Ketamine for Multiple Sclerosis Fatigue

Launched by JOHNS HOPKINS UNIVERSITY · May 12, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating the effects of a low-dose intravenous ketamine treatment for people with fatigue caused by multiple sclerosis (MS). The study aims to find out if ketamine can help reduce fatigue in patients who experience this as one of their main symptoms. It is a phase II trial, meaning researchers are examining the treatment's effectiveness and safety after initial studies. The trial is currently recruiting participants who are between 18 to 65 years old, have been diagnosed with MS, and struggle with significant fatigue. Participants should be able to walk at least 20 feet with assistance and must have access to the internet and a device to communicate with the research team.

If eligible, participants will be randomly assigned to receive either the ketamine treatment or a placebo (a substance with no active effect) over a certain period. Throughout the trial, they will be monitored for any changes in their fatigue levels and overall health. It’s important to note that individuals with certain medical conditions, such as severe depression or uncontrolled high blood pressure, and those currently taking specific medications for fatigue may not qualify for the study. This trial offers a chance to explore a new treatment option, and participants will help contribute to the understanding of how to better manage fatigue in MS patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.