Status:
COMPLETED
Ketamine for MS Fatigue
Lead Sponsor:
Alta Bates Summit Medical Center
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
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. The investigator proposes a prospective, c...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2025
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT06064162
Start Date
December 5 2023
End Date
May 5 2025
Last Update
June 8 2025
Active Locations (1)
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1
Alta Bates Summit Medical Center
Berkeley, California, United States, 94705