NL-OMON31918已完成3 期
A phase III, randomised, double-blind, multicentre, parallel-group, placebo- and active-controlled, dose-optimisation safety and efficacy study of Lisdexamfetamine Dimesylate (LDX) in children and adolescents aged 6-17 with attention-deficit/hyperactivity disorder (ADHD) - SPD489-325
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
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*s parent or legally authorised representative (LAR) must provide signature of informed consent, and there must be documentation of assent (if applicable) 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 Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6 and applicable regulations before completing any study-related procedures.
- •2. 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 upon awakening, at approximately 7:00AM, to dispense the dose of study drug for the duration of the study.
- •3. Subject is a male or female aged 6-17 years inclusive at the time of consent.
- •4. Subject must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM IV TR) criteria for a primary diagnosis of ADHD based on a detailed psychiatric evaluation.
- •5. Subject must have a Baseline ADHD-RS-IV total score >=28.
- •6. Subject, who is a female of childbearing potential (FOCP), must have a negative serum beta human chorionic gonadotropin (HCG) pregnancy test at Screening and a negative urine pregnancy test at Baseline and agree to comply with any applicable contraceptive requirements of the protocol.
- •7. Subject has blood pressure measurements within the 95th percentile for age, gender, and height at Screening and Baseline.
- •8. Subject is functioning at an age-appropriate level intellectually, as deemed by the study investigator.
- •9. Subject is able to swallow a capsule.
排除标准
- •1. Subject has failed to respond to more than one adequate course (dose and duration) of stimulant therapy. One course must have been a long-acting formulation.
- •2. Subject has a current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as any severe comorbid Axis II disorder or severe Axis I disorder (such as Post Traumatic Stress Disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, anorexia nervosa, severe depressive or severe anxiety disorder) or other symptomatic manifestations, such as agitated states, marked anxiety, or tension that, in the opinion of the examining physician, will contraindicate treatment with LDX or CONCERTA® XL or confound efficacy or safety assessments. Comorbid psychiatric diagnoses will be established with the Screening interview of the Kiddie-SADS-Present and Lifetime - Diagnostic Interview (K SADS-PL) and additional modules if warranted by the results of the initial interview. Subjects may continue participating in behavioural therapy during this study as long as they have been receiving the therapy for at least 1 month at the time of the Baseline Visit.
- •3. Subject has a conduct disorder. Oppositional Defiant Disorder is not exclusionary.
- •4. Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or an infectious process requiring antibiotics), disability, or other condition that might confound the results of safety assessments conducted in the study or that might increase risk to the subject. Similarly, the subject will be excluded if he or she has any additional condition(s) that, in the Investigator*s opinion, would prohibit the subject from completing the study or would not be in the best interest of the subject. The additional condition(s) would include any significant illness or unstable medical condition that could lead to difficulty complying with the protocol. Mild, stable asthma is not exclusionary.
- •5. Subject is currently considered a suicide risk, has previously made a suicide attempt or has a prior history of, or is currently, demonstrating active suicidal ideation.
- •6. Subject is female and is pregnant or lactating.
- •7. Subject has glaucoma.
- •8. Subject weighs less than 22.7kg (50lbs).
- •9. Subject is significantly overweight based on Centre for Disease Control and Prevention Body Mass Index (BMI)-for-age gender specific charts at Screening. Significantly overweight is defined as a BMI >97th percentile for this study.
- •10. Subject has a positive urine drug result at Screening (with the exception of subject*s current ADHD therapy).
- •11. Subject has current abnormal thyroid function, defined as abnormal thyroid stimulating hormone (TSH) at Screening. Treatment with a stable dose of thyroid medication for at least 3 months is permitted.
- •12. Subject has any clinically significant ECG or laboratory abnormalities at Screening and/or Baseline.
- •13. Subject has a documented allergy, hypersensitivity, or intolerance to amphetamine or methylphenidate.
- •14. Subject has a documented allergy, hypersensitivity, or intolerance to any excipients in the test or reference product.
- •15. Subject has a recent history (within the past 6 months) of suspected substance abuse or dependence disorder (excluding nicotine) in accordance with DSM-IV-TR* criteria.
- •16. Subject has a history of seizures (other than
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