A Pilot Study of Intravenous, Subanesthetic Dose of Ketamine Versus Placebo, A Crossover Design, for Multiple Sclerosis Related Fatigue
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Improve Fatigue Scores
研究概览
简要总结
The purpose of this study is to see whether using ketamine to increase glutamate in the prefrontal cortex can reduce Multiple Sclerosis (MS) related fatigue. The investigator proposes a prospective, crossover, randomized, placebo-controlled study to assess the efficacy and safety of low, single dose Ketamine, to assess its efficacy and safety in patients with MS-related fatigue.
详细描述
The study treatment is designed in two 28-day cycles: for each cycle, participants will receive study infusion on Day 1 and complete follow-up visits during Days 7 and 28. Participants are randomized 1:1 to receive either ketamine (active treatment) or saline solution (placebo treatment) for their first infusion. They will not be blinded to their study assignment: the study doctor will disclose their assigned treatment group.
After their first infusion cycle, participents will crossover to the other treatment group. Worded differently, if a participant received ketamine during their first infusion, they will receive placebo treatment during their second infusion. Conversely, if a participant received saline treatment during their first infusion, they will receive ketamine during their second infusion.
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
- None
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
- •Female and Male patients with any form of CDMS ages 18-65 inclusive
- •Report fatigue which is interfering with QOL
- •Able and willing to sign informed consent
- •Stable on DMT for at least 3 months prior to baseline visit
- •Not experiencing an MS relapse within 90 days prior to baseline visit.
- •Must agree to practice an acceptable method of contraception
- •Experiencing significant fatigue due to MS (MFIS of ≥10)
排除标准
- •Allergy to Ketamine
- •Taking medications which may interact with ketamine
- •Change in DMT within 3 months prior to baseline visit
- •MS relapse within 90 days of the baseline visit
- •Confirmed diagnosis of untreated Sleep Apnea
- •Confirmed diagnosis of periodic limb movement disorder
- •Serious infection in the 30 days prior to baseline visit.
- •Patients with significant comorbid conditions:
- •Untreated hypertension (SBP>160, DBP>100 at baseline)
- •Liver disease
- •Significant renal disease
- •History of cardiac arrhythmia
- •Any comorbidities which at the opinion of the investigators post undue risk
- •Current alcohol or drug abuse
- •Participation in another interventional clinical trial in the past 3 months.
- •Pregnant or lactating
- •Any condition which in the opinion of the investigators will cause safety concerns for the patient, or inability to comply with the protocol.
研究组 & 干预措施
Ketamine (active treatment)
dose of 0.5 mg/kg intravenously over 40 minutes on day 1
干预措施: ketamine (Drug)
Saline (placebo treatment)
Placebo (saline solution) over 40 minutes on day 1
干预措施: ketamine (Drug)
结局指标
主要结局
Improve Fatigue Scores
时间窗: 28 days post study drug infusion
a statistically significant change in the level of fatigue score as measured by the Multiple Schlerosis fatigue scales: Modified Fatigue Impact Scale (MFIS) between baseline and day 28 post study drug infusion. Rating scale is 0 to 4 with 0 being "never" and 4 being "almost always."
次要结局
- Improve Quality of Life(Between baseline and day 28)