COMPLETED

Ketamine for MS Fatigue

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-12-05

Study Completion:2025-05-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06064162

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.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	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.

Inclusion Criteria

Exclusion 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)

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.

Contacts and Locations

Principal Investigator

Deepak Soneji, MD

PRINCIPAL_INVESTIGATOR

Sutter East Bay Medical Foundation

Study Locations (Sites)

Alta Bates Summit Medical Center

Berkeley, California, 94705

United States

Collaborators and Investigators

Sponsor: Alta Bates Summit Medical Center

Deepak Soneji, MD, PRINCIPAL_INVESTIGATOR, Sutter East Bay Medical Foundation

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 Registration Dates

Study Start Date2023-12-05

Study Completion Date2025-05-05

Study Record Updates

Study Start Date2023-12-05

Study Completion Date2025-05-05

Terms related to this study

Keywords Provided by Researchers

MS related Fatigue

Additional Relevant MeSH Terms

Multiple Sclerosis