Low-Dose Ketamine Infusion for the Treatment of Multiple Sclerosis Fatigue (INKLING-MS)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Modified Fatigue Impact Scale (MFIS) Score
研究概览
简要总结
The proposed study is a single-center, phase II, randomized, double-blind, parallel-group, active-placebo-controlled trial of intravenous low-dose ketamine in patients with MS fatigue.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be a man or woman, 18 to 65 years of age, inclusive.
- •Subject must be medically stable based on physical examination, medical history, and vital signs
- •Subject must meet McDonald 2017 diagnostic criteria for multiple sclerosis based on the PI review of the medical records
- •Subject must complain from fatigue as one of their main symptoms and have a screening MFIS score equal or higher than the cutoff based on gender, age, and education displayed in Table-226
- •Subject must be ambulatory (able to walk at least 20 feet using bilateral assistance)
- •Subject must have internet and email access and ability to use a computer or tablet or smartphone
- •Subjects that are currently taking medication for alleviating fatigue (such as amantadine, modafinil and armodafinil, and amphetamine-like psychostimulants) at Screening are eligible to participate unless the medication is one of the disallowed therapies (Table 3). Subjects taking a fatigue medication at the Screening visit must have been receiving a stable dose for at least four weeks before the Screening visit and be willing to continue the medication at the same dose for the duration of the study.
排除标准
- •BDI-II score of more than 29 (indicating severe depression)
- •Having a known clear cause for secondary fatigue, such as untreated sleep apnea, untreated hypothyroidism, chronic liver disease, history of moderate to severe anemia (hemoglobin concentration of less than 9 gr/dl in men or less than 8 gr/dl in women).
- •Neurodegenerative disorders other than relapsing or progressive MS
- •Breastfeeding or pregnant
- •History of coronary artery disease or congestive heart failure
- •Uncontrolled hypertension at Screening (history of high blood pressure and screening systolic blood pressure >160 or diastolic blood pressure>100)
- •History of severe liver disease, including cirrhosis
- •Terminal medical conditions
- •Currently treated for active malignancy
- •Alcohol or substance abuse in the past year (except marijuana or other cannabinoids)
- •A history of intolerance or allergic or anaphylactic reaction to ketamine or midazolam
- •Clinically unstable medical or psychiatric disorders that require acute treatment as determined by the PI
- •History of severe or untreated coronary artery disease or history of congestive heart failure
- •History of prior ischemic or hemorrhagic stroke and cerebral vascular aneurysms.
- •History of recurrent seizures or epilepsy
- •Taking any disallowed therapy(ies), as noted in the protocol.
研究组 & 干预措施
Midazolam-Ketamine
Participants in this arm will receive one infusion of midazolam followed four weeks later by an infusion of ketamine.
干预措施: Ketamine (Drug)
Midazolam-Ketamine
Participants in this arm will receive one infusion of midazolam followed four weeks later by an infusion of ketamine.
干预措施: Midazolam (Drug)
Ketamine-Midazolam
Participants in this arm will receive one infusion of ketamine followed four weeks later by an infusion of midazolam.
干预措施: Midazolam (Drug)
Ketamine-Ketamine
Participants in this arm will receive two infusions of ketamine four weeks apart.
干预措施: Ketamine (Drug)
Ketamine-Midazolam
Participants in this arm will receive one infusion of ketamine followed four weeks later by an infusion of midazolam.
干预措施: Ketamine (Drug)
结局指标
主要结局
Modified Fatigue Impact Scale (MFIS) Score
时间窗: Baseline (infusion visit) through four weeks after the infusion.
The total score of the MFIS ranges from 0 to 84. Higher scores denote more severe fatigue.
次要结局
- Epworth Sleepiness Scale (ESS)(Baseline (infusion visit) through four weeks after the infusion.)
- Beck Depression Inventory-II (BDI-II)(Baseline (infusion visit) through four weeks after the infusion.)
- Fatigue Severity Scale (FSS)(Baseline (infusion visit) through four weeks after the infusion.)