NCT06064162CompletedEarly phase 1
Ketamine for MS Fatigue
A Pilot Study of Intravenous, Subanesthetic Dose of Ketamine Versus Placebo, A Crossover Design, for Multiple Sclerosis Related Fatigue
Source: ClinicalTrials.gov · Last updated 8 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 21 (actual)
- First submitted
- 26 Sept 2023
- Start date
- 5 Dec 2023
- Primary completion date
- 5 May 2025
- Lead sponsor
- Alta Bates Summit Medical Center
- Diseases
- Multiple sclerosis
- NCT number
- NCT06064162
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 21
- From 5 Dec 2023 to the primary completion date, 5 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Taking medications which may interact with ketamine
- Change in DMT within 3 months prior to baseline visit
- Serious infection in the 30 days prior to baseline visit.
- Current alcohol or drug abuse
Other illness
- Allergy to Ketamine
- Confirmed diagnosis of periodic limb movement disorder
- 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
- Any condition which in the opinion of the investigators will cause safety concerns for the patient, or inability to comply with the protocol.
Other
- MS relapse within 90 days of the baseline visit
- Confirmed diagnosis of untreated Sleep Apnea
- Participation in another interventional clinical trial in the past 3 months.
- Pregnant or lactating
Who the study is looking for
- 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)
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Alta Bates Summit Medical Center Coordinator of this site? Confirm its status | Berkeley | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.