Multiple Sclerosis Clinical Trial

Ketamine for MS Fatigue

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.

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Full 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, 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.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Multiple Sclerosis

Phase:

Early Phase 1

Estimated Enrollment:

20

Study ID:

NCT06064162

Recruitment Status:

Recruiting

Sponsor:

Alta Bates Summit Medical Center

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There is 1 Location for this study

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Alta Bates Summit Medical Center
Berkeley California, 94705, United States More Info
Janet Han, RN
Contact
510-204-1757
[email protected]
Lilly Murray, RN
Contact
510-204-1608
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Early Phase 1

Estimated Enrollment:

20

Study ID:

NCT06064162

Recruitment Status:

Recruiting

Sponsor:


Alta Bates Summit Medical Center

How clear is this clinincal trial information?

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