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NMDA Receptor Antagonist

Ketamine for Multiple Sclerosis Fatigue (INKLING-MS Trial)

Phase 2

Recruiting

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject must be ambulatory (able to walk at least 20 feet using bilateral assistance)

Subject must be a man or woman, 18 to 65 years of age, inclusive

Must not have

Currently treated for active malignancy

History of severe liver disease, including cirrhosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (infusion visit) through four weeks after the infusion.

Awards & highlights

No Placebo-Only Group

Summary

This trialwill test if ketamine can be used to reduce fatigue in people with Multiple Sclerosis.

Who is the study for?

This trial is for ambulatory adults aged 18-65 with Multiple Sclerosis (MS) who suffer from fatigue as a main symptom. They must meet specific MS diagnostic criteria, have stable health, and be on a consistent dose of any current fatigue medication. Exclusions include severe depression, active cancer treatment, certain heart or liver conditions, substance abuse within the last year, and allergies to ketamine or midazolam.

What is being tested?

The study tests low-dose intravenous ketamine against an active placebo (midazolam) for treating MS-related fatigue. It's phase II, randomized (participants are randomly assigned to one of the two treatments), double-blind (neither participants nor researchers know who gets which treatment), and involves parallel groups where each group receives different treatments.

What are the potential side effects?

Ketamine may cause side effects like changes in blood pressure and heart rate, dizziness, blurred vision, nausea or vomiting. Midazolam can also lead to drowsiness or sedation after administration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can walk at least 20 feet with some help.

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently receiving treatment for cancer.

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I have a history of severe liver disease or cirrhosis.

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I have a history of heart disease or heart failure.

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I have had a stroke or brain aneurysm in the past.

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My blood pressure is not controlled with medication.

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I have a known cause for my fatigue, like sleep apnea or thyroid issues.

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I have a history of seizures or epilepsy.

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I have MS but no other brain disorders.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (infusion visit) through four weeks after the infusion.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (infusion visit) through four weeks after the infusion.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (infusion visit) through four weeks after the infusion. for reporting.