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Ketamine for MS Fatigue

Sponsor
Alta Bates Summit Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06064162
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
24
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A PILOT STUDY OF INTRAVENOUS, SUBANESTHETIC DOSE OF KETAMINE VS PLACEBO, A CROSSOVER DESIGN, FOR MULTIPLE SCLEROSIS RELATED FATIGUE
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2025
Anticipated Study Completion Date :
Oct 1, 2025

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Improve Fatigue Scores [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

    Secondary Outcome Measures

    1. Improve Quality of Life [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    9. Untreated hypertension (SBP>160, DBP>100 at baseline)

    10. Liver disease

    11. Significant renal disease

    12. History of cardiac arrhythmia

    13. Any comorbidities which at the opinion of the investigators post undue risk

    14. Current alcohol or drug abuse

    15. Participation in another interventional clinical trial in the past 3 months.

    16. Pregnant or lactating

    17. 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

    Locations

    Site City State Country Postal Code
    1 Alta Bates Summit Medical Center Berkeley California United States 94705

    Sponsors and Collaborators

    • Alta Bates Summit Medical Center

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Alta Bates Summit Medical Center
    ClinicalTrials.gov Identifier:
    NCT06064162
    Other Study ID Numbers:
    • REDI2022MS
    First Posted:
    Oct 3, 2023
    Last Update Posted:
    Oct 3, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Alta Bates Summit Medical Center
    MS related Fatigue
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Sclerosis
    Fatigue
    Ketamine

    Study Results

    No Results Posted as of Oct 3, 2023