Comparison of the Pharmacodynamic and Tolerability Profiles of Minocycline Versus Placebo in Autism Spectrum Disorder: a Double-blind, Placebo-controlled, Crossover, Proof-of-concept Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 3
- 主要终点
- Subject weight will be compared pre- and post-treatment in the drug versus placebo conditions
研究概览
简要总结
The purpose of the study is to determine if Minocycline shows initial evidence of efficacy, safety, and tolerability in youth with Autism Spectrum Disorder ages 12 to 22 years.
详细描述
This is a double-blind, placebo-controlled, crossover, proof-of-concept study that compares the pharmacodynamic and tolerability profiles of minocycline versus placebo in autism spectrum disorder.
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
- 12 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •22 ≥ Age ≥12 years. Males and females included in study.
- •Diagnostic confirmation of Autism Spectrum Disorder as confirmed by gold standard clinical interview using DSM 5 criteria and administration of the Autism Diagnostic Observation Schedule-2, Module 3 or
- •General good health as determined by physical exam, medical and psychiatric history and safety labs as defined by the PI or designee.
- •Male study participants who are sexually active with a female partner of childbearing potential must be surgically sterilized, practicing abstinence, or agree to use highly effective methods of birth control (defined below), and not rely on barrier methods and spermicide alone, from the time of screening until 1 week after final dose of study drug.
- •Female participants of childbearing potential may be included in the study provided they are practicing abstinence or are using a double barrier method from the time of screening until 1 week after the final dose of study drug. Participants using hormonal methods of birth control (oral, intravaginal, transdermal, injectable, or implantable) must be on a stable dose for at least three months prior to screening.
- •Whole brain absolute cumulative gamma power (30 to 80 Hz) with median cut off at 2.5 (upward adjusted)
排除标准
- •Allergy or hypersensitivity to any of the tetracyclines antibiotics.
- •Inability to swallow study drug.
- •Concomitant use of scheduled anti-inflammatory drugs with the exception of as needed ibuprofen or acetaminophen use.
- •Unstable dosing of any mood, anxiety or behavior medications in the 5 half-lives prior to Phase 1 baseline visit.
- •Concomitant use of scheduled benzodiazepines, baclofen, gabapentin, pregabalin, or supplements with impact on the GABA system.
- •Concomitant daily use of antacids
- •Concomitant use of oral acne medications (isotretinoin), not including lotions or creams applied to the skin
- •Concomitant use of any cannabinoid or related product.
- •Unstable seizure disorder as defined by any seizure in the 6 months prior to baseline visit and/or a change in any anti-convulsant drug dosing in the 60 days prior to study screen.
- •Abnormal baseline safety lab assessments including, but not limited to ALT or AST greater than 1.5x the upper limit of normal, elevated ANA, total bilirubin or creatinine greater than 1x the upper limit of normal, other clinically relevant lab abnormality, or abnormality in ECG, HR or BP at screening as determined by the investigator or designee.
- •History of autoimmune disorder
- •History of or current abuse of drugs or alcohol including prescription medication.
- •Women who are pregnant (i.e. have a positive pregnancy test), intending to become pregnant, breast feeding, or women of child-bearing potential who are unwilling to use contraception as required in the study inclusion criteria or maintain abstinence during the course of the study
- •Inability to attend scheduled study visits, plans for family relocation during the study, or any other criteria that the investigator may determine to be associated with inability to complete the study
研究组 & 干预措施
Minocycline versus Placebo
Phase 1: 4 weeks of daily minocycline 100mg BID dosing
2-week washout period
Phase 2: 4 weeks of daily placebo dosing
干预措施: Minocycline (Drug)
Minocycline versus Placebo
Phase 1: 4 weeks of daily minocycline 100mg BID dosing
2-week washout period
Phase 2: 4 weeks of daily placebo dosing
干预措施: Placebos (Drug)
Placebo versus Minocycline
Phase 1: 4 weeks of daily placebo dosing
2-week washout period
Phase 2: 4 weeks of daily minocycline 100mg BID dosing
干预措施: Minocycline (Drug)
Placebo versus Minocycline
Phase 1: 4 weeks of daily placebo dosing
2-week washout period
Phase 2: 4 weeks of daily minocycline 100mg BID dosing
干预措施: Placebos (Drug)
结局指标
主要结局
Subject weight will be compared pre- and post-treatment in the drug versus placebo conditions
时间窗: Through study completion, an average of 2 years
Subject weight will be measured in kilograms
Aberrant Behavior will be evaluated pre- and post-treatment in the drug versus placebo conditions
时间窗: Through study completion, an average of 2 years
Aberrant behavior will be measured by the Aberrant Behavior Checklist total score
Incidence of liver toxicity will be evaluated in the pre- and post-treatment setting in the drug versus placebo conditions
时间窗: Through study completion, an average of 2 years
Liver toxicity will be defined as the development of an ALT or AST value greater than twice the upper limit of normal during a treatment period
次要结局
未报告次要终点