Ketamine for MS Fatigue
Completed · Early Phase 1 · Has a placebo group
Conditions studied: Multiple Sclerosis
In brief
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.
Key facts
- Study ID
- NCT06064162
- Run by
- Alta Bates Summit Medical Center
- People needed
- 21
- Starts
- 2023-12-05
- Expected to finish
- 2025-05-05
- Last updated by the study team
- 2025-06-08
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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.
Where it is running
- Alta Bates Summit Medical Center — Berkeley, California, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.