administered
- •during screening (Visit 1A).
- •4. Subject has an ADHD-RS-5 total score >=28 at baseline (Visit 2A).
- •5. Subject has a baseline (Visit 2A) CGI-S score >=4.
- •6. Subject who is a female of childbearing potential (FOCP) and postmenarchal
- •must have a negative serum beta-human chorionic gonadotropin (β-hCG) pregnancy
- •test at screening (Visit 1A) and a negative urine pregnancy test at baseline
- •(Visit 2A), be nonlactating, and agree to comply with any applicable
- •contraceptive requirements described in the protocol. Female of childbearing
- •potential is defined as any female subject who is at least aged 9 years or
- •younger than 9 years and postmenarchal.
- •7. Subject*s parent or legally authorized representative (LAR) must provide
- •signature of informed consent. Documentation of assent (if applicable) must be
- •provided by the subject indicating that the subject is aware of the
- •investigational nature of the study and the required procedures and
- •restrictions in accordance with the International Council for Harmonisation
- •(ICH) Good Clinical Practice (GCP) Guideline E6 and applicable regulations,
- •before completing any study-related procedures.
- •8. Subject and parent/LAR are willing and able to comply with all the testing
- •and requirements defined in this protocol, including oversight of morning
- •dosing. Specifically, the parent/LAR must be available for the duration of the
- •study to administer the IMP dose each morning when the subject awakens.
- •9. Subject has supine and standing blood pressure (BP) measurements within the
- •95th percentile for age, sex, and height at both screening (Visit 1A) and
- •baseline (Visit 2A).
- •10. Subject is functioning at an age-appropriate level intellectually, as
- •judged by the investigator.
- •11. Subject is able to swallow intact tablets.
排除标准
- •1. Subject has a current, controlled (requiring medication or therapy) or
- •uncontrolled, comorbid psychiatric disorder (except oppositional defiant
- •disorder), including but not limited to any of the following comorbid Axis I
- •and Axis II disorders (the K-SADS-PL should be reviewed to confirm diagnosis,
- •if necessary):
- •a. Posttraumatic stress disorder (PTSD)
- •b. Bipolar illness, psychosis, or family history in either biological parent
- •c. Pervasive developmental disorder
- •d. Obsessive-compulsive disorder (OCD)
- •e. Psychosis/schizophrenia
- •f. Serious tic disorder or a family history of Tourette*s disorder
- •2. Subject is currently considered to be a suicide risk by the investigator;
- •has made a previous suicide attempt; has a history of, or currently
- •demonstrating, active suicidal ideation.
- •3. Subject has a substance abuse disorder as defined by DSM-5 criteria or has
- •been suspected of a substance abuse or dependence disorder (except nicotine)
- •within the past 6 months.
- •4. Subject has a clinically important abnormality on the urine drug and/or
- •alcohol screen at screening.
- •5. Subject has been physically, sexually, and/or emotionally abused.
- •6. Subject has any other disorder that as judged by the investigator could
- •contraindicate TAK-503 or confound the results of the safety and efficacy
- •assessments.
- •7. Subject has any condition or illness including any clinically significant
- •abnormal laboratory value at screening (Visit 1A) or, if the laboratory test
- •was repeated, at baseline (Visit 2A) that, as judged by the investigator, would
- •be an inappropriate risk to the subject and/or could confound the
- •interpretation of study results.
- •8. Subject has current abnormal thyroid function, defined as abnormal
- •thyroid-stimulating hormone and thyroxine at screening (Visit 1A). Treatment
- •with a stable dose of thyroid medication for >=3 months before screening will be
- •9. Subject has a known history or presence of: malignancy (except nonmelanoma
- •skin cancer), pregnancy, and/or a developmental delay or abnormality associated
- •with growth or sexual maturation delays that are not related to ADHD.
- •10. Children aged 6 to 12 years with a body weight <25.0 kg or adolescents aged
- •>=13 years with a body weight <34.0 kg at screening (Visit 1A) or baseline
- •(Visit 2A).
- •11. Subject is significantly overweight based on the Centers for Disease
- •Control (CDC) BMI-for-age sex-specific charts at screening (Visit 1A) or
- •baseline (Visit 2A). For this study, significantly overweight will be defined
- •as a BMI that is greater than the 95th percentile.
- •12. Subject has a known history or presence of: structural cardiac
- •abnormalities, serious heart rhythm abnormalities, syncope, cardiac conduction
- •problems (eg, clinically significant heart block or QT interval prolongation),
- •bradycardia, or exercise-related cardiac events including syncope and
- •presyncope.
- •13. Subject has clinically significant ECG findings, as judged by the
- •investigator, at baseline (Visit 2A).
- •14. Subject has orthostatic hypotension or a known history of hypertension.
- •15. Subject has a known family history of sudden cardiac death or ventricular
- 另有 4 项未显示
研究者
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