Using ketamine to reduce fatigue in multiple sclerosis patients

A Pilot Study of Intravenous, Subanesthetic Dose of Ketamine Versus Placebo, A Crossover Design, for Multiple Sclerosis Related Fatigue

This study is testing if low-dose ketamine can help reduce fatigue in people with multiple sclerosis.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Alta Bates Summit Medical Center (Academic / other)
• Locations: 1 site (Berkeley, California)
• Trial ID: NCT06064162 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of ketamine on reducing fatigue in patients with Multiple Sclerosis (MS). It employs a prospective, crossover, randomized, placebo-controlled design, where participants will receive either ketamine or a saline placebo in two separate 28-day cycles. Each participant will be randomized to one of the two treatment groups for their first infusion and will switch to the other treatment for the second infusion. The study aims to assess both the efficacy and safety of low-dose ketamine in alleviating MS-related fatigue.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with any form of clinically definite MS who experience significant fatigue impacting their quality of life.

Not a fit: Patients with untreated sleep apnea, significant comorbid conditions, or those who have had an MS relapse within 90 days prior to the baseline visit may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from fatigue due to Multiple Sclerosis.

How similar studies have performed: While the use of ketamine for various conditions has shown promise, this specific application for MS-related fatigue is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. Female and Male patients with any form of CDMS ages 18-65 inclusive
2. Report fatigue which is interfering with QOL
3. Able and willing to sign informed consent
4. Stable on DMT for at least 3 months prior to baseline visit
5. Not experiencing an MS relapse within 90 days prior to baseline visit.
6. Must agree to practice an acceptable method of contraception
7. Experiencing significant fatigue due to MS (MFIS of ≥10)

Exclusion Criteria:

1. Allergy to Ketamine
2. Taking medications which may interact with ketamine
3. Change in DMT within 3 months prior to baseline visit
4. MS relapse within 90 days of the baseline visit
5. Confirmed diagnosis of untreated Sleep Apnea
6. Confirmed diagnosis of periodic limb movement disorder
7. Serious infection in the 30 days prior to baseline visit.
8. Patients with significant comorbid conditions:

   1. Untreated hypertension (SBP\>160, DBP\>100 at baseline)
   2. Liver disease
   3. Significant renal disease
   4. History of cardiac arrhythmia
   5. Any comorbidities which at the opinion of the investigators post undue risk
9. Current alcohol or drug abuse
10. Participation in another interventional clinical trial in the past 3 months.
11. Pregnant or lactating
12. Any condition which in the opinion of the investigators will cause safety concerns for the patient, or inability to comply with the protocol.

Where this trial is running

Berkeley, California

• Alta Bates Summit Medical Center — Berkeley, California, United States (Recruiting)

Study contacts

• Principal investigator: Deepak Soneji, MD — Sutter East Bay Medical Foundation
• Study coordinator: Deepak Soneji, MD

Conditions Multiple Sclerosis; MS related Fatigue