NCT00637221已完成1 期
An Open Label Exploratory Study to Investigate the Safety and Effects of NPL-2009 ( 50 mg - 150 mg Single Dose) on Prepulse Inhibition Tests and Continuous Performance Tasks, in Adults With Fragile X Syndrome
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Neuropharm
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- The primary outcome measure for the study is that of safety and subjects will be assessed post-dose at at least hourly intervals for any signs of Adverse Events - up to allowing discharge from the unit at 6 hours post-dose
研究概览
简要总结
This is an open label exploratory study to investigate the safety and effects of a single dose of NPL-2009(50 mg - 150 mg) on Prepulse Inhibition (PPI) Tests and Continuous Performance Tasks (CPT) in adults with Fragile X Syndrome
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients, 18 to 45 years of age.
- •Diagnosis of Fragile X Syndrome.
- •Females must demonstrate a negative pregnancy test at screening.
- •Females of child-bearing potential must be using a medically accepted means of contraception or must remain abstinent for the duration of the study.
- •Each Legally Authorised Representative (LAR, usually parent or caregiver) must have a level of understanding sufficient to provide written informed consent to all required study tests and procedures.
- •Each patient must consent/assent (depending on center-specific procedures) to all required study tests and procedures.
- •Permitted concomitant medications must be stable for at least 6 weeks prior to enrollment. The following concomitant medications are permitted: psychostimulants, SSRIs, atypical antipsychotics, anticonvulsants which do not have liver inducing effects, clonidine.
- •Each patient must be able to swallow the capsules (2, 3 or 4) to be provided in the study.
排除标准
- •Current treatment with anticonvulsants known to induce liver enzymes e.g. depakote
- •Current treatment with N-methyl-D-aspartate (NMDA) antagonists
- •Current treatment with tricyclic antidepressants
- •Current treatment with typical antipsychotics
- •Current treatment with lithium
- •Patients planning to commence cognitive behaviour therapy during the period of the study or those who have begun cognitive behavioural therapy within 6 weeks prior to enrolment.
- •History of, or current cardiovascular, renal, hepatic, respiratory and particularly gastrointestinal disease which may interfere with the absorption, distribution, metabolism or excretion of the study medication.
- •History of, or current cerebrovascular disease or brain trauma.
- •History of, or current significant endocrine disorder, e.g. hypo or hyperthyroidism.
- •History of, or current malignancy.
- •Presence of psychotic symptoms or lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder, as assessed by the Investigator.
- •Current major depressive disorder (patients must be free of the disorder for 3 months prior to enrolment).
- •Judged clinically to be at risk of suicide (suicidal ideation, severe depression, or other factors), as assessed by the Investigator.
- •Tourette's Disorder.
- •Female patients who are either pregnant or nursing.
- •Current drug abuse or dependence disorder or dependency in the 3 months prior to enrolment.
- •Clinically significant abnormalities in safety laboratory tests, vital signs or EKG, as measured at screening
- •Patients with significant hearing and/or visual impairments that may affect their ability to complete the test procedures
- •Enrollment in another clinical trial within the previous 30 days
结局指标
主要结局
The primary outcome measure for the study is that of safety and subjects will be assessed post-dose at at least hourly intervals for any signs of Adverse Events - up to allowing discharge from the unit at 6 hours post-dose
时间窗: 7 Days
次要结局
- Tolerability(7 days)
研究者
研究点 (4)
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