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Could a Low-Dose ketamine infusion beat MS fatigue?

NCT ID NCT05378100

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tests whether a single low-dose ketamine infusion can reduce fatigue in people with multiple sclerosis. About 110 adults with MS-related fatigue will receive either ketamine or a mild sedative (midazolam) as a placebo. The study measures changes in fatigue scores over time to see if ketamine offers meaningful relief.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ketamine
What this could lead to
If it works, this could point toward a new treatment option for fatigue in multiple sclerosis, improving daily energy and quality of life.
What could go wrong
This is a small, early-phase trial (110 people) with an active placebo, so results may not be conclusive. Ketamine can cause side effects like dizziness or dissociation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 110 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2023

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Johns Hopkins University

    Baltimore, Maryland, 21287, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.