Ketamine for Multiple Sclerosis Fatigue
(INKLING-MS Trial)
Trial Summary
What is the purpose of this trial?
The proposed study is a single-center, phase II, randomized, double-blind, parallel-group, active-placebo-controlled trial of intravenous low-dose ketamine in patients with MS fatigue.
Do I need to stop my current medications for the trial?
You can continue taking your current medication for fatigue if it's not one of the disallowed therapies. You must have been on a stable dose for at least four weeks before the trial and be willing to keep the same dose during the study.
Is there any evidence that the drug ketamine can help with fatigue in multiple sclerosis?
While there is no direct evidence from the provided research about ketamine's effectiveness for multiple sclerosis fatigue, ketamine has been studied for its effects on depression, which is often linked to fatigue in MS. Additionally, other treatments like vitamin B12 have shown some promise in reducing fatigue in conditions similar to MS, suggesting that exploring different treatments for fatigue could be beneficial.12345
Is ketamine safe for human use?
How does the drug ketamine differ from other treatments for multiple sclerosis fatigue?
Research Team
Bardia Nourbakhsh, MD
Principal Investigator
Johns Hopkins University
Eligibility Criteria
This trial is for ambulatory adults aged 18-65 with Multiple Sclerosis (MS) who suffer from fatigue as a main symptom. They must meet specific MS diagnostic criteria, have stable health, and be on a consistent dose of any current fatigue medication. Exclusions include severe depression, active cancer treatment, certain heart or liver conditions, substance abuse within the last year, and allergies to ketamine or midazolam.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive infusions of ketamine or midazolam according to their assigned group, with infusions four weeks apart
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Ketamine
Ketamine is already approved in United States, European Union, Canada for the following indications:
- Anesthesia
- Treatment-resistant depression
- Anesthesia
- Treatment-resistant depression
- Treatment-resistant depression
- Treatment-resistant depression
- Treatment-resistant depression
Find a Clinic Near You
Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor
United States Department of Defense
Collaborator