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Ketamine for MS Fatigue

Phase < 1
Recruiting
Led By Deepak Soneji, MD
Research Sponsored by Alta Bates Summit Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Experiencing significant fatigue due to MS (MFIS of ≥10)
Be older than 18 years old
Must not have
Confirmed diagnosis of untreated Sleep Apnea
Serious infection in the 30 days prior to baseline visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up between baseline and day 28
Awards & highlights

Summary

This trial studies if low-dose ketamine can reduce fatigue in people with Multiple Sclerosis (MS). A safe, randomized, placebo-controlled study will assess its effectiveness.

Who is the study for?
This trial is for men and women aged 18-65 with any form of chronic MS, who suffer from fatigue that affects their quality of life. Participants must have been stable on disease-modifying therapy for at least three months, not be pregnant or breastfeeding, use contraception, and not have had an MS relapse in the last 90 days.
What is being tested?
The study tests if a low dose of ketamine can alleviate fatigue in MS patients by increasing glutamate in the prefrontal cortex. It's a crossover study where participants randomly receive either ketamine or placebo first, then switch to the other after a period.
What are the potential side effects?
Ketamine may cause side effects such as changes in blood pressure and heart rate, dizziness, nausea, blurred vision, feelings of detachment from reality or body (dissociation), mood swings, and potentially liver issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I experience significant fatigue from my MS.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with Sleep Apnea but haven't received treatment.
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I have not had a serious infection in the last 30 days.
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My blood pressure is not controlled and is above 160/100.
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I have a history of irregular heartbeats.
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I have a serious kidney condition.
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I have been diagnosed with periodic limb movement disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~between baseline and day 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and between baseline and day 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Improve Fatigue Scores
Secondary outcome measures
Improve Quality of Life

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Ketamine (active treatment)Active Control1 Intervention
dose of 0.5 mg/kg intravenously over 40 minutes on day 1
Group II: Saline (placebo treatment)Placebo Group1 Intervention
Placebo (saline solution) over 40 minutes on day 1

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Who is running the clinical trial?

Alta Bates Summit Medical CenterLead Sponsor
4 Previous Clinical Trials
289 Total Patients Enrolled
Deepak Soneji, MDPrincipal InvestigatorSutter East Bay Medical Foundation
~12 spots leftby Dec 2025
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