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Low-dose ketamine infusion for the treatment of multiple sclerosis fatigue (INKLING-MS): Study protocol for a
Mahsa Ghajarzadeh1, Samantha Roman1, Lauren Vega1
1Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Background:
Fatigue is one of the most common symptoms of people with Multiple Sclerosis (MS). However, currently-used medications for the treatment of fatigue probably do not work better than a placebo. In a pilot trial, we showed that one infusion of low-dose ketamine significantly improved fatigue severity measured four weeks after the infusion.
Methods:
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. Participants will be randomized 1:1:1 into three groups: receiving either one or two infusions of ketamine (0.5 mg/kg over 40 min) or zero to one infusion of the active placebo (midazolam, 0.05 mg/kg over 40 min). Eligibility criteria include adult patients diagnosed with MS based on the latest criteria, complaining of fatigue as one of the main symptoms, and having a screening MFIS score higher than a pre-specified threshold.
Results:
One hundred and ten participants will be randomized over 30 months at Johns Hopkins MS Center. Complete enrollment is expected by mid-2025. The study's primary outcome will be the MFIS score at the end of week 4, comparing two-thirds of the participants who received ketamine with one-third who received midazolam. The secondary and exploratory outcomes (measured four weeks after the second infusion) will show how long the effects of a single infusion last and if two infusions of ketamine are better than one in improving MS fatigue.
Conclusion:
This study can show whether intervening in the glutamatergic pathways would improves MS fatigue.
Insights
Low-dose ketamine infusions show promise for treating Multiple Sclerosis (MS) fatigue, a common and difficult symptom. This trial investigates ketamine
Area of Science:
- Neuroscience
- Clinical Trials
- Neurology
Background:
- Fatigue is a primary and debilitating symptom for many individuals with Multiple Sclerosis (MS).
- Current treatments for MS-related fatigue often demonstrate efficacy comparable to placebo.
- Pilot studies suggest low-dose ketamine infusions may significantly alleviate MS fatigue.
Purpose of the Study:
- To evaluate the efficacy of intravenous low-dose ketamine in treating fatigue in patients with Multiple Sclerosis (MS).
- To compare the effects of one versus two ketamine infusions against an active placebo (midazolam).
- To determine the duration of ketamine's therapeutic effects on MS fatigue.
Main Methods:
- A single-center, phase II, randomized, double-blind, parallel-group, active-placebo-controlled trial.
- 110 participants with MS fatigue will be randomized 1:1:1 to receive one or two ketamine infusions (0.5 mg/kg) or midazolam (0.05 mg/kg).
- Primary outcome: Multidimensional Fatigue Inventory (MFIS) score at week 4; secondary outcomes assess sustained effects and dose-response.
Main Results:
- Enrollment of 110 participants is planned over 30 months, with completion expected by mid-2025.
- The primary endpoint will compare MFIS scores at week 4 between ketamine recipients and the midazolam group.
- Secondary outcomes will assess the longevity of fatigue improvement and compare single versus double ketamine infusions.
Conclusions:
- This study aims to validate the therapeutic potential of targeting glutamatergic pathways for MS fatigue.
- Findings will inform the development of novel pharmacological interventions for MS-related fatigue.
