Clinical Trial: Ketamine for Multiple Sclerosis Fatigue (INKLING-MS)

Funding:

Description

In this study, we aim to show the effect of ketamine on fatigue in 110 people with MS and fatigue, ages 18 to 65. Ketamine is a medication that indirectly increases the release of glutamate (an important chemical messenger) in the brain. We are recruiting 110 people with MS fatigue.

People will be randomly assigned to receive ketamine or midazolam. Midazolam is a medication with no effect on fatigue but some sedative effects to mimic ketamine effects. One-third of participants will receive two infusions of ketamine, four weeks apart, 1/3 will receive one infusion of ketamine, followed by one infusion of midazolam, and 1/3 will receive an infusion of midazolam, followed by an infusion of ketamine. So, all particpants will at least receive one infusion of ketamine. 

Aside from screening and infusion visits, all other evaluations will be done remotely (through phone, text, and email). Most participants will have two in-person visits. Participants will be followed for eight weeks after the first infusion. Fatigue, sleepiness, depression, and pain will be measured by standardized questionnaires before treatment and throughout these eight weeks. We will use a smartphone app to more frequently measure fatigue and its fluctuations and the amount of physical activity.

With this study design, we will be able to answer the study questions (whether ketamine is better than a placebo in improving fatigue if repeated infusions of ketamine are better than one, and if the effects of ketamine last up to eight weeks). 

For further information or to participate please contact:

Bardia Nourbakhsh
bnourba1@jhmi.edu

Mahsa Ghajarzadeh
mghajar2@jhmi.edu

Lauren Vega
ldimarc2@jhmi.edu

Phone: 410-614-1522