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Completed

NCT Number: NCT06064162

Ketamine for MS Fatigue

The purpose of this study is to see whether using ketamine to increase glutamate in the prefrontal cortex can reduce Multiple Sclerosis (MS) related fatigue. The investigator proposes a prospective, crossover, randomized, placebo-controlled study to assess the efficacy and safety of low, single dose Ketamine, to assess its efficacy and safety in patients with MS-related fatigue.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Alta Bates Summit Medical Center

Berkeley, California, 94705, United States

About this study

The study treatment is designed in two 28-day cycles: for each cycle, participants will receive study infusion on Day 1 and complete follow-up visits during Days 7 and 28. Participants are randomized 1:1 to receive either ketamine (active treatment) or saline solution (placebo treatment) for their first infusion. They will not be blinded to their study assignment: the study doctor will disclose their assigned treatment group.

After their first infusion cycle, participents will crossover to the other treatment group. Worded differently, if a participant received ketamine during their first infusion, they will receive placebo treatment during their second infusion. Conversely, if a participant received saline treatment during their first infusion, they will receive ketamine during their second infusion.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Allergy to Ketamine
  • Taking medications which may interact with ketamine
  • Change in DMT within 3 months prior to baseline visit
  • MS relapse within 90 days of the baseline visit
  • Confirmed diagnosis of untreated Sleep Apnea
  • Confirmed diagnosis of periodic limb movement disorder
  • Serious infection in the 30 days prior to baseline visit.
  • Patients with significant comorbid conditions:
  • Untreated hypertension (SBP>160, DBP>100 at baseline)
  • Liver disease
  • Significant renal disease
  • History of cardiac arrhythmia
  • Any comorbidities which at the opinion of the investigators post undue risk
  • Current alcohol or drug abuse
  • Participation in another interventional clinical trial in the past 3 months.
  • Pregnant or lactating
  • Any condition which in the opinion of the investigators will cause safety concerns for the patient, or inability to comply with the protocol.

Treatment and study plan

ketamine

Drug

60mg (.5mg/kg over 40 minutes intravenously)

Other names: Ketalar

Primary outcomes

  1. Improve Fatigue Scores

    Time frame: 28 days post study drug infusion

    a statistically significant change in the level of fatigue score as measured by the Multiple Schlerosis fatigue scales: Modified Fatigue Impact Scale (MFIS) between baseline and day 28 post study drug infusion. Rating scale is 0 to 4 with 0 being "never" and 4 being "almost always."

Secondary outcomes

  1. Improve Quality of Life

    Time frame: Between baseline and day 28

    A statistically significant change in the patient's quality of life as measured by Functional Index for Living with Multiple Sclerosis (FILMS) between baseline and day 28. Score is rated 1 to 5 with 1 being "bad" and 5 being "good."

Sponsors and collaborators

Lead sponsor

Alta Bates Summit Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 3, 2023
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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