CompletedEarly phase 1MS (type not specified)NCT06064162

What it found

Result in a paper, not read yet

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Ketamine

What it measured

Main measures

  • Improve Fatigue Scores

    28 days post study drug infusion

    Fatigue

Other measures (1)

  • Improve Quality of Life

    Between baseline and day 28

    Quality of life (reported by participants)

Who could take part

MS (type not specified) · 18 to 65

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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Related trials

History

    1. Started

      Dec 2023

    2. Main results due

      May 2025

    3. Finished

      May 2025

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