Ketamine for MS Fatigue

September 26, 2023 updated by: Alta Bates Summit Medical Center

A PILOT STUDY OF INTRAVENOUS, SUBANESTHETIC DOSE OF KETAMINE VS PLACEBO, A CROSSOVER DESIGN, FOR MULTIPLE SCLEROSIS RELATED 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. We propose 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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, they 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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ketamine (active treatment)
dose of 0.5 mg/kg intravenously over 40 minutes on day 1
Drug: ketamine
60mg (.5mg/kg over 40 minutes intravenously)
Other Names:
  • Ketalar
Placebo Comparator: Saline (placebo treatment)
Placebo (saline solution) over 40 minutes on day 1
Drug: ketamine
60mg (.5mg/kg over 40 minutes intravenously)
Other Names:
  • Ketalar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 MS fatigue scales between baseline and day 28 post study drug infusion
28 days post study drug infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 FILMS between baseline and day 28
Between baseline and day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alta Bates Summit Medical Center

Investigators

  • Principal Investigator: Deepak Soneji, MD, Sutter East Bay Medical Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

September 26, 2023

First Submitted That Met QC Criteria

September 26, 2023

First Posted (Actual)

October 3, 2023

Study Record Updates

Last Update Posted (Actual)

October 3, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REDI2022MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Sclerosis

Clinical Trials on ketamine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Togo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe