← Back to Search

NMDA Receptor Antagonist

Ketamine for Multiple Sclerosis Fatigue (INKLING-MS Trial)

Phase 2
Recruiting
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject must be ambulatory (able to walk at least 20 feet using bilateral assistance)
Subject must be a man or woman, 18 to 65 years of age, inclusive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (infusion visit) through four weeks after the infusion.
Awards & highlights

INKLING-MS Trial Summary

This trialwill test if ketamine can be used to reduce fatigue in people with Multiple Sclerosis.

Who is the study for?
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.Check my eligibility
What is being tested?
The study tests low-dose intravenous ketamine against an active placebo (midazolam) for treating MS-related fatigue. It's phase II, randomized (participants are randomly assigned to one of the two treatments), double-blind (neither participants nor researchers know who gets which treatment), and involves parallel groups where each group receives different treatments.See study design
What are the potential side effects?
Ketamine may cause side effects like changes in blood pressure and heart rate, dizziness, blurred vision, nausea or vomiting. Midazolam can also lead to drowsiness or sedation after administration.

INKLING-MS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can walk at least 20 feet with some help.
Select...
I am between 18 and 65 years old.

INKLING-MS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (infusion visit) through four weeks after the infusion.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (infusion visit) through four weeks after the infusion. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Modified Fatigue Impact Scale (MFIS) Score
Secondary outcome measures
Beck Depression Inventory-II (BDI-II)
Epworth Sleepiness Scale (ESS)
Fatigue Severity Scale (FSS)

INKLING-MS Trial Design

3Treatment groups
Experimental Treatment
Group I: Midazolam-KetamineExperimental Treatment2 Interventions
Participants in this arm will receive one infusion of midazolam followed four weeks later by an infusion of ketamine.
Group II: Ketamine-MidazolamExperimental Treatment2 Interventions
Participants in this arm will receive one infusion of ketamine followed four weeks later by an infusion of midazolam.
Group III: Ketamine-KetamineExperimental Treatment1 Intervention
Participants in this arm will receive two infusions of ketamine four weeks apart.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Midazolam
2018
Completed Phase 4
~1910
Ketamine
2011
Completed Phase 4
~1090

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,259 Previous Clinical Trials
14,820,543 Total Patients Enrolled
30 Trials studying Multiple Sclerosis
2,527 Patients Enrolled for Multiple Sclerosis
United States Department of DefenseFED
861 Previous Clinical Trials
227,084 Total Patients Enrolled
11 Trials studying Multiple Sclerosis
724 Patients Enrolled for Multiple Sclerosis

Media Library

Ketamine (NMDA Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05378100 — Phase 2
Multiple Sclerosis Research Study Groups: Midazolam-Ketamine, Ketamine-Ketamine, Ketamine-Midazolam
Multiple Sclerosis Clinical Trial 2023: Ketamine Highlights & Side Effects. Trial Name: NCT05378100 — Phase 2
Ketamine (NMDA Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05378100 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any potential risks associated with Ketamine-Ketamine treatments?

"After careful review, our team at Power rated the safety of Ketamine-Ketamine as a 2. This is because this Phase 2 trial has provided evidence for its safety but not yet established efficacy in any way."

Answered by AI

Is this research initiative still recruiting participants?

"Affirmative. Clinicaltrials.gov details that this ongoing research project, initially posted on January 1st 2023, is presently recruiting participants. The medical trial requires the enrollment of 110 patients from a solitary study site."

Answered by AI

Does the research protocol include participants aged 20 years or older?

"This trial requires that subjects be between 18 to 65 years old. There are 54 studies tailored for minors, and 518 research efforts dedicated to the elderly population."

Answered by AI

How many participants are accepted into this experiment?

"Affirmative, according to clinicaltrials.gov this research is presently on the lookout for participants. It was initiated on January 1st 2023 and has been updated as recently as April 1st 2023. The study requires 110 individuals from a single medical facility."

Answered by AI

Who has the option to partake in this research project?

"This clinical trial involves 110 participants aged 18-65 who suffer from fatigue, and must satisfy several additional criteria: gender (male or female), physical stability, McDonald 2017 multiple sclerosis diagnosis based on personal records, ambulatory capacity for at least 20 feet with assistance, access to internet and email devices such as computers/tablets/smartphones; in addition patients may be taking medication designed to alleviate their condition so long as it does not conflict with the study's disallowed therapies. Furthermore these medications should have already been taken consistently over a four week period prior to the screening visit and continue unchanged during the course of the experiment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Ketamine for Multiple Sclerosis Fatigue
2023. "Ketamine for Multiple Sclerosis Fatigue". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05378100.
~60 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top