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Ketamine for MS Fatigue

CompletedEARLY_Phase 1

Sponsor: Alta Bates Summit Medical Center

Conditions: Multiple Sclerosis

Interventions: ketamine

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Berkeley, California, United States