Ketamine for Multiple Sclerosis Fatigue

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: United States Department of Defense
• Treatments: Ketamine; Midazolam

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.