NCT02680379已完成2 期
A Pilot Study Exploring the Safety and Synergistic Effect of a Minocycline/Lovastatin Combined Treatment on the Behavior of Individuals With Fragile X Syndrome; Validation of New Biochemical and Neurophysiological Markers (LovaMiX)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change from baseline Aberrant Behavior Checklist-Community (ABC-C) total score at 8,12 and 20 weeks
研究概览
简要总结
The purpose of this study is to determine whether Lovastatin, Minocycline and the combination Lovastatin/Minocycline are effective in treating behavioral symptoms in Fragile X individuals.
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
- None
入排标准
- 年龄范围
- 8 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Molecular diagnosis of fragile X syndrome
- •The participant must be accompanied his parent, legal tutor or legal representative.
- •Identify a caregiver who spends at least six hours per day with the participant (may be the parent, legal tutor, legal representative or an other person).
- •ABC-C score > 20
- •CGI-Severity score ≥ 4
排除标准
- •Pregnant or breastfeeding participants
- •Previous intolerance/allergy to statins, minocycline or tetracyclines
- •Participants who have taken lovastatin or minocycline in the last 12 weeks
- •Personal history of myopathy, myalgia or high creatine kinase (CK) levels
- •Renal disease / liver disease / disturbed hepatorenal tests
- •Participants taking more than three psychoactive medications (except anticonvulsants)
- •Untreated or uncontrolled hypothyroidism
- •Any other active medical condition
- •Modification of psychoactive treatment in the last 6 weeks prior to randomization
- •Participants under the age of 13 years who have incomplete formation of the crown of their teeth (except possibly their 3rd molars) as shown by panorex
- •Concomitant use of prohibited drugs
- •Prohibited drugs include other hypolipemic including gemfibrozil (or other fibrates) and niacin (nicotinic acid), angiotensin converting enzyme (ACE), cyclosporine, danazol, amiodarone, verapamil and inhibitors P450 (CYP3A4) (itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, inhibitors of HIV protease and nefazodone).
研究组 & 干预措施
Minocycline, then Minocycline/Lovastatin
Experimental
Participants will take minocycline then a combined treatment of minocycline/lovastatin for 3 months.
干预措施: Minocycline, then Minocycline/Lovastatin (Drug)
Lovastatin, then Minocycline/Lovastatin
Experimental
Participants will lovastatin then a combined treatment of minocycline/lovastatin for 3 months
干预措施: Lovastatin, then Minocycline/Lovastatin (Drug)
结局指标
主要结局
Change from baseline Aberrant Behavior Checklist-Community (ABC-C) total score at 8,12 and 20 weeks
时间窗: baseline, 8 weeks, 12 weeks, 20 weeks
次要结局
- Change from baseline Social Responsiveness Scale (SRS) at 8 and 20 weeks(baseline, 8 weeks, 20 weeks)
- Behavior Rating Inventory of Executive Function (BRIEF)(Before treatment and at the end of treatment (weeks 20))
- Anxiety, depression and mood scale (ADAMS), change from baseline to 8 and 20 weeks(baseline, 8 weeks, 20 weeks)
- Clinical Global Impression Scale improvement (CGI-I)(baseline, 8 weeks, 12 weeks, 20 weeks)
- Change from baseline Vineland II; adaptive behaviour scale at 20 weeks(baseline, 20 weeks)
研究者
Francois Corbin
Dr Francois Corbin, MD, PHD, FRCPC
Université de Sherbrooke
研究点 (1)
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