NCT01436955已完成1 期
A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Dose Study to Investigate Safety and Tolerability of RG1662 in Individuals With Down Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 主要终点
- Safety: Incidence of adverse events
研究概览
简要总结
This multi-center, randomized double-blind, placebo-controlled study will assess the safety and tolerability of RG1662 in individuals with Down Syndrome. Eligible subjects will be randomized in cohorts to receive either multiple oral doses of RG1662 or placebo. Anticipated time on study treatment is 38 days.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult individuals, 18 to 30 years of age, with diagnosis of Down Syndrome (confirmed by karyotype)
- •Males and non-pregnant non-lactating females
- •Parent or legal guardian/representative and caregiver willing to give written informed consent
- •Subject willing and assenting or consenting to participate
排除标准
- •Major depressive disorder not adequately controlled by a selective serotonin reuptake inhibitor or a serotonin norepinephrine reuptake inhibitor
- •Subjects meeting clinical diagnostic criteria for autistic spectrum disorder, attention deficit or hyperactivity disorder unlikely to cooperate and take part successfully in the study assessments
- •Subjects with other primary psychiatric diagnosis
- •Subjects with evidence or meeting clinical diagnosis of dementia
- •Subjects with personal history of cardiac abnormalities; patients that have previously undergone congenital heart surgery can be enrolled provided they have no residual complication requiring intervention (e.g. pace maker)
- •Subjects with clinically significant obstructive pulmonary disease or asthma that is not adequately treated (oral steroids are not allowed)
- •Subjects with thyroid dysfunction that is not adequately controlled and stabilized on treatment for at least 8 weeks
- •Subjects with sustained elevated supine blood pressure (SBP/DBP) at rest exceeding 140/90 mmHg or notable resting tachycardia (mean HR > 60 bpm) or blood pressure below 90/40 mmHg
- •Subjects who have taken any other investigational medications within 3 months
- •Body mass index (BMI) > 40 kg/m2
研究组 & 干预措施
A
Experimental
干预措施: RG1662 (Drug)
B
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety: Incidence of adverse events
时间窗: 16 weeks
次要结局
- Pharmacokinetics: Serum concentration/area under the concentration-time curve (AUC)(5-6 weeks)
- Neurocognitive assessment: CANTAB (Computerized battery for assessing motor practice, reaction time and memory)/standard cognitive tests(5-6 weeks)
研究者
相似试验
已完成
3 期
A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin AloneDiabetes Mellitus Type 2NCT01691846Hoffmann-La Roche200
已完成
3 期
A Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus Who Have Not Previously Received Anti-Hyperglycemic TherapyDiabetes Mellitus Type 2NCT01691755Hoffmann-La Roche196
撤回
2 期
A Study of RO5036505 in Patients With Moderate to Severe AsthmaAsthmaNCT00967590Hoffmann-La Roche
终止
1 期
A Study Evaluating the Safety of Tocilizumab in Addition to Standard of Care Premedication Given Before Obinutuzumab + Chlorambucil in Participants With Untreated B-Cell Chronic Lymphocytic Leukemia (B-CLL) and ComorbiditiesB-Cell Chronic Lymphocytic LeukemiaNCT02336048Hoffmann-La Roche38
已完成
不适用
A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast CancerBreast CancerNCT01358877Hoffmann-La Roche4,804