Effects of Sublingual Microencapsulated Glycine on Attentional Difficulties and Hyperactivity in Prepuberal Children - A Placebo-controlled, Double-blind, Randomized, Cross-over Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- SKAMP-Combined rating scale in the classroom setting
研究概览
简要总结
This study is designed to investigate effects on attentional performance and motoric activity of 100 mg microencapsulated glycine (Bidicin® from Biotiki®) compared to placebo after treatment with t.i.d. sublingual doses over 3 weeks each.
The primary objective of the study is to determine the effects on attentional performance and motoric activity of 100 mg microencapsulated Glycine (Bidicin® from Biotiki® ) compared to placebo after treatment with t.i.d. sublingual doses over 3 weeks each in children with low attentional performance and high motoric activity.
A number of 30 prepuberal boys and girls aged 6 - 14 years with low attentional performance and high motoric activity will be enrolled in this study. The prepuberal status will be determined by Tanner stages ≤ 3.
详细描述
Trial Design:
This study has a double-blind, randomized, two-period, cross-over design. The study population will be randomized equally to the sequence 1 (first 3 weeks microencapsulated Glycine, second 3 weeks placebo) or sequence 2 (first 3 weeks placebo, second 3 weeks microencapsulated Glycine). Study Agent/Placebo - Dosage and Route of Administration:
Study Agent/Placebo will first be dispensed at Visit 2 (day 0). Treatment assignments will be made in accordance with the randomization. At each visit (Visit 2 and Visit 3), subjects will receive two blisters for the 3 following weeks. Only qualified personnel may dispense study Agent/Placebo.
Investigational and reference treatment:
100 mg microencapsulated Glycine (Bidicin® from Biotiki® ) Placebo from Biotiki®
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who meet all of the following inclusion criteria will be eligible for enrollment in the study:
- •Male and female subjects aged 6-14 years with Tanner stages 0 to 3 and attentional and/or hyperactivity problems.
- •Subjects with parents or a legal guardian, who will give written informed consent for the child to participate in the study. Additionally, assent to participate must be obtained from all children entering the study if the child is able to judge the nature, the meaning and the significance of the trial. Assent will be documented by the child´s signature on the consent form.
- •Health Status: Subjects must not have clinically significant diseases or clinically significant abnormal laboratory values as assessed during medical history and physical exam.
- •Subjects meeting minimum intelligence requirements: In the opinion of the investigator the subject must generally be functioning at age-appropriate levels academically, which should take into account any prior cognitive or academic testing (basic knowledge of reading, writing and calculating).
- •Subject has an ADHD-RS-IV total score ≥
- •Subjects already receiving behavioral therapies for HKS/ADHD or oppositional defiant disorder may continue to do sor during the course of the trial.
排除标准
- •subjects with psychiatric disorders requiring current pharmacological treatment (e.g. major depression, psychosis)
- •Subjects with psychiatric or somatic conditions that may contraindicate the trial or confound efficacy or safety assessments.
- •Subjects with a history of drug abuse or current use of recreational drugs.
- •History of hypersensitivity to microencapsulated Glycine or placebo.
- •Subjects who are judged by the investigator as likely to be non-compliant with study procedures.
- •Use of any investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
- •History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
研究组 & 干预措施
100 mg microencapsulated Glycine and then Placebo tablets
100 mg microencapsulated Glycine (Bidicin® from Biotiki® ) t.i.d. for the first three weeks and then Placebo t.i.d. from Biotiki® for the second three weeks.
干预措施: microencapsulated Glycine (Other)
100 mg microencapsulated Glycine and then Placebo tablets
100 mg microencapsulated Glycine (Bidicin® from Biotiki® ) t.i.d. for the first three weeks and then Placebo t.i.d. from Biotiki® for the second three weeks.
干预措施: Placebo tablets (Other)
Placebo tablets and then 100 mg microencapsulated Glycine
Placebo t.i.d. from Biotiki® for the first three weeks and then 100 mg microencapsulated Glycine (Bidicin® from Biotiki® ) t.i.d. for the second three weeks.
干预措施: microencapsulated Glycine (Other)
Placebo tablets and then 100 mg microencapsulated Glycine
Placebo t.i.d. from Biotiki® for the first three weeks and then 100 mg microencapsulated Glycine (Bidicin® from Biotiki® ) t.i.d. for the second three weeks.
干预措施: Placebo tablets (Other)
结局指标
主要结局
SKAMP-Combined rating scale in the classroom setting
时间窗: 3 weeks
SKAMP-Combined rating performed at 25 minutes before and 0:50 h, 1,55 h, 2:50 h, 4:05 h, 5:50 h, 7:40 h and 8:35 h after first microencapsulated Glycine/ placebo intake in a laboratory classroom setting after a 3 week treatment period. The primary efficacy endpoint is the mean of the SKAMP-Combined score over all time points in the classroom setting.
次要结局
- SKAMP-Attention subscale(3 weeks)
- Child Behaviour Checklist (CBCL)(3 weeks)
- Saliva cortisol levels(3 weeks)
- ADHD-Rating scale-IV(3 weeks)
- SKAMP-Deportment subscale(3 weeks)
- Quality of life scores(3 weeks)
- Visual-Analogue-Scale of perceived parental stress(3 weeks)
- Adverse Events that are related or not related to treatment(3 weeks)
研究者
Eberhard Schulz
Prof. Dr.
University Hospital Freiburg